AuguSt 2008 genentech no more? Wider - ddn-news.com · acquisition of Bentley ... tain Genentech as an indepen-dent research unit, ... Cellular Analysis System from Roche Applied

enough to entice the holders of the remaining shares to sell, say numerous industry analysts.

In a research note released shortly after the offer, Chicago-

big pharma went south last year.“Years ago, the company

began a collaboration with Procter & Gamble for the intra-nasal delivery technology for osteoporosis, and they gave that program back to Nastech in November 2007,” explains J. Michael French, who began as CEO of mdRNA on June 23 and previously worked as vice president for corporate devel-opment at Sirna Therapeutics Inc. “There wasn’t anything wrong with Nastech’s approach or research, it wasn’t because of safety or tox concerns; P&G

Applied Bio and Integromics collaborate with Novartis on high-throughput analysis platformBy Amy SwindermAn

BASEL, Switzerland—As Novartis Pharma AG con-tinues to focus on gene expression research, the Swiss pharma recently teamed up with Applied Biosystems and Integromics SL to develop a plat-form for seamless analysis of real-time gene expres-

sion data produced during biomarker analysis.The new solution was borne out of a 2007

co-development and marketing agreement between Applied Bio and Integromics that mar-ried Integromics’ Real-Time StatMiner software with Applied Bio’s line of real-time polymerase chain reaction (PCR) systems and TaqMan arrays. Novartis, which recently used TaqMan in a large-scale pilot study, assisted with the collaboration. Financial terms were not released.

AuguSt feAtureFocusing on the ’omicsThe Human Genome Project was just the start. Now NIH is looking to other projects to push the ’omics envelope.

globalnews 6

Stop the bleedingBayer HealthCare acquires Maxygen Inc.’s hemophilia MAXY-VII assets as well as its Molecular Breeding discovery technology for up to $120 million.

Summit lands DMD license U.K.-based pharma antes up $143 million to gain access to BioMarin’s preclinical drug candidate for Duchenne muscular dystrophy.

informatics 12

No gene left behindSophic Systems Alliance Inc. gets National Cancer Institute grant and teams with Biomax Informatics AG to complete the Cancer Gene Index Project by May 2009.

automation&instrumentation 16

Short hairpin, long viewThermo Fisher plugs a gap in its product line, picking up the shRNA and antibody libraries of ‘open source’ company Open Biosystems.

genomics&proteomics 22

Tapping into protein powerAlthea Technologies and Protein’eXpert forge commercial partnership for early- and late-stage protein optimization.

research&development 26

Cinryze and synergyViroPharma acquires Lev Pharmaceuticals and its inflammatory disease program for a potential net aggregate value of $617.5 million.

newproducts 30

AuguSt 2008 Volume 4 Number 8 www.drugdiscoverynews.com

mdrnA coNtiNued oN page 23

Teva snaps up Barr for $7.4 BBy ChriS AnderSon

J E R U S A L E M — L o o k i n g to further widen the gap between it and its nearest generic competitor, Teva Pharmaceuticals—the larg-est generics company in the world—announced in mid-July its intent to acquire New Jersey-based Barr Pharmaceuticals in a cash and stock deal worth more than $7.4 billion. The hun-gry generic maker recently closed on its $350 million ac qu i s it i o n o f B e nt l e y Pharmaceuticals and also p u r c h a s e d C o G e n e sys earlier this year for $400 million.

“The combination of our two companies provides an outstanding opportunity strategically and economi-cally. It will enhance our market share and leader-ship position in the U.S. and key global markets, further strengthen our portfolio and pipeline and provide upside to our stra-tegic plan,” says Teva CEO Shlomo Yanai.

teVA coNtiNued oN page 28

genentech no more? Wider gap in generics

roChe coNtiNued oN page 8

noVArtiS coNtiNued oN page 14

20

High-throughput triple team

Nastech becomes mdrNa and moves rNai tech ahead of nasal deliveryBy Jeffrey Bouley

B O T H E L L , Wa s h . — N a s t e c h Pharmaceutical Co. changed its name to mdRNA in mid-June—along with shifting its focus from nasal drugs to RNAi—in a move that essentially cuts off its nose to reinvent its face.

As Nastech, the company had what it thought was a winning corporate strategy of develop-ing nasal delivery technologies for existing, successful medica-tions. In fact, it had three signifi-cant, ongoing clinical tracks for an ultra-rapid-acting insulin for diabetes, peptide YY3-36 for obe-sity and parathyroid hormone (PTH1-34) for osteoporosis. All that changed when a deal with

a nose For opportunity

reFocuseD. one-time nasal delivery company nastech has refocused on rnai and in the process emerged with a new name: mdrna.

roche offers $43.7 billion for remainder of genetech sharesBy ChriS AnderSon

BASEL, Switzerland—Amid mul-tiple public statements by Roche Chairman Franz Humer that the company intends to main-tain Genentech as an indepen-dent research unit, at press time Roche was holding firm to its initial offer of $89 per share—a total of $43.7 billion—to acquire the remaining 44.1 percent of the company it doesn’t already own.

The offer marks a scant 8.8 percent premium over the clos-ing of Genentech’s shares the day prior and may not be quite

pipeLine pLay: citing an ever-challenging competitive environment, roche chairman Franz humer thinks complete ownership of genentech will help roche remain competitive over the next 20 years.

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statsFor more information, visit www.DrugDiscoveryNews.com AUGUST 2008 • Drug Discovery News 3

Study: Global outsourcing market exceeds $5 billion

BOSTON—The number of new industry-sponsored clinical trial initiations surged 12 per-cent to a record high in 2007, according to a recent study conducted by PAREXEL International Corp., a global pharmaceutical services orga-nization.

According to PAREXEL’s Bi o/ Pha r m a c e u t i cal R& D Statistical Sourcebook 2008-2009, the biopharmaceutical industry submitted 662 com-mercial IND applications in support of new clinical stud-ies for drugs in 2007, up from the previous record of 593 in 2006.

Oncology studies repre-sented the largest percent-age of new clinical studies, comprising nearly 15 percent of the total number of clini-cal trials that were initiated, according to PAREXEL.

There has been a less con-sistent year-over-year pattern for commercial IND submis-sions of therapeutic biological products compared to those for drug products, accord-ing to the study. According to PAREXEL, 83 commer-cial INDs were submitted for therapeutic biological prod-ucts in 2007, which was down 27 percent from 114 submit-ted in 2006, but up 67 percent over submissions in 2005.

PAREXEL’s analysis also includes an assessment of the number of active com-mercial INDs at the FDA Center for Drug Evaluation and Research, which is an indicator of overall clinical research activity. At the end of 2007, 5,417 active commercial INDs were being managed by CDER, compared to 5,445 at the end of 2006. DDN

Clinical trial starts set record high last year

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NEW YORK—With the pharmaceu-tical industry turning to outsourc-ing to access new technologies and expertise while reducing costs, the global drug discovery outsourc-ing market reached $5.4 billion in 2007 and should continue to grow 16 percent annually through 2013, according to a recent report by Kalorama Information.

The report, Outsourcing in Drug Discovery, Third Edition, details the increasing trend for pharmaceuti-cal companies to outsource vari-ous functions of the drug discovery process and details the current and future global market, technology developments and off-shoring in

China, India and Eastern Europe.For the past two decades, the

pharmaceutical industry has out-sourced both non-core functions and core functions such as clinical trial management and manufac-turing. More recently, outsourcing has expanded into the drug discov-ery process following advances in molecular biology and the emer-gence of next generation biological therapies, according to the report.

These advances, together with the emergence of new technologies used to accelerate the discovery of new drugs through enhanced data reliability and analysis, have made it unsustainable for companies to undertake all drug discovery func-tions in-house, as most do not have the expertise or programs to fully utilize these novel technologies, according to Kalorama.

“Outsourcing isn’t a new idea,

but in recent years, it’s become essential in widening the bottle-necks in the drug discovery pro-cess,” says Kalorama Publisher Bruce Carlson. “Double-digit growth will be seen in a wide range of advanced processes, including genomics, proteomics and inte-grated crystallographic data collec-tion and computation techniques.”

However, the report notes that issues over loss of control, intel-

lectual property and confidenti-ality remain a concern for some companies. Added to this are wor-ries about regulatory compliance, political stability and contrac-tor reliability when dealing with offshore CROs. Nonetheless, the benefits outweigh concerns, and since 2001, growth in spending on contract drug discovery has out-paced that of global R&D spend-ing, according to the report. DDN

stocks4 Drug Discovery News • AUGUST 2008 For more information, visit www.DrugDiscoveryNews.com

Symbol Close 52-wk high 52-wk low

High-Cap Biopharmaceuticals

Abbott Laboratories ABT 53.00 61.09 49.58

Alcon ACL 160.43 161.85 126.79

AstraZeneca AZN 41.77 56.60 35.03

Bristol-Myers Squibb BMY 23.25 32.35 20.05

Cardinal Health CAH 55.64 73.00 49.23

Eli Lilly LLY 48.99 60.00 46.60

Forest Laboratories FRX 34.63 56.65 33.32

Gilead Sciences GILD 53.67 54.13 35.22

GlaxoSmithKline GSK 44.89 58.23 40.51

Johnson & Johnson JNJ 67.90 68.85 59.72

Merck & Co. MRK 38.98 61.62 36.80

Novartis NVS 50.67 59.17 46.19

Novo Nordisk NVO 68.61 73.73 50.08

Pfizer PFE 20.52 27.73 19.79

Roche Holding RHHBY.PK 82.35 99.00 81.10

Sanofi-Aventis SNY 39.14 49.04 35.06

Schering-Plough SGP 18.75 33.81 13.83

Wyeth WYE 45.56 62.20 38.39

Mid-Cap Biopharmaceuticals

APP Pharmaceuticals APPX 13.15 27.75 9.56

Amylin Pharmaceuticals AMLN 28.34 53.25 23.75

Barr Pharmaceuticals BRL 50.36 58.38 45.33

Endo Pharmaceuticals ENDP 23.89 35.85 22.62

King Pharmaceuticals KG 9.87 22.25 8.26

Ligand Pharmaceuticals LGND 3.74 7.73 3.31

Medicis Pharmaceutical MRX 20.30 34.35 18.51

Onyx Pharmaceuticals ONXX 37.16 61.18 24.60

Par Pharmaceutical PRX 17.26 30.68 15.51

Shire Pharmaceuticals SHPGY 53.46 81.00 51.95

Valeant Pharmaceuticals VRX 13.15 17.90 10.35

Vertex Pharmaceuticals VRTX 26.28 41.42 13.84

Watson Pharmaceuticals WPI 28.92 33.91 23.90

High- and Mid-Cap Instruments & Suppliers

Applied Biosystems ABI 33.84 33.67 27.79

Beckman Coulter BEC 67.16 77.00 60.27

Bio-Rad BIO 85.25 115.23 68.18

Bruker Biosciences BRKR 12.33 16.66 6.30

Cepheid CPHD 22.88 33.36 10.66

Dionex DNEX 73.59 88.39 64.86

Gen-Probe GPRO 56.65 71.84 44.82

Illumina ILMN 80.80 81.90 31.66

Invitrogen IVGN 93.54 99.15 68.84

Millipore MIL 70.05 83.20 63.82

OSI Systems OSIS 23.74 29.80 19.64

Pall PLL 34.66 49.00 33.37

PerkinElmer PKI 27.08 30.00 21.88

Qiagen QGEN 22.08 23.83 15.22

Roper Industries ROP 62.76 71.01 48.45

Thermo Fisher TMO 57.44 62.02 46.63

Varian VARI 49.15 78.27 48.77

Waters WAT 62.41 81.84 51.92

SToCk WATCh Stock prices reflect end of day tradingAugust 1, 2008

Strong international sales boost Pfizer’s Q2 profits

NEW YORK—Fueled by strong international phar-maceutical sales, Pfizer Inc.’s profit more than doubled in the second quarter, the company said. Pfizer reported revenues of $12.1 billion, an increase of 9 percent compared with $11.1 bil-lion Q2 2007. Due to the loss of United States exclusivity for Zyrtec and Camptosar, revenues in the United States fell 2 percent to $4.8 billion. However, international revenues were $7.4 billion, an increase of 18 percent. Restructuring and cost-reduction initiatives, the positive impact of foreign exchange and favorable income tax adjustments fueled a net income of $2.8 billion, an increase of 119 percent compared with $1.3 billion in Q2 2007. Pfizer CFO Frank D’Amelio said the compa-ny expects many of its cost-cutting measures will be realized during the second half of this year.

“Based on our year-to-date performance and outlook for the remainder of 2008, we are reaf-firming our full-year 2008 revenue and adjusted diluted EPS guidance as well as our plan to reduce absolute adjusted total costs by at least $1.5 to $2 billion at the end of 2008 com-pared with 2006 on a constant currency basis,” D’Amelio said.

Illumina on quarterly revenue growth streak

SAN DIEGO—Genetic analysis company Illumina Inc. boosted its third-quarter and full-year outlooks after reporting a 66 percent surge in product sales during the second quarter of 2008, the compa-ny’s twenty-eight consecutive quarter of revenue growth. Illumina reported revenue of $140.2 mil-lion, a 66 percent increase over the $84.5 million reported in Q2 2007 and a 15 percent increase over its first-quarter revenue of $121.9 million. Illumina’s net income on a non-GAAP basis for Q2 was $27.5 million, or $0.44 per diluted share, compared to $16.8 million, or $0.29 per diluted share, for Q2 2007. Illumina generated $37.2 million in cash flow from operations during Q2, compared to $24.5 million in Q2 2007. Illumina ended the quarter with $356.1 million in cash and investments, compared to $328.8 million as of March 30.

Illumina said it expects revenues between $142 and $147 million for the third quarter of 2008 between $550 and $560 million for the full year.

“By almost any measure, our quarter just com-pleted was the best in the company’s history,” said Illumina President and CEO Jay Flatley. “We have now recorded seven consecutive years of quarterly sequential revenue growth.”

Waters reports 13 percent sales growth in Q2

MILFORD, Mass.—Waters Corp. reported Q2 2008 sales of $399 million, an increase of 13 percent over sales of $353 million in Q2 2007. Foreign currency translation contributed 6 per-cent to this reported sales growth rate. On a GAAP basis, earnings per diluted share for the first quarter were $0.82, compared to $0.59 for Q2 2007. On a non-GAAP basis, exclud-ing purchased intangibles amortization in both periods and a cumulative adjustment relating to capitalized software amortization and related tax expenses, EPS grew 27 percent to $0.76 in Q2 2008 from $0.60 in Q2 2007.

“Though the first half of 2008 presented Waters with a challenging economic environment, solid sales of our technologically advanced systems solutions, as well as our recurring revenues, result-ed in strong earnings growth and superior cash generation,” said Douglas Berthiaume, Waters chairman, president and CEO.

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6 Drug Discovery News • August 2008 For more information, visit www.DrugDiscoveryNews.com

ZURICH, Switzerland—Immunomedics Inc. and Nycomed GmbH recently announced a license and collaboration agreement providing Nycomed a worldwide license to develop, manufacture and commercialize veltuzumab, Immunomedics’ humanized anti-CD20 antibody in a subcutaneous formulation for the treatment of all non-cancer indications.

Under the terms of the deal, Immunomedics will receive a non-refundable initial cash payment

of $40 million, subject to applicable Hart-Scott-Rodino Act approval, and could potentially earn milestone payments of up to $580 million upon completion of certain clinical, regulatory, and sales-based milestones. It also will receive escalat-ing double-digit royalties on sales of veltuzumab for the indications.

“Nycomed is the ideal partner for veltuzumab,” says Cynthia L. Sullivan, president and CEO of

Upstream Biosciences, McGill University to collaborate on tropical disease treatment testingVANCOUVER, British Columbia—Upstream Biosciences Inc. a n n o u n c e d i n Ju ly t h at i t entered a collaboration with McGill University’s Institute of Parasitology in Montreal to begin in vitro testing of the company’s second generation of drug candidates for the potential treatment of tropical diseases leishmaniasis, trypanaosomia-sis (African sleeping sickness) and malaria.

Joel L. Bellenson, CEO of Upstream, says, “The testing will evaluate the company’s second-generation drug can-didates for anti-parasite activ-ity and safety to human cells. McGill University is one of

OXFORD, U.K.—Summit Corp. plc and California-based BioMarin Pharmaceutical Inc. announced late last month they the com-p a n i e s i n ke d a n e xclu s ive worldwide licensing agreement for Summit’s novel preclini-

cal candidate SMT C1100 and all follow-on molecules, which are being developed to treat the fatal genetic disorder Duchenne muscular dystrophy (DMD).

Under the terms of the licens-ing agreement, Summit will

receive an upfront payment of $7 million in the form of an equity investment in Summit shares, future development and regulatory milestones totaling $51 million, tiered royalties ris-ing to the low teens, depending

on sales and product sales mile-stones, giving a total deal value of up to $143 million. The total expense to BioMarin in 2008 is expected to be approximately $1.8 million.

Summit will be responsible

for completing the preclini-cal development of SMT C1100, while BioMarin will be respon-sible for the clinical develop-ment, regulatory filing and com-mercialization of the product candidate.

“We are pleased to work with Summit on the Duchenne mus-cular dystrophy program,” says Jean-Jacques Bienaimé, CEO of BioMarin. “SMT C1100, an oral small molecule utrophin upregulator, has shown prom-ise in animal models of DMD and may have the potential for treating the entire spectrum of DMD patients, not just those with a particular type of muta-tion. The DMD indication aligns

Seattle Genetics, Daiichi Sankyo enter antibody-drug

conjugate collaboration BOTHELL, Wash.—Seattle Genetics announced last month it entered an exclusive, worldwide collaboration agreement with Daiichi Sankyo Co., Ltd. for the development of antibody-drug conjugates (ADCs) targeting a single antigen found on multiple types of solid tumors.

Under the terms of the collaboration, Seattle Genetics will receive an upfront payment of $4 million, progress-dependent milestone pay-ments and mid-single digit royalties on world-wide net sales of resulting ADC products. Daiichi Sankyo is responsible for research, product development, manufacturing and commercial-ization. Seattle Genetics will receive material supply and annual maintenance fees as well as research support payments for assistance.

Alnylam announces extension of collaboration with Novartis

CAMBRIDGE, Mass.—Alnylam Pharmaceuticals Inc. an RNAi therapeutics company, announced recently that Novartis has elected to extend the company’s RNAi therapeutics collaboration for an additional year, through October 2009. The alliance was initiated in October 2005 and is focused on the discovery, development and commercialization of RNAi therapeutics toward a defined number of Novartis-selected disease gene targets.

In the collaboration, both companies are jointly responsible for RNAi discovery activi-ties and Novartis is generally responsible for development and commercialization of RNAi therapeutic products. With the extension of the alliance term, Novartis will continue to fund collaboration research and development efforts conducted by Alnylam.

DNDi, Lafepe to deliver at-cost pediatric Chagas disease drug GENEVA, Switzerland—A new partnership between Lafepe and The Drugs for Neglected Diseases Iniative (DNDi), will make available the first pediatric formulation of benznidazole to patients by the end of 2009. The drug will be sold at cost, with no profit to the institutions involved in its development, and will be avail-able for distribution worldwide. Although ben-znidazole has been available since the 1970’s, until now there has been no formulation for pediatric use that meets the needs of children according to their ages and weights.

“The partnership between DNDi and Lafepe has responded to one of the most important priorities set by the international community for combating Chagas disease: the development of a pediatric formulation of benznidazole,” says Isabela Ribeiro, DNDi’s senior project manager in Brazil. “The current use of the adult treatment may put children with Chagas disease at risk.” tropicAl continued on page 9

summit continued on page 7

nycomed continued on page 9

Bayer HealthCare acquires Maxygen’s hemophilia assets for up to $120 million

By Amy swindermAn

LEVERKUSEN, Germany—In a deal worth up to $120 million, Bayer HealthCare last month acquired the hemophilia program assets of Maxygen Inc., a biopharmaceutical compa-ny focused on developing improved versions of protein drugs, as well as a license to use Maxygen’s MolecularBreeding technology, a novel research platform for exploiting gene targets.

According to Bayer, the acquisition will expand its commitment to hemophilia by adding MAXY-VII, Maxygen’s lead thera-peutic candidate for the treatment of hemo-philia, to its portfolio. The deal includes a license to use Maxygen’s MolecularBreeding technology for a broad set of genes in Bayer’s specialty pharmaceutical business. In addi-tion, Bayer receives exclusive rights to use the technology for 30 specified gene targets

in areas of strategic business interest. The total transaction is valued at $90 million upfront with a final, potential milestone payment of $30 million.

Mike Mathews, head of global strategic

marketing for Bayer’s hematology business, says MAXY-VII, a next-generation recom-binant Factor VIIa protein that is expected to enter Phase I clinical testing in the third

Stop the bleeding

Maxygen CEO Russell Howard says his company refocused its MAXY-VII efforts on its original indications for hemophilia, a change that has resulted in its current deal with Bayer.

mAxygen continued on page 7

Summit lands $143M license deal

“The DMD indication aligns well with our growing product development pipeline as it is a genetic disorder with no approved treatments. IND-enabling studies with SMT C1100 are underway, and we plan on entering the clinic in 2009.”—Jean-Jacques Bienaimé, CEO of BioMarin

tropical diseases tested

Immunomedics, Nycomed in veltuzumab deal

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Global NewsFor more information, visit www.DrugDiscoveryNews.com August 2008 • Drug Discovery News 7

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quarter of this year, has significant market potential. Roughly 20 percent to 30 percent of patients with hemophilia develop antibod-ies to current therapies. In these instances, a Factor VIIa is used to bypass inhibitors and help hemophiliacs to form clots.

“Today, the Factor VIIa market is esti-mated at about $1 billion,” Mathews says. “Developing a product that has the poten-tial to be superior to current offerings may provide patients with a better choice. We’re excited to bring this product candidate into our hemophilia portfolio.”

Bayer will not be the first pharma to house MAXY-VII in its portfolio. Previously, Maxygen co-developed the candidate with Roche Holding AG for the off-label treat-ment of acute bleeding conditions associ-ated with blunt trauma. But in early 2007, when the parties could not establish an ani-mal model intended to provide preclinical de-risking of the program, Roche gave it

back to Maxygen.“Roche did add a lot of value to the pro-

gram, but we turned on a dime and took a drug that had been developed for acute, off-label indications and went back to its original label indication for hemophilia,” says Maxygen CEO Russell Howard. “Bayer knows this territory very well, and the deal we have consummated will be the best one for hemophiliacs.”

Howard says Bayer’s resources will help Maxygen overcome some of MAXY-VII’s current deficiencies, namely its expense.

“There is clear competition in this mar-ket, but the hemophilia population doesn’t

use drugs like this as much as they could or should because of financial concerns,” Howard says. “Novo Nordisk sells one vial of its NovoSeven Coagulation Factor VIIa for $10,000, and the average hemophilia patient may need two to four of those doses per epi-sode. The possibility of expanding and mar-keting this drug is so expensive, especially in the United States, where healthcare is not uniform. We’re hoping Bayer will be able to expand this drug to give better coverage to people with this disease.”

Mathews adds that Maxygen’s Molecular Breeding technology provides Bayer with a larger library of novel variants in which to

discover protein therapeutics, increasing Bayer’s chances of discovering highly opti-mized, best-in-class molecules.

“Taking the example of MAXY-VII, it is possible that an improved version of FVIIa could have been derived using classical pro-tein engineering techniques, but by creat-ing all possible combinations of variants in this key region of FVIIa, the shuffling tech-nology led to the identification of what we believe is the most highly optimized variant. This was done in a timeframe that would not have been feasible with the standard tech-nologies,” Mathews says. ddn

editconnect: e080821

well with our growing product development pipeline as it is a genetic disorder with no approved treatments. IND-enabling stud-ies with SMT C1100 are underway, and we plan on entering the clinic in 2009. By lever-aging our expertise in rapidly developing and commercializing products for focused patient populations, we hope to soon pro-vide a new treatment option for all DMD patients.”

DMD is a fatal neuromuscular disorder that affects 1 in 3,500 boys with an esti-mated developed world patient popula-tion of more than 40,000. DMD is caused by a genetic defect whereby patients lack an important protein called dystrophin, which is crucial to maintaining muscle integrity and function. The absence of dys-trophin results in extensive muscle wast-ing in all voluntary muscles as well as the heart and breathing muscles and causes severe restriction in the mobility of DMD patients by their early teens and is ulti-mately fatal, generally in their twenties. Currently there is no cure for DMD; cor-ticosteroid treatment is the only frontline therapy and acts to only delay the progres-sion of the disease.

Steven Lee Ph.D., CEO of Summit notes, “BioMarin has an unparalleled track record in developing orphan drugs to market and has developed and launched successfully three such drugs in record time. The exper-tise and commitment of the BioMarin team gives me great confidence that they are an excellent partner for this program. I believe they will help to deliver SMT C1100 into a medicine in the shortest timeframe possible for the benefit of all DMD patients.

“For Summit, this deal is important as it is the first of many that we anticipate signing from our broad pipeline of assets including two clinical and two preclinical programs with future research driven by our world leadership in two innovative technology platforms.

“Our business strategy is focused on out-licensing or partnering candidates at a pre-clinical or early clinical stage, where there is a strong demand from pharma and biotech companies looking to enhance their own pipelines, and this deal provides important validation of this strategy,” Lee says. ddn

Global News8 Drug Discovery News • August 2008 For more information, visit www.DrugDiscoveryNews.com

ROCHEcontinued from page 1

based financial firm Robert W. Baird & Co., upped its target price from $89 per share to $95, which may be the minimum offer need-ed to get the deal done. Other analysts and published reports have suggested a price of as high as $102 to $105 per share might be what is needed to get the remaining share-holders to bite.

“The 8.8 percent is not a huge premi-um,” notes Baird analyst Christopher J. Raymond. “We didn’t write this in our note, but what may serve as a guide or a proxy for this is the Novartis-Chiron deal, where Novartis owned part of Chiron. There were different dynamics, but there were two or three different iterations [of the offer] and it eventually went for about a 30 percent premium.”

While Raymond doesn’t think Genentech should command that high a premium, investors have indicated they, too, antici-pate Roche coming back with a higher bid as shares of the biotech have consistently traded in the $94 to $96 range since Roche made its bid.

As expected, three days after the offer, Genentech formed a special committee of the Board of Directors—essentially the three board members without an affiliation to Roche—to review the offer by Roche.

“The special committee intends to pro-ceed in a timely manner to review the Roche proposal, which was both unsolicited and unexpected,” says Charles A. Sanders, the chairman of the three-person special com-mittee, which also includes Debra L. Reed and Charles A. Sanders, M.D. “The outcome of this process has not been pre-determined, and there can be no assurance that the spe-cial committee will approve any transaction with Roche.”

Meantime, Humer has been publicly beat-ing the drum of Roche’s plans to provide a broad amount of latitude in how it will oper-ate the Genentech site going forward. This is

not surprising, given the possibility that the South San Francisco Genentech headquar-ters could experience a significant brain drain should longtime Genentech employ-ees, known for their creative and innovative spirit, seek to recreate that environment by spinning off new companies in the fertile Bay Area biotech landscape.

“We will run Genentech’s research and early development as a separate, indepen-dent unit within Roche, thereby maintaining the spirit, the culture, the whole environ-ment of creativity, of diversity of approaches in research, which is necessary for that suc-cess,” notes Humer in a company-produced interview providing additional details of Roche’s offer.

The proposed deal is also not in the same vein as a mega merger between two unre-lated companies.

Roche Chairman Franz Humer says Roche intends to keep the South San Francisco, Calif. home of Genentech operating as an independent R&D division, should its plan to purchase the remaining shares it doesn’t already own go through.

“Don’t forget, we’ve owned for 18 years the majority of Genentech,” said Humer in an interview on cable financial news net-work CNBC. “So we are taking the company private. This is not a mega acquisition like others are.”

That said, there are a number of reasons why Roche is interested in acquiring the remainder of shares now. At the top of the list would be anticipated growth in the sales of Genentech’s successful cancer therapeutic Avastin, which is expected to be approved for additional indications in the coming years. Humel is quick to point out, though, this is not merely a play to leverage the growth of a successful product.

“This was not a decision that was driven by Avastin,” he says. “It was a decision that is driven by two components, strengthening the innovation for Roche and achieving syn-ergies where it makes sense.”

Further, Roche is looking to Genentech to

help it navigate what Humel sees as a very difficult market environment in the com-ing years, via Genentech’s strength in R&D, an area Baird’s Raymond calls “a national treasure” and “one of the premier in all of biopharm.”

The combination of the two operations is expected to result in between $750 million and $800 million in synergy savings accord-ing to Roche, yet another important factor as it looks to compete in an ever-tougher worldwide pharma market.

In another development, and perhaps in anticipation of eventually closing a deal for the remaining Genetech shares, Roche has announced its intention to close its Nutley, N.J. manufacturing operation and move its U.S headquarters to San Francisco. Roche has said it still intends to keep certain R&D and development functions in the Nutley location. ddn


BASEL, Switzerland—Roche and Madison, Wis.-based Mirus Biosciences Corp. announced the companies entered into a definitive agreement under which Roche will acquire Mirus, a company that focus-es on the discovery and development of innovative nucleic acid based technolo-gies, including a proprietary RNAi deliv-ery platform.

“The pioneering work in RNAi deliv-ery by the scientists at Mirus, together with our Centre of Excellence for RNAi research in Kulmbach, puts Roche at the forefront of bringing this whole new class of treatment to patients who suffer from difficult to treat diseases,” says Lee E. Babiss, global head of Roche Pharma Research. “Our global research team has made great strides in advanc-ing RNAi therapeutics, and with our new colleagues in Madison we will now bolster those efforts. The technology

brought by Mirus, together with addi-tional technologies, will bring us closer to creating fully enabled RNAi thera-peutics.”

Under the terms of the agreement, Roche will acquire Mirus for $125 mil-lion and will maintain an RNAi research site in Madison. Mirus’ transfection reagents business will be divested into a standalone business to be known as Mirus Bio LLC, without any anticipat-ed effect on existing customers. Closing of the transaction is subject to standard conditions and is expected during the second half of 2008.

“The expertise, resources and commit-ment that Roche brings to the RNAi field make Roche an ideal partner for Mirus,” says Russell R. Smestad, president of Mirus. “Together we will be able to great-ly accelerate the progress we would have accomplished independently.” ddn

Roche acquires RnAi company Mirus

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Canada’s leading universities, and its Institute of Parasitology is recognized internationally for its research into infectious para-sitic diseases.”

Upstream’s proprietary drug dis-covery platform utilizes chemoin-formatics which combines chem-istry and computer-aided design to accelerate the speed and reduce the cost of discovering drugs to treat disease.

Upstream’s first generation of drug candidates have successfully demonstrated in vitro anti-parasit-ic activity, in vitro human cell safe-ty, and in vivo (in animals) safety for leishmaniasis, trypanaoso-miasis and malaria. Management anticipates that the company’s fi rst generation drug candidates will undergo in vivo (in animals) effi-cacy testing before the end of the third quarter of 2008.

“We have designed our second generation of drug candidates based on the best-performing characteristics of our fi rst genera-tion drug candidates, which have now advanced into animal testing,” says Bellenson. “Our technology allows us to quickly and cheaply enhance our compounds to have fewer side-effects and to be more effective at lower dosages.”

Testing at McGill’s Institute of Parasitology, one of the few centers dedicated to investigating infrec-tious parasitic diseases, will be directed by Dr. Armando Jardim, who has published an extensive body of research covering the iden-tification and characterization of parasite drug targets, including leishmaniasis.

“New treatments are desper-ately needed for these tropical dis-eases which have become resistant to available therapies. Our test-ing will evaluate the potential of Upstream’s newest compounds,” says Jardim. ddn

TROPICALcontinued from page 6

Immunomedics. “We believe their new research and development strategy that focuses on target areas outside of the fi eld of oncol-ogy means that Nycomed will vig-orously develop the full potential of veltuzumab in the fi eld of autoim-mune and infl ammatory diseases.”

Nycomed will develop veltuzum-ab in rheumatoid arthritis (RA) as the primary indication. Anti-CD20 antibodies are considered to be a

growing segments within the RA market and offer additional poten-tial by extending into other auto-immune and infl ammatory diseas-es. The agreement also provides Immunomedics with an option to co-promote veltuzumab for immune thrombocytopenic pur-pura (ITP), an autoimmune disease treated by the same physician spe-cialtist who treats blood cancers such as non-Hodgkin’s lymphoma.

If Immunomedics exercises its option, it will have sole responsi-bility for sales calls for ITP in the

United States. Profits from these sales will be shared based on a pre-arranged percentage allocation.

“This alliance with Immuno-medics is a significant step for Nycomed to extend its network with leading biopharmaceutical companies. Nycomed strength-ens its clinical pipeline and veltu-zumab offers an excellent strate-

gic fit with Nycomed’s other pro-grams in the field of autoimmune and inflammatory diseases,” says Hakan Bjorklund, Nycomed’s CEO. “Within the growing market of anti-CD20s in the autoimmune area, we believe that veltuzumab differenti-ates and can offer signifi cant medi-cal benefit through its subcutane-ous application route.” ddn

NyCOMEDcontinued from page 6

Nycomed strengthens its clinical pipeline and veltuzumab offers an excellent strategic fi t with Nycomed’s other programs in the fi eld of autoimmune and infl ammatory diseases.”—Hakan Bjorklund, CEO, Nycomed

Biomax, The Mount Desert Island Biological Laboratory collaborateMARTINSRIED, Germany—Biomax Informatics and the Mount Desert Island Biological Laboratory announced Biomax will integrate MDI’s Comparative Toxicogenomics Database (CTD) into the BioXM Knowledge Management Environment. CTD is a manually curated resource, which aids understanding the effects of environmental chemicals on human health. Biomax will offer CTD as a free resource to all users of Biomax’s enterprise platform for semantic data integration, the BioXM system.

CTD includes cross-species chem-ical–gene/protein interactions and chemical– and gene–disease relation-ships to elucidate molecular mecha-nisms underlying variable susceptibility and environmentally influenced dis-eases. These relationships complement the semantic network created by the Biomax Oncology Base.

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editorial10 Drug Discovery News • August 2008 For more information, visit www.DrugDiscoveryNews.com

By stephen AlBAiny-Jenei

At the beginning of the last cen-tury, the majority of drug products available were ineffective for their stated purpose at best and did more

harm at worst. it is noteworthy that for many of these so-called Patent Medicines, the main active ingredient was alcohol—often 30 percent or more.

Since 1962, before a new drug can be mar-keted in the United States, the food and Drug Administration (fDA) must approve it, after it is shown to be safe and effective. this, also, has not been without side effects since it means that

a company must complete clinical trials, which increases the cost of developing new drugs and delays their introduction.

one way drug companies are compensated for the regulatory burden is the extension of patent terms. in the United States, the Drug Price Competition and Patent term Restoration Act of 1984 (hatch-Waxman Act) makes it pos-

sible for drug patentees to have the term of their patent extended for as much as five years if they meet certain criteria. in the eU, there is the Supplementary Protection Certificate (SPC).

A m i d st t h i s b ackd r o p , a l o n g c o m e s AstraZeneca with an application for a patent term extension of the patent term of U.S. Patent no. 5,674,860, based the time for fDA review of Symbicort.

the Patent office determined that the ‘860 patent was ineligible for patent term extension based upon the regu-latory review period because (1) Symbicort does not constitute the first permitted commercial marketing or use of the product Symbicort under the provision of law under which such regulatory review period occurred, and (2) the Pte Application was not timely filed.

based on this statutory language, one of the eligibility requirements for a patent term exten-sion is that the permission for the commer-cial marketing or use of the product be the first permitted commercial marketing or use of the product. the term product is defined as a single entity or in combination with another active ingredient.

in this case, AstraZeneca indicated that Symbicort contains two active ingredients: for-

moterol fumarate dihydrate and budesonide, both of which were approved for commer-cial marketing or use before the approval of Symbicort. AstraZeneca argued that since the product Symbicort is a synergistic combination of formoterol fumarate dihydrate and budes-onide, it should be considered as a single active ingredient for patent term extension purposes.

the Patent office begged to differ, stating that the synergistic effect of the active ingredi-ents formoterol fumarate dihydrate and budes-onide has no relevance in determining “first permitted commercial marketing or use of the product.”

Since the term product includes any new drug or antibiotic drug “as a single entity or in combination with another active ingredient” the court found that synergistic effects are not an appropriate distinction for term extension policies.

AstraZeneca could appeal.[Side note: Some consumer products were

once marketed as patent medicines but have been reformulated and are no longer sold for medicinal purposes. their original ingredients may have been changed to remove drugs; such is the case with Coca-Cola. others, like Vicks VapoRub still exist. ddn

Stephen Albainy-Jenei is a patent attorney at Frost

Brown Todd LLC, serving up chat at PatentBaristas.com.

Feel free to write him with comments or questions at

mailto:[email protected]. Stephen doesn’t

own shares of any company mentioned in this article.

i’Ve liVeD in My hoUSe for seven years, so i have a pretty good feel for how long seven years is. Seven years ago, my daugh-ter still believed in the tooth fairy and we

had a gate across the top stairs of our deck to prevent my toddler son from tumbling down. today, my daughter is getting ready for high school and my son plays little league baseball. in 2015, my daughter will be 22 and ready to start life on her own. My son will be nearing the end of high school. Suddenly, the future doesn’t seem so far away.

And that, perhaps, is how the management at Roche began to feel about its longtime relation-ship with superstar biotech genentech. Seven years ago, genentech shares were trading for roughly $22 per share and Roche had been the majority owner of the company for a bit more than 10 years. in 2001, with agreements in place that would provide Roche with first choice to pick genentech’s ripest fruit, i’m sure 2015 seemed forever in the future.

but not anymore. like most of the big pharma companies, Roche, though very well run, has to

be apprehensive about the future. Chairman franz humer, in recent interviews, has com-mented on how challenging he expects the mar-ket will be for companies such as his, which are faced with what should be a very different industry over the next 20 years.

gone are the days of big pharma riding a couple of bucking bronco blockbusters to prof-itability, with foals already lining up to replace

the current horses when they get worn out—or their patents expire.

Which brings us back to Roche and genentech. the sheer size of the companies involved, and the majority ownership by Roche, make this unlike other deals. Roche has not been referring to its offer of $43.7 billion for the remaining shares as an acquisition—and technically, anyway, that would be correct. but i’m sure it doesn’t feel that way in South San francisco.

And it doesn’t look that way from the out-side looking in. if this is all lovey-dovey and merely “taking genentech private” as humer has noted, why does this look more like a takeover? Maybe it’s because, as has been reported in the media, genentech Ceo Arthur levinson had it sprung on him via an evening phone call the day before Roche

went public with its offer.And once it went public, Roche

began taking hits for making what many called a low-ball offer for the remaining shares. the mar-ket certainly expects more and as

the price of genentech still sits around $95 per share as i write this—seven percent more than Roche’s $89 per share offer—and it appears the market is actually demanding more.

After all, it is hard to imagine the three-per-son special committee of genentech sending the white smoke up the chimney and emerging to say “we have a deal” at less than market.

Which also makes a recent lawsuit filed by an

intentionally unnamed law firm against Roche and various genentech executives all the more laughable. After all, no one has bought or sold anything yet. i could go on for hours about folks taking personal responsibility for their invest-ment decisions, including knowing that Roche is a majority holder and that taking full owner-ship is a distinct possibility, but i guess some people just need someone to blame.

this deal is nothing more than what happens in those $43.7 million deals, where a big pharma company buys the up-and-coming biotech for its innovative technology. genentech is argu-ably the model of innovation in the industry and it is hard to argue with the success the com-pany has achieved.

Sure, Roche has benefited greatly from its ownership stake, but right now what it really wants is innovation—and in genentech, it can get that in spades. it also wants to keep the abil-ity to grab genetech’s ripest fruit, something that could disappear in seven years if it doesn’t act to preserve that.

Consensus seems to be that this deal will get done, at a price higher than the initial offer, and that this shouldn’t drag out as did Roche’s recent acquisition of Ventana Medical Systems.

With the Swiss franc strong against the dol-lar, and for the above reasons, now was the time for Roche to act on what it surely has been contemplating for some time. it’s a good move and a smart move. Roche has promised to allow genentech broad latitude in its research opera-tions should the deal eventually go through. that too is a good move.

So while we wait for the answers to the ques-tions of how much will Roche pay and when, the real elephant in the room is a question that can only be answered in time: Will it work? ddn

How soon does 2015 seem to you?

Chris Anderson,Chief Editor

Synergy won’t get you a patent term extension

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Stephen Albainy-Jenei,Frost Brown Todd LLC

ONE wAy drUG COMPANiES are compensated for the regulatory burden is the extension of patent terms. in the United States, the drug Price Competition and Patent Term restoration Act of 1984 (Hatch-waxman Act) makes it possible for drug patentees to have the term of their patent extended for as much as five years if they meet certain criteria.

rOCHE HAS NOT BEEN referring to its offer of $43.7 billion for the remaining shares as an acquisition— and technically, anyway, that would be correct. But i’m sure it doesn’t feel that way in South San Francisco.

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Sophic and Biomax receive funds to complete NCI’s Cancer Gene Index ProjectBy Amy SwindermAn

EAST FALMOUTH, Mass.—After five years of text mining and manual annotation, Sophic Systems Alliance Inc. has launched the final phase that will complete the National Cancer Institute’s (NCI) Cancer Gene Index Project, a highly curated, standardized and comput-able cancer knowledge base.

Sophic, which teamed up with Biomax Informatics AG in Munich, Germany, to work on the pilot phase of the project in 2004, has received $1.3 million from the NCI to complete the project by May 2009. The NCI has funded the project in whole, or in part, with federal funds. When complete,

the cancer community will have access to 6,610 cancer-related genes found in Medline abstracts, with manually annotated gene-disease and gene-compound relationships.

“This knowledge base is the foundation for reliable, accurate cancer research for all types of cancer diseases, clinical trials, bio-markers and much more,” says Sophic CEO

Pat Blake, project manager for the index. “The NCI has been great to work with, and this has been a real team effort to complete the collaboration. Sophic and Biomax appre-ciate the opportunity to provide the cancer community with this asset.”

The NCI tapped East Falmouth, Mass.-

Finding the needle in the haystack

NO GENE LEFT BEHIND

Thermo Fisher and Genedata form mass spec partnershipBy Amy SwindermAn

SAN JOSE, Calif.—As mass spec-trometry (MS) continues to change the way metabolomics research is conducted, research-ers are finding it difficult to manage mass quantities of high-resolution data. Seeking to enable scientists to more efficiently process and analyze hundreds of gigabytes of data, Thermo Fisher Scientific Inc. and Genedata announced July 18 the integration of Thermo

Scientific’s MS instrumentation and Genedata Expressionist, a modular computational plat-form for biomarker discovery

that performs high-throughput processing and automated qual-ity analysis of MS-based metab-

indeX continued on page 13

Entelos granted patent for liver toxicity screening test

FOSTER CITY, Calif.—The U.S. Patent and Trademark Office has granted Entelos Inc. a patent for its Cholestasis Signature database, a gene expression test for liver toxicity screen-ing. The biomarker set is one of dozens from Entelos’ proprietary library of Drug Signatures, which have been derived from DrugMatrix, a reference database linking gene expression profiles of over 630 drugs to results from tra-ditional preclinical pharmacology, safety and toxicity tests.

“Drug failures are often due to unwanted side effects in the liver, and DrugMatrix is used by our pharmaceutical customers to rapidly prioritize compound portfolios and minimize or eliminate these liabilities much earlier in their R&D process,” says Entelos President and CEO James Karis.

Galapagos opens predictive databases to European researchers

MECHELEN, Belgium—Galapagos NV has made its predictive drug discovery data-bases publicly available online to the EMBL’s European Bioinformatics Institute. Galapagos will receive €1.8 million in cash for the license, which was funded under a grant from the Wellcome Trust, the largest charity in the United Kingdom. The agreement involves a suite of databases for novel drug target selection, including DrugStore, a database of known drugs, StARLITe, a database of known compounds and their effects, Strudle, binding site drugability, and Kinase SARfari and GPCR SARfari, informatics systems for widely used target classes in drug discovery.

Ariana Pharma raises private funds to enhance data

mining platformPARIS—Self-funded until now, Ariana Pharma, a bioinformatics decision support company, has raised a11.5 million through a private placement to further develop its decision sup-port tools, strengthen sales and add functional-ity to its lead product, the Knowledge Extraction and Management (KEM) data mining platform. The sole investor was Vizille Capital Innovation, which takes a minority stake alongside existing shareholders, the Institut Pasteur and company management. According to Ariana, changes to the KEM platform will enhance its use in clini-cal trials and drug safety domains, interfacing with current industry standards and providing the new ability to detect early signals.

Headquartered in Paris, Ariana has licensing agreements with some of the largest pharma-ceutical and biotechnology companies, includ-ing Pfizer, GSK, Novartis and Lundbeck.

Channing Lab phases out Legacy LIMS with LabVantage’s SAPPHIRE By Amy SwindermAn

BOSTON—Seeking a cus-t o m i z ab l e, We b - b a s e d biorepository management solution for its internal and external researchers, the prestigious Channing Laboratory has licensed L ab Va nt a ge S o l u t i o n s Inc.’s Sapphire BioBanking Solution to replace its 10-year-old LIMS system.

A s p a r t o f a m u l t i -phase laboratory informa-tion management project, LabVantage will deploy Sapphire in the Respiratory Epidemiology Genotyping Laboratory, replacing sig-nificant portions of the LIMS and software pack-ages developed by the Channing Laboratory more than a decade ago.

Dr. Scott Weiss, prin-cipal investigator for the Channing Laboratory, a multidisciplinary research

OUT WITH THE OLD

CHAnninG continued on page 13

mASS SpeC continued on page 14

gSK, univ. of Manchester ally to bridge research gaps in u.K.By Amy SwindermAn

LONDON—Seeking to bolster drug discovery efforts within their own walls as well across the U.K., British pharma GlaxoSmithKline and England’s University of Manchester have formed a research alliance that will accelerate their existing research partnerships and eliminate experimental and transitional hurdles for their compatriots.

With a common focus on translational or “bench to bedside” medical research, the two orga-nizations hope to leverage GSK’s drug discovery expertise and build on the university’s strong base in bioscience to accelerate their own research efforts, combine research funding bid approaches,

bypass research obstacles and identify areas of pro-competitive research for the British pharma-ceutical industry.

British bioscience booster shot

“This really is a case where for the first time, the automation of high-throughput biomarker discovery in the field of metabolomics is possible.” —Jens Hoefkens, Genedata Managing Director

BriTiSH continued on page 14

The partnership between the University of Manchester, pictured above, and GSK is expected to benefit the two organizations as well as bridge research gaps in the British pharma industry.

“The feedback we have been getting is that this type of high-quality curation is going to become a very strong foundation for all steps of every part of cancer research.”—Pat Blake, Sophic CEO

For more information, visit www.DrugDiscoveryNews.com AUGUST 2008 • Drug Discovery News 13informatics

SciFiDrugDscNews2008.fh10 1/18/08 3:08 PM Page 1

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based Sophic to mine 8.8 million Medline abstracts to identify sus-pect cancer genes, manually verify true cancer genes and manually annotate role codes and evidence codes for 1,000 cancer genes select-ed by NCI. In order to manage the volume of material to review and organize the complexity of the information for the scientists, Sophic and Biomax CEO Dr. Klaus Heumann developed a “factory

assembly line” methodology that allowed the automated text mining results to be fed to the scientific team, which curated and annotat-ed the information in an efficient, quality-controlled workflow pro-cess.

NCI’s Thesaurus was lever-aged by Biomax’s BioLT Linguistic Tool to create extended diction-aries used to mine the literature. Scientist curators have manually verified all true cancer genes and have used controlled vocabularies to annotate and assign role codes

and evidence codes to each gene. One thousand of the true cancer

genes selected by NCI were manu-ally annotated and delivered to NCI in October 2004. From 2005 to 2007, three additional phases of the project were performed, each building on results and les-sons learned in previous phases. To date, the scientists have anno-tated 4,658 cancer genes, which are already publicly available.

“The hallmark of our instruc-tions from the NCI since the beginning has been, ‘not to miss

anything,’” Blake says. “The feed-back we have been getting is that this type of high-quality curation is going to become a very strong foundation for all steps of every part of cancer research.”

An index this robust is so valu-able, Sophic is in discussions with major hospitals to develop simi-lar libraries for complex diseases, Blake says.

“If you can do something this meaningful for something as complex and terrible as cancer, why not extend that capability to

thrombosis or other complex dis-eases related to cancer?” he says. “This process is going to have the most value for diseases that have huge complexities from a cellu-lar and molecular point of view. Our strategy is to work with doc-tors and researchers to identify where the tools and annotation factory assembly line methodol-ogy developed by Klaus and his team can most effectively be used for research associated with com-plex disease.” ddn

ediTConneCT: e080805

INDEXcontinued froM page 12

division of Brigham and Women’s Hospital and Harvard Medical School, says the lab has many external sites that did not exist when it built its internal fat-client system, and the scientists need a solution that allows them to share information across platforms. Although the project is not enter-prise-wide in scale, its success in the Respiratory Epidemiology Genotyping Lab may lead to other Channing groups deploying the solution.

According to Weiss, Sapphire was chosen for its configurable-off-the-shelf functionality and ability to integrate with the labora-tory’s existing systems.

“We needed a solution that would provide state-of-the-art biorepository management and that would also replace our legacy systems with standardized solu-tions,” Weiss says. “LabVantage’s Sapphire provides both, enabling us to deploy now and extend the solution in the future.”

Sapphire will map the laborato-ry’s existing processes to its built-in workflow management capa-bilities, automating the lab’s study management, sample collection, accessioning and storage manage-ment practices and ensure compli-ance with its standard operating procedures, Weiss says.

“The biggest benefit to us will be the ability to integrate with other LIMS systems that we use for QC in genotyping,” he says. “This will also reduce costs when it comes to integrating two informatics sys-tems, making our laboratory more efficient.”

Ron Kasner, vice president o f C o r p o r a t e D e v e l o p m e n t a t B r i d g e w a t e r, N. J. - b a s e d LabVantage, says the Channing Laboratory’s selection of Sapphire validates it as “a best-in-class sam-ple and biorepository management solution.”

“For organizations that do a lot of work internationally, the ability to securely access a system via a Web browser is critical,” Kasner says. “We have the ability to tai-lor our solution to meet the needs of our customer. We’re hoping to continue to expand our footprint within this organization.” ddn


CHANNINgcontinued froM page 12


informatics14 Drug Discovery News • AUGUST 2008 For more information, visit www.DrugDiscoveryNews.com

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TaqMan is a 384-well micro fluidic card designed for use with Applied Bio’s 7900HT Fast Real-Time PCR System to perform hundreds of real-time PCR reactions simul-taneously. TaqMan Custom arrays can be designed to a researcher’s specifications using any of Applied Bio’s 50,000 invento-ried TaqMan Gene Expression Assays and nine array formats.

StatMiner provides quantification analy-sis of gene expression data through a combi-nation of interactive visualization, advanced statistics and data mining tools. Real-Time StatMiner Software, which also enhanc-es quality assurance and quality control, ensures accurate differential expression results from large datasets and multiple endogenous control genes. A stand-alone

application, StatMiner is also available as an integrated guide within other leading laboratory data analysis systems.

Novartis, which is leading an initiative to promote the use of gene expression bio-markers in drug development studies, feels the most striking feature of the integration is the ability to analyze raw data as soon as it becomes available, according to Dr. Olivier Grenet, head of the Molecular Biology group at Novartis Investigative Toxicology.

“If there are any outliers in the analysis, they can be easily identified and they no longer interfere with the biological interpre-tation of data,” Grenet says.

Xavier Cristina, Applied Bio’s European manager for business development in functional analysis, says the solution is the first product including sophisticated algo-rithms for real-time PCR data analysis from Bioconductor containers.

“It will help the use of gene expression data by real-time PCR in regulated environ-ments like clinical trials for drug develop-ment,” Cristina says. “Without such data analysis, data may not be acceptable by FDA if used for drug submission.”

Integromics Commercial Director Imad Yassin says working with Novartis on the solution has enriched Integromics’ knowl-edge of researchers’ needs for high-through-

put analysis.“We believe in building solutions through

collaborations,” Yassin says. “This solution was driven by the fact that Novartis’ clients have always been adamant about the need for high-throughput analysis, and Novartis provided a blueprint of what this solution should look like. The Real-Time StatMiner application is now able to accommodate both large and small-scale projects, while continuing to deliver high quality results in all cases.” ddn


olomics and proteomics data. Thermo Fisher and Genedata will co-market the integrated solution, which the two companies say will help researchers to understand small mol-ecule biomarker detection in a single, com-prehensive system. Financial terms of the partnership were not released.

Iain Mylchreest, vice president of Thermo Fisher Life Sciences Mass Spectrometry, says the partnership is in line with Thermo Fisher’s strategy of seeking software devel-opment companies to complement its MS platform in emerging markets.

“We were looking for a scalable system that would take a researcher all the way from the work station to an enterprise-based station,” Mylchreest says. “We wanted to be able to customize how researchers acquire, process and analyze data and give us an open architecture system in which to play in the emerging market.”

Genedata Managing Director Jens

Hoefkens says the two companies have been talking for a few years about joining forces to allow their customers to produce and pro-cess large quantities of high-quality data.

“MS-based research has been reduced to finding a needle in a haystack,” Hoefkens says. “Thermo Fisher’s mass spec instru-mentation allows their customers to produce a lot of good quality data very quickly, but their customers were almost overwhelmed by the sheer amount of data produced. For the last five years, Genedata has been work-ing on extending our Expressionist product into the area of analysis and mining mass spec data. That’s where we came into play.”

Genedata Expressionist represents a single-point-of-access for all experimental data, including sample information, raw and pre-processed data, analysis results and documentation with reports. This allows researchers to process hundreds of giga-bytes of data simultaneously. Expressionist also includes a statistical analysis platform for data comparison.

Thermo Fisher expects the integrated

solution to have a marked impact on attri-tion rates, Mylchreest says.

“In the field of metabolomics research, there is not just a speed issue, but a con-fidence issue,” Mylchreest says. “One of the biggest challenges in drug discovery is trying to get attrition rates down. The goal here is to provide researchers with both the instrumentation that can give them high confidence in their data and the software to very quickly give them a complete picture of what is changing in the biological system.”

Hoefkens says the partnership is “really only the beginning,” and Genedata would like to see Expressionist support more than just Thermo Fisher’s proteomics instrumen-tation.

“This really is a case where for the first time, the automation of high-throughput biomarker discovery in the field of metabo-lomics is possible,” Hoefkens says. “While this part of our collaboration is focused on proteomics, we’d also like to extend our efforts to other providers.” ddn


GSK and the University of Manchester have collaborated substantially in the past, with a concentration on respiratory medi-cine, systems biology, gastrointestinal medi-cine and inflammation. With the new alli-ance, the two parties will focus initially on inflammatory processes and then pursue research methodologies such as systems biology and biomedical imaging and treat-ment areas such as respiratory disease, says Dr. Mike Musialowski, business develop-ment manager in the university’s Faculty of

your key to additional story contentAT THe end of every bylined story in DDN, you’ll find an Editconnect code, like the one in the Novartis story above: E080804.

Each code is your portal to addi-t i o n a l c o n t e n t f o r o u r s t o r i e s and is found on our Web site at www.drugdiscoverynews.com.

Simply click the Editconnect button on our home page, enter the code and access our story archives.

DDN Editconnect:

BRITISHcontinued froM page 12

MASS SPECcontinued froM page 12

Medical and Human Sciences.“ It i s a nt i c ip at e d t h at a st r at e g i c

approach, encompassing the complemen-tary research strengths of GSK and the uni-versity, will be synergistic in its research outcomes,” Musialowski says. “The initial area for concerted alliance activity is likely to be in the area of inflammatory processes. There exists an opportunity within this area to combine the university’s experience in solving fundamental questions in the mechanisms of inflammation with GSK’s strength in identifying and understanding therapeutic targets. This combination is expected to substantially accelerate prog-ress in this area.”

GSK declined to comment on the research alliance. Patrick Valliance, senior vice presi-dent for Discovery Research, said in a state-ment that the partnership will formalize GSK’s link with the university, which has invested heavily in its scientific capabilities in recent years. GSK funding of universi-ty research activity frequently exceeds £3

million in total research funding at any one time, according to the university.

“It is now a world-class institution, with first-rate biomedical science capabilities of the caliber that GSK welcomes forming an alliance with,” Valliance said in a statement.

The collaboration seeks to help bypass current experimental and translational hur-dles, Musialowski says.

“A closer working relationship with a glob-al leader in pharmaceutical research enables the University of Manchester to take a better informed view of issues affecting transla-tional research in medicine,” Musialowski says. “The link between GSK and one of the UK’s leading collaborative universities will result in an easier day-to-day exchange of knowledge and ideas.”

Ultimately, the partnership will also be a key factor in facilitating greater access to industry-sponsored research initiatives, Musialowski says.

“Working closely with GSK will be of critical benefit to those researchers seeking to make difficult translational steps in their healthcare research programs, ultimately driving the benefits of basic research closer

to solutions for the patient,” he says. “It is also anticipated that close cooperation will help bridge the skills gaps that exist within the UK industry base, given GSK’s expertise in drug development and the university’s strong base in basic bioscience, and influ-ence the development of new and ambitious research programs.” ddn


THE UnIvErSITy Of MAnCHESTEr AnD GSK will work to bridge skills gaps in the British pharma industry, according to Dr. Mike Musialowski, business development manager in the university’s faculty of Medical and Human Sciences.

NOVARTIScontinued froM page 1



automation & instrumentation

b r i e f s

16 Drug Discovery News • August 2008 For more information, visit www.DrugDiscoveryNews.com

Qiagen buys Australia’s Corbett Life Sciences in deal that could eventually top $130 million By Chris Anderson

VENLO, The Netherlands—In early July, Qiagen N.V. announced it had purchased Corbett Life Sciences, a Syndey Australia-based developer and distribu-tor of life sciences instrumentation for $66 million in cash, $4 million in restricted Qiagen common stock and performance and development milestone payments and other contingencies of up to approx-imately $65 million over the next four years.

At the heart of the deal are Corbett’s rotary real-time polymerase chain reaction (PCR) cycler sys-tem the Rotor-Gene and its accompanying CAS 1200 liquid handling system designed to automate the setup of quantitative real-time PCRs.

According to Ulrich Shriek, Qiagen’s VP of cor-porate business development, the company has been looking for some time to either develop in-house, OEM or purchase outright, detection tech-nologies to fill a gap in its line. Qiagen was already strong in developing reagents and assays for a number of different PCR tools including those

IonGate taps Artel to spearhead adoption and application of SURFE²R technology in North AmericaBy Chris Anderson

WESTBROOK, Maine—Less than six months after it announced the opening of its first sales office in North America, Frankfurt, G e r m a n y - b a s e d I o n G a t e Biosciences GmbH announced it is teaming with Maine-based liquid handling company Artel

to leverage Artel ’s market knowledge and its sales and ser-vice expertise to help broaden adoption of IonGate’s SURFE²R technology in the United States and Canada.

IonGate’s SURFE²R tech-nology enables more effective research involving drug targets such as membrane transporters and ligand-gated ion channels. According to Wolfgang Lerch, managing director of IonGate and president of the U.S. opera-tion, the label-free technology can provide researchers with

a high-throughput tool for use both in screening and in per-forming ADME studies.

“What the technology does is measure transport activity in the membrane cells and it does this label free,” says Lerch. “Until now there hasn’t been any technology that could do this in high-throughput. There is no other method that measures the transporters label-free which provides results that are more biologically relevant.”

Since SURFE²R is a relatively

Thermo Fisher buys Open Biosystems and adds company’s shRNA lentiviral library to its growing RNAi portfolioBy Chris Anderson

HUNTSVILLE, Ala.—With an eye toward preserving, if not strengthening, the open access principles that have guided Open Biosystems since its founding in 2001, Thermo Fisher Scientific announced in early July its purchase of the company, best known for its short-hairpin RNA (shRNA) and antibody libraries and tools aimed at the genomic research market.

Troy Moore, a founder and former CSO of Open Bio and now director of virology with Thermo Fisher, says aligning with Thermo Fisher will allow the company to take the next step forward to reaching a broader market for its products and services.

“From day one this was the most likely path that we would take,” Moore says. “This is a common path for many companies that need more money. We continued to plow the

money back into R&D and we could have made the decision to pace ourselves and [make it] a 10- or 15-year kind of endeavor. Or we can do what we did and find a partner who can get us there faster.”

With Thermo Fisher, Open Bio has sure-ly aligned itself with the biggest dog in the fight, but that was not a leading factor in deciding to sell to the company, which was among many suitors for Open Biosystems.

“The number one concern for us was that

a company embraces our open source biol-ogy model,” Moore adds. “Of all the groups we talked to about this, Thermo Fisher clearly showed us that is was more than just talk and they saw us as a strategic fit.”

One strong argument in Thermo Fisher’s favor to show it was serious about Open Biosystems’ model, was the similar-ity between Open Bio’s Open Access pro-gram and Thermo Fisher’s Global RNAi

Affinity for acquisitionsThermo Fisher buys Affinity BioReagentsBy Chris Anderson

WALTHAM, Mass.—Thermo Fisher announced last m o n t h i t s a c q u i s i t i o n of Golden, Colo.-based A f f i n i t y B i o R e a g e n t s (ABR), a provider of anti-bodies, peptides, proteins and other reagents for life science research. The pur-chase price for ABR, which had revenue of $6 million in 2007, was not disclosed.

“We see this deal as important in two ways,” says Chris Budde general m a n age r w it h Th e r m o Fisher. “First, the primary antibodies from ABR were an important addition for us and second, it repre-sents an opportunity for us to incorporate many of their products in our own internal product develop-ment.”

Affinity BioReagents has a broad offering of more than 35,000 reagents—pri-

Seegene, Shimadzu to develop combined PCR solution

ROCKVILLE, Md.—Seegene Inc. and Shimadzu Corp. recently announced a strategic partnership to combine Seegene’s Seeplex multi-pathogen tests with Shimadzu’s MultiNA analytical plat-form. Under terms of the deal, Shimadzu and Seegene will collaborate on integrating the Seeplex polymerase chain reaction-based tests with Shimadzu’s MultiNA high-speed electro-phoresis system to provide a highly sensitive, high-throughput multi-pathogen detection and analysis solution.

“This strategic agreement reinforces our plan to bring solutions, and not only products, to our customers,” said Dr. Jong-Yoon Chun, founder and chief executive officer, Seegene. “Shimadzu’s MultiNA is outstanding in the market for electrophoresis analysis and a perfect match for the Seeplex family of multi-pathogen tests.”

Accuri completes $13 million Series C financing

ANN ARBOR, Mich.—Accuri Cytometers Inc., a developer of bench-top flow cytometer systems, announced late last month the completion of a $13 million Series C financing led by Fidelity Biosciences and Flagship Ventures. Current investors including Baird Venture Partners and Arboretum Ventures also participated in the financing. Accuri will use the proceeds from the Series C financing primarily to expand its commercialization activities for the Accuri C6 Flow Cytometer System.

Explicitly designed for routine use by bio-medical researchers in their own labs, Accuri’s flow cytometer system is a full-featured bench-top cell analysis system that provides capabili-ties similar to industry-leading flow cytometers in a more user-friendly format and at a fraction of the cost.

Expression Analysis collaborates with the

Immunological Genome ProjectDURHAM, N.C.—Expression Analysis Inc., a pro-vider of genomic services for clinical trails and research, announced it entered into a scientific collaboration with The Immunological Genome Project to provide microarray expression profil-ing services for this NIH funded project.

The project will generate a complete microarray dissection of gene expression in the immune system of the mouse. The focus is on primary cells ex vivo, which will be analyzed through different states of maturation, innate or adaptive immune responses, effector stages and different tissue localization. Dr. Christophe Benoist, PI for the project, says, “We approached Expression Analysis because of their reputation in the market. We look forward to an exciting collaboration in this important endeavor.” ABr Continued on pAge 17

qiAgen Continued on pAge 18

open Bio Continued on pAge 17

Artel Continued on pAge 18

Short-hAirpin, long viewOPEN SOURCE: Since its founding in 2001, Open Biosystems has prided itself on its model of open access to its technologies for academic researchers. When it came time to sell, it wanted a partner that would honor the tradition, and found it in industry heavyweight Thermo Fisher.

IONGATE’S SURFE²R IS UP

Paying the price for PCR

For more information, visit www.DrugDiscoveryNews.com August 2008 • Drug Discovery News 17automation & instrumentation

www.invitrogen.com

©2008 Invitrogen Corporation. All rights reserved. These products may be covered by one or more Limited Use Label Licenses (see Invitrogen catalog or www.invitrogen.com). By use of these products you accept the terms and conditions of all applicable Limited Use Label Licenses. For research use only. Not intended for any animal or human therapeutic or diagnostic use, unless otherwise stated. A-077836-r1 0708

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The Jak/Stat pathway plays a critical role in the signaling of a wide array of cytokines and

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Figure 2—Analysis of key phosphorylation events in the regulation of the Jak/Stat pathway using multiple assay platforms. (A) phosphoELISA™ assays and (B) CellSen-sor™ cell lines were used to monitor STAT3 [pY705] phosphorylation following growth factor–induced (IL-6) stimulation or small-molecule inhibition (e.g., pyridone 6) of the Jak/Stat pathway in ME180 SIE-bla cells. (C) Using the Luminex® platform to multiplex numerous target proteins in a single assay, the phos-phorylation state of STAT1, STAT3, and STAT5 was analyzed in TF-1 cells following stimulation of spe-ci�c cytokines. (D) The LanthaScreen™ kinase assay was used to analyze the e�ect of various inhibitors on JAK1 kinase activity.

Your path to performanceAnalytical tools to dissect the Jak/Stat pathway

Figure 1—The Jak/Stat signaling pathway.

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Initiative—efforts in which each company has set up formal pro-grams for the open sharing of research results among scientists in research institutes and aca-demia.

“We work with academia and non-profits that are doing whole-genome screening to establish a community among the leading screening institutes,” says Mike Deines, global director of mar-keting for the genomics unit of Thermo Fisher. “We have built a community of more than 30 mem-bers, with the mission to collec-tively advance the state of the tech-nology and research.”

With each company running a similar program in different, though adjacent areas, Deines says, there is ample opportunity for the companies to learn from the strengths of each other’s pro-grams. Further, with the resources at hand with Thermo Fisher, there is the opportunity to strengthen the Open Access program by bringing group members to a single loca-tion, as opposed to the quarterly conference calls Open Bio current-ly conducts for the program.

In addition, Deines sees syn-ergies between the work Open Biosystems is doing to develop new products and ongoing work being conducted internally for the Thermo Fisher’s Colorado opera-tion, which Thermo acquired via

OpEN BIOContinued from pAge 16

its acquisition of RNAi and oligo specialist Dharmacon in 2004.

Deines, who came to Thermo Fisher through the Dhamracon acquisition, states, “The team here can very much relate to the size and stage that Open Biosystems is now and that we can help them adapt to the integration and focus on their technology.”

With its new parent company’s vast resources and also recently free of ongoing litigation with Sigma-Aldrich, which Moore admitted put a strain on the com-

pany, it appears Open Biosystems and its products are poised to make an ever-greater impact on the market.

Moore is quick to point out, however, that the decision to sell was not based on any financial

hardship brought about by the legal battle.

“We weathered that quite well, but we got to a point where we wanted to grow more rapidly,” Moore says. “As important as our open source philosophy is, this

wasn’t ever meant to be a ‘lifestyle’ business. Our aim was to bring our technology to as many people as we could and be profitable.”

The final purchase price for Open Biosystems, which report-ed revenue of $14 million in 2007, was not disclosed by either party. Though using a broad range of multiples for similar tools and reagents companies sold in the past couple of years, the final price likely fell in the $35 million $70 million range. ddn

editConneCt: e080809

marily monoclonal and polyclonal antibodies—which are used in medical and academic research, as well as drug discovery. The com-pany also provides recombinant proteins and custom antibody-production services

“Affinity BioReagents is an ideal complement to our existing capa-bilities in protein research,” says Marijn E. Dekkers, president and CEO of Thermo Fisher Scientific in a statement announcing the deal. “This acquisition enhances our extensive antibody portfolio, which will drive growth as we combine these reagents with our current proteomics offerings to create end-to-end solutions for widely used protein-research applications.”

Specifically, Budde says, the ABR products fit particularly well with the Piece line of products. “I’m responsible for the legacy Pierce products and combing them with ABR’s line was one of the main drivers for this deal,” he notes.

Pierce applications that may be strengthened through the addition of ABR to Thermo Fisher appli-cations include Western blotting, ELISA, immunohistochemistry, flow cytometry and mass spectros-copy. ddn


ABRContinued from pAge 16

ThE NUmBER ONE CONCERN for us was that a company embraces our open source biology model. Of all the groups we talked to about this, Thermo Fisher clearly showed us that is was more than just talk and they saw us as a strategic fit.”—Troy moore, co-founder, Open Biosystems

automation & instrumentation18 Drug Discovery News • August 2008 For more information, visit www.DrugDiscoveryNews.com

ARtELContinued from pAge 16

qIAgENContinued from pAge 16

new technology, like many other new tech-nologies before it, broad adoption can be slow. Lerch admits that right now, IonGate is still primarily selling to early-adopters, but he sees interest growing in transport proteins among researchers in the fields of cardiac, neurologic and metabolic disorders. And that is where Artel comes in.

“Artel has a strong presence in pharma-ceutical companies that can benefit from SURFE²R,” Lerch says. “In addition, they have the infrastructure and what is very important, the same attention to quality and service that we have at IonGate.”

According to Kirby Pilcher, president of Artel, the similarity of the cultures of the two companies was what really sealed the deal.

“When we saw how sincere, hardworking and productive they are, it felt a bit like look-ing in the mirror,” Pilcher says. “We saw it

is a good company, turning out something that is leading in its class. It was our view there could be a market opportunity and we could help.”

In IonGate, Pilcher saw the opportunity to do for researchers what Artel has been doing

in liquid handling: provide a new tool to the researchers that would help them optimize their discovery and development processes.

“When it comes right down to it, Artel is not a liquid handling company, even though that is what we sell,” Pilcher explains. “What we really are is more a quality pro-cess company, than we are a liquid handling company. We just happen to apply that focus to liquid handling.”

The attention to engineering a quality process extends to the company’s custom-ers and it will be the same approach Artel takes when introducing the SURFE²R tech-nology.

For Lerch, Artel’s focus on applying the technology using a consultative, problem-solving approach with customers rang true. He is quick to point out that IonGate did not need to jump into an agreement with a U.S.-based partner right away.

“We knew that we only will have one chance to get this right,” Lerch says. “We weren’t looking for just another dealer for

our products here and that’s not what Artel was interested in either. This is really much more of a partnership than a distribution agreement.

A clear illustration of this point lies in the fact, that upon announcing the work it is doing with Artel, IonGate moved its U.S. office from Manhattan to a space within the Artel offices in Maine. Further, Artel and IonGate are currently in the early stages of developing a similar reciprocal agreement for IonGate to provide sales and service support to Artel in Germany, Austria and Switzerland, a region where it is not ade-quately represented, according to Pilcher.

Under the terms of the agreement, Artel will use its existing infrastructure to pro-vide sales, marketing and service sup-port to IonGate. Artel workers have been receiving education and training on the SURFE²R technology and, in time will have a dedicated service leader for the IonGate products. ddn


SERVICE FIRST: IonGate turned to Artel as its U.S. partner based on a similar philosophy on quality and providing service to the customer.

of Corbett, a customer it picked up when it acquired molecular diagnostics assay com-pany artus in 2005.

“We have perhaps 30 assays that were developed for use on Corbett’s Rotor-Gene, similar to how we have developed assays for other companies,” says Shriek, “but some-times instead of an OEM or distribution agreement you need to own the technology. There is a real need for automation, especial-ly in PCR, and the CAS 1200 provides that.”

With the acquisition, Qiagen can now supply researchers with tools, assays and reagents for each of the three steps of molec-ular testing: sample preparation, assay setup, and now with the Rotor-Gene, detection.

While Qiagen was most intent on acquir-ing Corbett to be able to fulfill each of these three needs, it has also been pleasantly sur-prised by the penetration Corbett instru-

ments have achieved in markets where Qiagen may not have a strong presence.

“We knew that Corbett had a stong pres-ence in Asia,” says Shriek. “What was a surprise was how they were selling to geog-raphies that we didn’t know had strong potential, like Arabian countries and South America.”

The move to sell to Qiagen came as the Corbett family was looking to cash out of its successful 20-year-old company, which boast two separate facilities, each run by either John Corbett, Sr. or John Corbett, Jr. In some ways, selling to Qiagen represented a level of continuity for many Corbett customers.

“Many of our customers are Qiagen cus-tomers as well,” says Corbett, Jr. “In addition,

Qiagen’s technology leadership in molecular sample and assay technologies, its global reach and extensive marketing, combined with strong relationships with researchers and leading laboratories around the world, bring exciting opportunities for Corbett.’”

Both Corbetts will stay on with Qiagen for the foreseeable future as consultants, primar-ily responsible for shepherding a handful of in-process R&D initiatives currently under-way at the company. Other senior managers are expected to stay with the company. In addition, Qiagen also recently announced the appointment as general manager of Helga Lubenow, a Qiagen executive who has expe-rience with past integrations. ddn


We knew that Corbett had a stong presence in Asia. What was a surprise was how they were selling to geographies that we didn’t know had strong potential, like Arabian countries and South America.”—Ulrich Shriek, VP of corporate business development, Qiagen

Wellcome Trust’s Case Control Consortium second phase goes to AffymetrixSANtA CLARA, Calif.—Affymetrix Inc. recently announced that the Wellcome Trust has award-ed to Affymetrix the second phase of its Case Control Consortium (WTCCC) project, the world’s largest-ever study of the genetics behind com-mon diseases. The second phase will analyze the genetic information of 60,000 additional individuals, 30,000 of them with the Affymetrix Genome-Wide Human SNP Array 6.0, plus 6,000 common controls.

“The first phase of the WTCCC study has been one of the most successful scientific collabora-tions in disease genetics worldwide,” said Leena Peltonen, M.D., Ph.D., professor, head of human genetics and deputy chair of WTCCC2 at the Wellcome Trust Sanger Institute. “The second phase will substantially increase the genetic knowledge of common diseases and drug response.”



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Focusing on the ’omics

By JeFFrey Bouley

Five years ago, the Human genome Project came to an end, but most of the questions it raised have not been answered and the mountains of data it spawned

have barely been scratched. There are, after all, between 20,000 and 25,000 genes to deal with. and so, in the shadow of that proj-ect, major new genomics-related initiatives are coming forth to delve deeper, some of the chief among them being the Human Microbiome Project, the 1000 genomes Project and the Multiplex initiative—all of which enjoy significant participation or sponsorship by the National Human genome research institute (NHgri) of the National institutes of Health (NiH).

“The Human genome Project raised huge questions and has opened many untapped areas of study,” notes Dr. alan guttmacher, acting director of NHgri. “so part of what we, academia and private industry are doing is engaging in the natural intellectual next steps of trying to answer the questions that we can finally start answering—now that we have the entire genome in hand.”

The basic ongoing mission is twofold, guttmacher notes: get a better grasp of basic human biology and use greater knowledge of the genome to improve human health. Both are critical missions for drug discovery and development, even if there have been few huge breakthroughs in the short run.

“a couple of years ago, people would act like, ‘We have the genome today, shouldn’t we have a bunch of new drugs tomorrow? and that’s the problem with every major invention in human history—going back to the telegraph, locomotive or, more recent-ly, the internet,” guttmacher says. “People overestimate the short-term impact and underestimate the long-term impact.”

The Human genome Project started the

ball rolling for drug discovery and develop-ment in the new “genomic era,” guttmacher says. The international HapMap Project and the encyclopedia of DNa elements (eNCoDe) project, which completed their phase 1 stages in 2005 and 2007, respectively, have helped researchers zero in even more on potential drug targets.

“in various genome-wide association studies so far, for example, we have huge amounts of a data that we didn’t have before to help us understand biology bet-ter,” guttmacher adds. “The result is we are already seeing many more opportunities and ideas for new therapeutic approaches and new druggable targets.”

human microBiome ProJect

one of the most anticipated new initiatives is the Human Microbiome Project (HMP), which some people have already dubbed the “second Human genome Project.” Part of the NiH roadmap for Medical research, HMP is charged with the mission to com-prehensively characterize the human micro-biota and analyze its role in human health and disease.

in broad terms, HMP has four goals: Determine whether individuals share a core human microbiome; understand whether changes in the human microbiome can be correlated with changes in human health; develop new technological and bioinformat-ic tools to support these goals; and address the ethical, legal and social implications raised by human microbiome research.

“The human microbiome is largely unex-plored,” notes Dr. elias a. Zerhouni, direc-tor of the NiH, “but understanding it is essential to understanding how microor-ganisms interact with the human body to affect health and disease.” if the HMP is suc-cessful in its goals, he says, it could trans-form prevention, diagnosis and treatment of

human illness.“We now understand there are more

microbial cells than human cells in the human body. The Human Microbiome Project offers an opportunity to transform our understanding of the relationships between microbes and humans in health and disease,” says Dr. alan M. Krensky, the director of the office of Portfolio analysis and strategic initiatives, which oversees the NiH roadmap for Medical research.

The challenge will be making the HMP manageable, because as daunting as the Human genome Project was, the HMP will be bigger and tougher, says Dr. Claire Fraser-Liggett, director of the University of Maryland’s institute for genome sciences. With a multitude of organisms and interac-tions to explore genomically, rather than a single genome itself, simply establishing a defined endpoint for HMP will be a major undertaking. also, optimum sampling strat-egies will need to be identified early on and analysis will have to go hand-in-hand with sequencing, she notes.

NHgri recently announced it will fund up to $2 million this year for research on new technologies to obtain microbe samples for use in sequencing programs for HMP.

Just as technological advances helped the Human genome Project complete its goals two years early, so too are new genomic and other advances making the HMP possible, notes Dr. Margaret McFall-Ngai, a professor of medical microbiology and immunology at the University of Wisconsin-Madison, and this next-gen technology will help make the “big can of worms” the NiH is opening with HMP a bit more manageable.

and if the can of worm ends up being bait to draw out new potential therapeutic

avenues in the human microbiome, or per-haps even new drug targets, so much the better for the drug discovery and develop-ment industry.

1000 genomes ProJect

Led by an international research consor-tium, the 1000 genomes Project aims to cre-ate the most detailed and medically useful picture to date of human genetic variation and will do so by sequencing the genomes of at least 1,000 people from around the world. The project is receiving major support from the Wellcome Trust sanger institute in Hinxton, england, the Beijing genomics institute shenzhen in China and the NHgri, and data from the 1000 genomes Project will be made easily and quickly available to the global scientific community through free public databases.

The project was announced in January and started the ball rolling without corpo-rate partners. as of June, the project is a public-private effort with the addition of sequencing technology developers 454 Life sciences of Branford, Conn., a roche com-pany; applied Biosystems of Foster City, Calif; and illumina inc. of san Diego.

“What the consortium is trying to do with 1000 genomes is possible only because of the new wave of sequencing technologies,” notes Dr. Francisco de la vega, vice president for soLiD system applications and bioinfor-matics at applied Biosystems. “Traditional sequencing for the human genome took so long and cost hundreds of millions, so it wasn’t reasonable to consider sequencing more than a few genomes. But now we can, and by bringing on three different sequenc-ing developers and possibly more corpo-rate partners later on, the project can move

august 2008 Feature:

While genomics and proteomics may still be the big guns right now of the ‘omics world, here are a few other up-and-comers that could impact drug discovery and development in important ways soon:

Metabolomics—The study of the complete set of small-molecule metabolites (such as metabolic intermediates, hormones and other signaling molecules and secondary metabo-lites) found within a biological sample.

Glycomics—The comprehensive study of glycomes and their genetic, physiologic, patho-logic and other aspects, this ‘omics area poses far more complexity and challenges potentially

than genomics and proteomics, given that genes have four building blocks and proteins have 20, but saccharides have a multitude of them.

Lipidomics—The large-scale study of non-water-soluble metabolites, using technologies such as electrospray ionization, mass spec-trometry and liquid chromatography-mass spectrometry.

Transcriptomics—This area examines the set of all messenger RNA molecules, or tran-scripts, produced in one cell or a population of them. Unlike the genome, which is roughly fixed for a given cell line (excluding mutations), the transcriptome can vary with external environ-mental conditions. ddn

KnoW your ’omics

RISE OF NEXT-GEN GENOMICSThe Human Genome Project was just the start; NIH is pushing hard on the genomics envelope

NHGRI researchers, along with those in academia and corporate pharma, are pushing hard to understand genomics better, as well as proteomics, metabolomics and other related ‘omics fields.

20 Drug Discovery News • august 2008 For more information, visit www.DrugDiscoveryNews.com

For more information, visit www.DrugDiscoveryNews.com noVemBer 2005 • Drug Discovery News 21For more information, visit www.DrugDiscoveryNews.com august 2008 • Drug Discovery News 21feature

forward more quickly and we can all have easier and faster access to technological improvements that will allow everyone to make even better sequencing tools.”

“The additional sequencing capacity and expertise provided by the three companies in the pilot phase will enable us to explore the human genome with even greater depth and speed than we had orig-inally envisioned, and will help us to optimize the design of the full study to follow,” says Dr. richard Durbin of the Wellcome Trust, who is co-chair of the consortium.

The 1000 genomes Project builds upon the international HapMap Project, which produced a comprehensive catalog of human genetic variation organized into neighborhoods called haplotypes. But while the HapMap catalog only identifies genetic variants that are present at a frequency of 5 percent or greater, the catalog produced by the 1000 genomes Project will map many more details of the human genome and how it var-ies among individuals, identifying genetic variants that are present at far lower frequencies. as such, the 1000 genomes Project may help point out genetic variations that could impact genomic- and pro-teomic-based therapies in terms of factors like efficacy, availability and deliverability.

the multiPlex initiatiVe

Unlike the HMP and the 1000 genomes Project, the Multiplex initiative—a joint effort on NHgri

www.invitrogen.com

©2008 Invitrogen Corporation. All rights reserved. These products may be covered by one or more Limited Use Label Licenses (see Invitrogen catalog or www.invitrogen.com). By use of these products you accept the terms and conditions of all applicable Limited Use Label Licenses. For research use only. Not intended for any animal or human therapeutic or diagnostic use, unless otherwise stated. F-077073-r1 US 0508

Lipid Kinase Profiling

Don’t settle for just one class Assay systems for targeting all classes of PI3 lipid kinases

Lipid kinases are attracting increasing interest within oncology and in�ammation research as potential targets for drug dis-covery. In particular, the PI3K/AKT/mTOR pathway is frequently up-regulated in cancer. As progress continues in kinase drug dis-covery, it has become evident that inhibition of multiple kinases is a viable strategy. Such a strategy may also prove e�ective for compounds targeting the PI3K family, as simultaneous inhibi-tion of mTOR and p110α appears to be a promising approach to targeting cancer.1,2 Therefore, understanding the selectivity of compounds within the PI3K family is crucial to understanding their e�cacy and minimizing o�-target e�ects.

Despite a high level of interest, quantitative and robust �u-orescence methods suitable for high-throughput assays across the PI3K family have proven di�cult to develop. Several factors contribute to this di�culty; �rst, many lipid kinases have inher-netly low turnover, necessitating a highly sensitive assay format. Also, variations in substrate speci�city and product identity require either multiple, di�erent detection formats or a univer-sal assay. Further, approaches typically taken for protein kinase assays, including chemical modi�cation of substrates and detec-tion with phosphospeci�c antibodies, are not readily applicable to lipid substrates.

Adapta™ Universal Kinase AssayTo address the need for high-throughput tools to assay com-pounds across multiple members of lipid kinase families, Invit-rogen has developed the Adapta™ Universal Kinase Assay. The Adapta™ assay detects ADP formation using a highly robust time-resolved FRET readout based on a europium and Alexa Fluor® 647 donor–acceptor pair. Importantly, the Adapta™ assay yields high Z’-factor values even at low levels of ATP conver-sion. To facilitate reproducible, robust assays, Invitrogen has also developed ready-to-use, stable, optimized formulations of lipid substrates. These substrates include PIP2 and PI in the presence of the background lipid PS, to assay Class I, Class III, and PI4K enzymes, and PI in the absence of PS, to assay either Class II or Class III PI3Ks. Collectively, the sensitive Adapta™ assay, optimized substrates, and highly puri�ed kinases enable pro�ling of small-molecule inhibitors across the entire PI3 kinase family (Figure 1).

Visit www.invitrogen.com/adapta to learn more about the Adapta™ Universal Kinase Assay, collection of kinases and lipid and peptide substrates, and pro�ling services.

References1. Fan, Q. et al. A dual PI3 kinase/mTOR inhibitor reveals emergent efficacy in

glioma. (2006) Cancer Cell 9:341–349.

2. Knight, Z.A. et al. A pharmacological map of the PI3-K family defines a role for p110alpha in insulin signaling. (2006) Cell 125:733–747.

Figure 1—Application of the Adapta™ Universal Kinase Assay to the PI3K family. A. Titration of all classes of lipid kinases in the PI3K family using the Adapta™ assay. B. Selectivity pro�le of commonly used PI3K inhibitors determined using the Adapta™ assay for the lipid kinases and the LanthaScreen™ assay format for protein kinases (mTOR, DNA-PK).

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By Jeffrey BouleyThe National Institutes of Health will spend up to $19.2 million in the coming two fiscal years on two programs for the Genes, Environment and Health Initiative that aim to help move information from genome-wide association studies into the world of clinical medicine.

One program, called “Imple-mentation Planning Grants for Educational, Behavioral, or Social Studies for Translation of Genetic Factors in Common Diseases,” will support research on initiatives studying how healthcare providers and consumers interpret informa-tion from genetic studies, as well as the behavioral or psychosocial aspects of clinical application of genetic findings.

The other program, called “Translation of Common Disease Genetics into Clinical Applications,” will fund studies that focus on pre-vention, therapeutic interventions and development of diagnostic, predictive, clinical trial and epide-miologic tools based on findings from genetic studies of common diseases. ddn

NIH to fund genome- to-clinic studies

a n d N i H ’s Nat i o n a l C a n c e r institute—is geared almost exclu-sively toward testing, specifically the interest level of healthy, young adults in receiving genetic test-ing for eight common conditions. But because the study will also look at how people who take such tests interpret and use the results in their own healthcare decision-making, the study is important to at least one therapeutic arena.

“The Multiplex initiative will provide insights that will be key to advancing the concept of per-

sonalized medicine,” said Dr. eric green, NHgri scientific director, when the initiative was launched just over a year ago. “as genomic technologies are introduced for wider use, researchers and cli-nicians will need to know how genetic susceptibility tests will be received by patients.”

The initiative derives its name from the fact that participants will be offered free multiplex genetic testing—testing for multiple genet-ic conditions simultaneously.

although the Multiplex initia-

tive doesn’t have a direct impact on pharma research, knowing how people will respond to genetic testing is important given the use of genomic testing in some clini-cal trials, the increasing impact of incidental findings in clinical stud-ies (see article on page 22) and the continuing quest toward person-alized medicine and translational (or bench-to-beside) research. The important thing, NHgri’s guttmacher notes, is to have many genomics efforts so we can find out as much as possible about our

biology and treating our diseases.“We are the National institutes

of Health, after all, and in doing so, many big genomics projects or getting involved in them, we fig-ured, why not actually improve human health,” guttmacher jokes. “genomics is going to be key to drug discovery and development. The drugs we have today really only target about 500 of our more then 20,000 genes. That’s a lot of untapped druggable space there. We want to close the gap with new technologies and news ideas.” ddn

Genomics &Proteomics

b r i e f s

22 Drug Discovery News • august 2008 For more information, visit www.DrugDiscoveryNews.com

Wellcome Trust, Affymetrix expand genotyping study

LONDON—U.K-based non-profit the Wellcome Trust will use Affymetrix’s genotyping technolo-gies for the second phase of its Case Control Consortium project. Phase 1 of the project began in 2005, with Wellcome Trust research-ers studying thousands of genotyped human samples for genes associated with coronary heart disease, hypertension, type 1 diabetes and type 2 diabetes, bipolar disorder, Crohn’s disease, rheumatoid arthritis and tuberculosis.

For this second phase of the program, researchers will analyze genetic information from 30,000 individuals using Affymetrix’s Genome-Wide Human SNP Array 6.0, as well as 6,000 common controls. In this leg of the study, the 14 research groups involved in the project aim to analyze the genetic information of 60,000 individuals for genetic links to 14 diseases and drug responses. These include schizophrenia, ulcerative colitis, psychosis, bacteriosis, pre-eclampsia and statin response, and a genome-wide association study of learn-ing difficulties. Genotyping services are being conducted through a partnership with the Affymetrix Services Lab.

Lonza acquires amaxaBASEL, Switzerland—In July, pharmaceutical, healthcare and life science supplier Lonza com-pleted its acquisition of amaxa, a supplier to the cell discovery market, and began integrating amaxa and its approximately 160 employees into the existing structure of the company.

It is expected that amaxa will significantly strengthen the cell discovery business of Lonza by complementing and expanding the existing portfolio. Among amaxa’s major products are high-end nucleic acid transfection systems and consumables for academia and pharmaceu-tical and biotech businesses. The company’s unique transfection method enables efficient and reproducible transfer of nucleic acids such as DNA or RNA into cells that are considered difficult or even impossible to transfect.

RainDance creates French subsidiary

LEXINGTON, Mass.—RainDance Technologies Inc., a provider of droplet-based tools for life sciences research, reported in July that it had formed a wholly owned subsidiary in Strasbourg, France. Operations are set to begin in September 2008. The subsidiary is intend-ed to support RainDance’s partnerships with European firms in the fields of drug discovery, genomics and molecular biology. Privately held RainDance makes devices that conduct rapid experiments with droplets measured in one-trillionths of a liter. The firm, founded in 2004, says the technology will be initially used to support genomic sequencing.

U.W.’s new fly in the ointment

U of Minn. spearheads guidance on incidental findings

PROTEIN POWERAlthea Technologies and Protein’eXpert accord connects early- and late-stage needs for client projectsBy Jeffrey Bouley

SAN DIEGO—Althea Technologies Inc., a provider of technology and services for pharmaceutical development and manufacturing, has signed a letter of intent to establish a complementary commercialization partnership with Grenoble, France-based Protein’eXpert, a contract research organization devoted to recombinant protein engi-neering and production for biomedical research applications focusing on optimization of valuable target or therapeutic proteins.

The transatlantic match-up, which was sparked by the introduction of the two com-panies through the LyonbioPôle and Invest in France Agency initiatives in the United States, brings together a set of offerings that should enable both companies to reach larger markets, broaden services for new and challenging prod-ucts and better match early- and late-stage client requirements for protein projects.

“I think on a macro level, the process of devel-oping drugs has focused on biotech drugs and protein products, and while Althea has a sig-nificant process development capability, we’re focused more upstream and the Protein’eXpert folks have a tremendous reputation and skill set that is very valuable in early stage development,”

says Alan Moore, executive vice president and CBO of Althea Technologies. “You don’t often see alliances between two companies like ours with such distinct audiences. But with increasing mar-ket pressures, it’s important to consider clinical manufacturing goals earlier in the development

Duke researchers may be on to a way to activate herpes long enough to kill itBy Jeffrey Bouley

D U R H A M , N . C . — D u k e University Medical Center scientists report that they have discovered how the herpes simplex virus 1 that causes cold sores remains dormant and hidden, and that they may also have a way to “wake it up and kill it,” as a recent Duke news release about the research puts it.

“We have provided a molecular understanding of how HSV1 hides and then switches back and forth between the latent and active phases,” says Bryan Cullen, Duke profes-sor of molecular genetics and microbiology.

Most of the t ime, he notes, HSV1 lives quietly for years in the trigeminal nerve of the face until trig-gered to reawaken by exces-sive sunlight, fever or other stresses—and thus it largely remains out of reach of any effective therapies. During the dormant period, HSV1 does not replicate itself and only produces one molecu-lar product, called latency associated transcript RNA (LAT RNA).

Wake up and die

Research uncovers new ‘pressure points’ against fluBy Jeffrey Bouley

MADISON, Wis.—As document-ed in the July 9 issue of Nature, researchers at the University of Wisconsin–Madison infected fly model Drosophila melano-gaster with influenza and iden-

tified, as the university notes in its news release about the research, “scores of host genes the pathogen requires for suc-cessful infection, revealing a raft of potential new pressure points to thwart the virus.”

Led by Yoshihiro Kawaoka and Paul Ahlquist, the U.W.-Madison team tested the ability of a modified flu virus to infect

cells whose genes were system-atically disabled to see which were co-opted by the virus. The importance of the research lies in the fact that this may demon-strate a “rapid-fire” technique for identifying host factors, such as proteins and carbohydrates, that a virus commandeers to successfully infect a cell. By

By Jeffrey Bouley

MINNEAPOLIS—When one thinks of byprod-ucts of pharmaceutical research, biomedi-cal waste might be the first thing that comes to mind for most, but an increasing area of concern is the leftover incidental health find-ings, says Susan Wolf, J.D., who chairs the University of Minnesota’s Consortium on Law and Values in Health, Environment and the Life Sciences. In its summer 2008 issue, the Journal of Law, Medicine & Ethics published a consensus paper that she and a multidisci-

plinary team of national experts developed to offer the first major guidelines on manag-ing incidental findings in human research.

An incidental finding is an unexpected discovery concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of conducting research, but is beyond the aims of the study. Because inci-dental findings can potentially save lives but also cause alarm, the decision on whether

althea continueD on page 24

flu continueD on page 25

duke continueD on page 24

findings continueD on page 25

By partnering with Protein’eXpert, Althea Technologies gains a foothold in Europe and sets eyes on possible Asian expansion.

“Researchers have traditionally drawn a bright line between their research activity and the clinical care of patients; incidental findings challenge that line,” says Susan Wolf, chair of the Consortium on Law and Values in Health, Environment and the Life Sciences.

Genomics & ProteomicsFor more information, visit www.DrugDiscoveryNews.com august 2008 • Drug Discovery News 23

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simply drew a bar related to what they were willing to continue in terms of outside funding, and Nastech fell on the wrong side of that bar.”

As French describes it, “the market crushed Nastech over that. It’s hard to go back and try to con-vince people that it’s the partner, not the drug. Frankly, the market just doesn’t care a lot of the time.”

What followed was a contrac-tion of the staff from 250 people to a total of 80 today, and discussions about what direction to take. Since 2003, Nastech has in-licensed RNAi technologies from compa-nies such as Alnylam. Based on this activity, company officials decided to bring RNAi to the fore-front and completely re-brand the company. The company’s leaders believe they have been building one of the broadest and deepest patent estates in the RNAi field, with more than 260 filed patents addressing 144 gene sequences including numerous disease-vali-dated targets.

“Nastech found itself with a dwindling market cap and three clinical programs that, as you can imagine, would require a lot of money to keep moving forward,” French notes. “So with limited capital to work with, the compa-ny decided to go with getting the most bang for its buck by taking advantage of growing interest in RNAi platforms and leverage its intellectual property in the RNAi space—work that had been going on slowly and quietly in the shad-ow of the three clinical programs for nasal delivery.”

Reborn as mdRNA, the com-pany now focuses in part on Dicer substrates—through an intellec-tual property license deal with City of Hope. Dicer substrates are oligonucleotides which are slight-ly longer than standard “RISC” substrates and are processed by the Dicer enzyme into the siRNA strands. These strands then acti-vate the RNAi pathway.

Plans call for mdRNA to tap the unique characteristics of Dicer substrates to develop novel deliv-ery approaches for safe and effec-tive systemic delivery of RNAi-based therapeutics.

The other major focus involves RNAi drug candidates based on the use of Meroduplex, or mdRNA, a next-generation oligonucleotide technology being developed by the company as a platform approach for the development of potentially safer and more efficacious RNAi-based therapeutics.

Currently, mdRNA is pursu-ing preclinical RNAi programs in influenza and rheumatoid arthritis, from which it will identify appropriate target candi-dates for partnering and clinical development.

As for the nasal delivery tech-

nology, mdRNA is seeking to monetize that legacy drug delivery business through licensing, part-nering or acquisition of its Phase II intranasal programs—with an eye toward using the revenue to fur-ther bolster its RNAi mission.

French replaced Dr. Stephen C. Quay as CEO when Nastech re-branded itself, but Quay remains on board as chief scientific officer, chairman of the company’s scien-tific advisory board and chairman of the board of directors.

“I am looking forward to focus-

ing my attention on the further development of our core deliv-ery technologies and the rapid advancement of our preclinical pipeline of novel mdRNAi and siRNA drug candidates toward human clinical development,” Quay says. “This is an exciting time for me and our world-class scientific team as we continue to capitalize on the breakthroughs we have made in developing safe and effective RNAi-based thera-peutics.” ddn


Cenix signs research agreement with Regulus for miRNA-targeted drug discoveryDrESDEN, Germany—Cenix BioScience GmbH, a specialist in RNA interfer-ence (RNAi)-based research services, in late July signed a research agree-ment with Regulus Therapeutics LLC to advance the latter’s efforts in the discovery of novel therapeutic miRNA modulators.Cenix will apply its well-established expertise in combining high-throughput applications of small RNA-based gene silencing with high content phenotypic analyses in cultured human cells. The company will thereby screen libraries of synthetic miRNA modulators designed and produced by Regulus, using multi-parametric assays to identify novel lead molecules offering highest therapeutic potential in the area of immunology and inflammation. ddn

Genomics & Proteomics24 Drug Discovery News • august 2008 For more information, visit www.DrugDiscoveryNews.com

process for a drug.”Clients will gain access to

Protein’eXpert’s advanced protein engineering, process development and optimization expertise, with the full realm of cGMP manufac-turing resources for production and fill/finish services from phase I clinical to commercial manufac-turing provided by Althea.

“The partnership with Althea Technologies is a great oppor-

ALThEAcontinueD fRom page 22

tunity for us,” says Dr. Tristan Rousselle, CEO of Protein’eXpert. “Their very strong position on the U.S. market and their outstanding production facilities shall perfectly complement our expertise and set of services based on recombinant protein engineering, development and small-scale GMP production.”

In addition to providing Althea clients with valuable early-stage process development capabilities, the deal also should strengthen Althea’s presence in Europe, notes Dr. Magda Marquet, president and

Co-CEO of Althea Technologies. “We have been working with

Althea Technologies for sev-eral months to develop the opti-mal solution for its business in France,” said Alexandre Thermet, vice president of Invest in France Agency–North America, in a news release announcing the deal. “The level of expertise and innovation offered by the Lyonbiopôle clus-ter, in addition to recent incen-tives implemented by the French government, led us to identify Protein’eXpert as an ideal partner

for Althea Technologies. We will continue to work with Althea to ensure that they fully benefit from the range of advantages France is currently offering companies in their field.”

Moore says Althea has been interested in entering the European market for the past four years and really started exploring the pos-sibility in the past year. With the pharma universe having “three primary centers of innovative drug development” and Althea now having inroads to two of them—the

United States and Europe—Moore says his company is keen to explore further geographic expansion and partnering, with the next such deal quite likely to be in Asia. ddn


Cullen says that it has “always been a mystery” what LAT RNA does. “Usually viral RNAs exist to make proteins that are of use to the virus,” he adds, “but this LAT RNA is extremely unstable and does not make any proteins.”

In mice, the Duke team showed that the LAT RNA is processed into smaller strands of microRNAs that block production of the pro-teins that make the virus initiate active replication. As long as the supply of microRNAs is sufficient, the virus stays dormant.

After a larger stress, however, the virus starts making more mes-senger RNA than the supply of microRNAs can block, and protein manufacturing begins again. This tips the balance, and the virus ulti-mately makes proteins that begin active viral replication. These find-ings were recently published in the journal Nature.

Other herpes viruses also make significant use of microRNAs, but in a different way in many cases, so Cullen doesn’t necessarily think his team’s findings have a wider application for all herpes, particu-larly not for Epstein-Barr virus, cytomegalovirus, or the herpes viruses associated with roseola or Kaposi’s sarcoma.

But there are very likely insights that can be applied in develop-ing treatments for herpes simplex virus 2, which affects the genitals, and possibly for herpes zoster as well, which causes chickenpox and can resurface in adulthood to cause shingles.

The approach to curing HSV1, and possibly HSV2 and herpes zos-ter, would be a combination thera-py, Cullen says, adding, “Inactive virus is completely untouchable by any treatment we have. Unless you activate the virus, you can’t kill it.”

So, he and his team are testing a new drug designed to very precise-ly bind to the microRNAs that keep the virus dormant. If it works, the virus would become activated and start replicating. Once the virus is active, a patient would then take acyclovir, a drug that effectively kills replicating HSV1.

“In principle, you could acti-vate and then kill all of the virus in a patient,” Cullen says. “This would completely cure a person, and you would never get another cold sore.”

He and the team are now work-ing with drug development com-panies in animal trials to begin to answer questions about how to deliver such a drug most effec-tively. ddn


DukEcontinueD fRom page 22

Genomics & ProteomicsFor more information, visit www.DrugDiscoveryNews.com august 2008 • Drug Discovery News 25

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or not to disclose them to research participants has been a longstand-ing dilemma.

To some degree, that dilemma had been something that could be pushed to the side, but with increasingly powerful technolo-gies, particularly in the area of genomics, more and more “extra” data is being generated, including incidental findings, Wolf notes.

“Incidental findings are an unavoidable byproduct of phar-maceutical and medical research—and in drug discovery and devel-opment, they can crop up just as easily in preclinical work or in reviewing archived data as they can in clinical studies,” Wolf says. “As methods and technologies become more advanced, we simply cannot ignore the ethical implica-tions of incidental findings, nor the legal implications.”

Researchers often stumble upon unexpected findings but have no idea whether to share this infor-mation with research participants, Wolf notes, and they have no way of knowing whether the informa-tion will prove highly significant or simply be a false alarm.

The University of Minnesota-led effort, a two-year project sup-ported by the National Human Genome Research Institute at the NIH, is the first to truly look at the issue from the perspective of the research subject, Wolf believes.

The project members concluded that it is essential to address the possibility of incidental findings in the consent process. Researchers should set up a process for recog-nizing them and verifying whether there is indeed a suspicious find-ing of concern, and they should take steps to validate an incidental finding and confirm its health or reproductive importance before offering the finding to a research participant. Additionally, a re-searcher who lacks the expertise to make this assessment may need to consult with a clinical colleague.

“This is going to take a lot of time, effort and money, but proper-ly handling incidental findings and sharing those plans with research participants has to become a rou-tine part of planning and budget-ing,” she says. ddn


exposing the virus’s dependen-cies, the researchers are confident they have uncovered a target-rich environment for influenza drug developers.

Although the work was done in cells of a fruit fly, most of the genes have mammalian analogs and ini-tial tests in human cells of three of the 100 genes identified confirmed all three are necessary for the virus to successfully make copies of itself

fLucontinueD fRom page 22

to promote infection. “The genes we identified in

mammalian cells are very specific for influenza,” says Kawaoka, a flu expert and a professor of patho-biological sciences at the U.W.-Madison’s School of Veterinary Medicine. “Now we know influen-za viruses are using specific host proteins so those become targets for drug development.”

“Viruses are typically very ‘gene-poor’ and even though some of them have hundreds of genes, something on the order of five or

10 genes is more common, with flu at the larger end of that range,” explains Ahlquist, a Howard Hughes Medical Institute investi-gator at the university. “Compared to that, a host cell has tens of thou-sands of genes, and one of the great mysteries of viruses is how they do everything they need to do with so few genes. Obviously, they leverage the considerably greater resources of the host cell, but this research gives us more insight into how they do it exactly so that we know what critical host functions

the virus is using.”The problem with antiviral med-

ications used right now, whether for the flu or for other infections like HIV, is the drugs attack func-tions in the viruses’ own genes. But because viruses mutate so fast, they quickly become resistant to those drugs.

“What previous research has show with down-regulating cell functions, is that we can theoreti-cally down-regulate a cell to a level where it is still healthy and happy, but create a situation in which the

virus is in trouble,” Ahlquist says. “Viruses are all about pushing cells to extremes to create as many prog-eny as possible. But now we may be on the path to creating drugs that can deny them that ability and create medications that are much harder for a virus to overcome.”

Both Ahlquist and Kawaoka say the new system has potential appli-cation beyond studies of influenza and could help speed the develop-ment of antiviral drugs for many diseases, including AIDS. ddn


fINDINGScontinueD fRom page 22

b r i e f s

research & development

26 Drug Discovery News • AUGUST 2008 For more information, visit www.DrugDiscoveryNews.com

Lilly acquires oncology biotech SGX Therapeutics for $64 MillionBy Amy SwindermAn

INDIANAPOLIS—What began as a research development partnership between Eli Lilly & Co. and San Diego-based oncology biotech company SGX Pharmaceuticals Inc. has ended in a buyout. On July 8, Lilly announced the compa-

nies signed a definitive merger agreement providing for the acquisition of SGX in an all-cash, $3 per-share cash trans-action totaling approximately $64 million.

The acquisition expands Lilly’s footprint in the San Diego area and gives it access to Fragments of Active Structures (FAST), SGX’s fragment-based, protein structure guided drug discovery technology, and a portfolio of preclinical oncol-ogy compounds focused on a

number of high-value kinase targets. The transaction is expected to close in the second half of 2008.

Lilly declined to comment on the acquisition. Dr. Steven M. Paul, executive vice presi-dent of Lil ly Science and Technology, said in a statement that the acquisition builds on a collaboration that began in 2003 in which Lilly used SGX’s proprietary x-ray crystallogra-phy technology to determine

Metabolon in diabetes research pact with UT Health

Science CenterRESEARCH TRIANGLE PARK, N.C.—Diagnostic and services company Metabolon Inc. has partnered with the University of Texas Health Science Center at San Antonio to discover and validate biochemical biomarkers reflective of insulin resistance and beta cell dysfunction, according to an agreement announced by the parties in July. Using its patented biochemi-cal profiling platform, Metabolon will analyze samples from various studies conducted by the research team of Dr. Ralph A. DeFronzo, a lead-er in diabetes research, specifically addressing the major pathophysiological pathways that lead to the development of type 2 diabetes, including insulin resistance and pancreatic dysfunction. The partnership is expected to help drive development of Metabolon’s pre-diabetes diagnostic products as well as provide valuable data for insulin resistance and diabetes-relat-ed research. Financial terms of the agreement were not made available.

Cellzome extends Alzheimer’s disease collaboration with OMJP and J&J

BOSTON—Cellzome Inc. has extended its Alzheimer’s disease research collaboration with Ortho-McNeil-Janssen Pharmaceuticals Inc. (OMJP) and its affiliate, Johnson & Johnson Pharmaceutical Research & Development LLLC for two more years. Since 2005, the compa-nies have worked to select and progress novel Gamma Secretase Modulators and novel tar-gets from the Amyloid Precursor Protein (APP) pathway. Under the new agreement, which has been extended to 2010, Cellzome will map the Tau pathway. OMJP has exclusive rights to the intellectual property on compounds chosen for clinical development and commercializa-tion. In exchange, Cellzome receives a technol-ogy access fee and research support as well as milestones and royalties on sales. Further financial details were not disclosed.

Genelabs, NHRI collaborate on hepatitis C drug candidates

REDWOOD CITY, Calif.—Genelabs Technologies Inc. has entered into a collaborative research agreement with the National Health Research Institutes (NHRI) to discover and develop com-pounds that target the hepatitis C virus (HCV). HCV drug candidates will be developed using Genelabs’ lead compounds on an existing target the chemistry and drug discovery expertise of the NHRI, a non-profit organization established by the government of the Republic of China and Genovate Biotechnology Co. Ltd., a biopharma-ceutical company in Taiwan. Financial terms of the agreement were not disclosed.

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ViroPharma acquires Lev Pharmaceuticals and inflammatory disease program

By Amy SwindermAn

EXTON, Pa.—Focused on broad-ening its portfolio of therapies for life-threatening conditions in selected specialty markets, ViroPharma Inc., a developer of products for serious diseases treated by physicians and in hos-pital settings, has acquired Lev Pharmaceuticals Inc., a biop-harmaceutical company focused on developing therapeutic prod-

ucts for inflammatory diseases. The transaction could be worth a potential net aggregate value of $617.5 million.

The transaction involves an upfront payment of $442.9 mil-lion, or $2.75 per Lev share, comprised of $2.25 per share in cash and 50 cents per share in ViroPharma common stock. Contingent consideration of up to $1 per share may be paid on achievement of certain regulato-ry and commercial milestones. In addition, ViroPharma pur-chased $20 million of Lev com-mon stock. The transaction is expected to be completed by the

end of this year.The acquisition is expected

to boost ViroPharma’s pipeline with the addition of Cinryze,

Lev’s lead product candidate for both the acute and prophy-lactic treatment of hereditary

Genzyme and PTC Therapeutics to develop small molecule for genetic diseasesBy Amy SwindermAn

CAMBRIDGE, Mass.—Biotechnology company Genzyme Corp. and PTC Therapeutics, a devel-oper of small molecule drugs that target post-tran-scriptional control processes, have joined forces to develop and commercialize PTC124, PTC’s novel oral therapy in late-stage development for the treatment of genetic disorders due to nonsense mutations.

According to the agreement, announced July 17, PTC will commercialize PTC124 in the United States and Canada, while Genzyme will com-mercialize the treatment in all other countries. Genzyme will make a $100 million upfront pay-ment to PTC Therapeutics, which will conduct

and bear the expense for the Phase IIb trial of PTC124 in Duchenne muscular dystrophy (DMD), the Phase IIb trial in cystic fibrosis (CF) and two proof-of-concept studies in other indications to be determined. Once the four studies are completed,

GO FiSHZnomics, OHSU use zebrafish screening to identify inflammatory disease therapeuticsBy Amy SwindermAn

P ORTLAND, Ore.—Hoping to restore a focus on basic biol-ogy in the drug discovery pro-cess, Zebrafish-screening firm Znomics Inc. has launched a collaborative research program with Oregon Health & Science University (OHSU) to develop pre-clinical compounds to treat inflammatory diseases.

Znomics will work with Dr. Thomas Scanlan, director of O H SU ’s C h e m i c a l B i o l o g y Program, to design and devel-op pre-clinical compounds to treat diseases such as rheu-matoid arthritis, asthma and inflammatory bowel syndrome. Scanlan has conducted leading work in small molecule discov-ery in “dissociating glucocor-ticoid” compounds that retain the desired anti-inflammatory action, but without having the serious side effects of steroids. Znomics will fund the program and has the option to exclusively license the rights to the discover-ies. Financial terms of the agree-ment were not released.

Znomics and OHSU have been partners for many years. Znomics leases space from the

nOnSenSe cOnTinUed On PaGe 29

CinryZe cOnTinUed On PaGe 27

“Lev is younger and less mature than the status of this drug. ViroPharma has the regulatory experience to increase the probability of getting regulatory approval as fast as possible, then taking advantage of that approval as soon as it arrives and commercializing it.”—Vincent J. Milano, ViroPharma President and CEO

FiSH cOnTinUed On PaGe 29 FAST cOnTinUed On PaGe 27

Dr. Stuart W. Peltz, PTC’s president and CEO, says developing PTC124 with Genzyme “is exciting because it brings to fruition the concept of personalized medicine.”

research & developmentFor more information, visit www.DrugDiscoveryNews.com AUGUST 2008 • Drug Discovery News 27

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angioedema (HAE), also known as C1 inhibitor deficiency. Cinryze is currently under regulatory review for approval by the FDA.

ViroPharma President and CEO Vincent J. Milano says the Lev acquisition is a strategic fit for ViroPharma, which he character-izes as “truly entrepreneurial.”

“If you compare and contrast us to some of the big specialty phar-maceutical companies, we like

to be in places where there is a much smaller number of patients,” Milano says. “At this stage of our company’s growth, we are in the unique position of being a profit-able biotech company, but we’re driven not by earnings growth as much as we are by building sus-tainable growth. The founders of Lev are more entrepreneurial, too, so Lev brings to ViroPharma its expertise as well as operational synergies.”

Cinryze targets a market that is addressable with modest addi-

tional infrastructure and further serves patients suffering from a disease with few treatment options, Milano adds.

“Lev has done a phenomenal job in advancing Cinryze to the stage of development it is currently in,” Milano says. “Today, the only ther-apy available for HAE is anabolic steroids. We all know from the industry itself or reading the news-paper that steroids can cause tons of major side effects. Cinryze will be first and likely best treatment to help manage this disease. Lev is

younger and less mature than the status of this drug. ViroPharma has the regulatory experience to increase the probability of getting regulatory approval as fast as pos-sible, then taking advantage of that approval as soon as it arrives and commercializing it.”

Lev, which was founded in 2003 and is located in New York, did not respond to a request for comment, but Judson Cooper, Lev’s chair-man of the board, said in a state-ment that the acquisition provides shareholders with attractive finan-

cial terms, through the upfront payment and the opportunity to continue to share in the success of Cinryze through the ownership of ViroPharma shares and the con-tingent value rights.

“L everaging the combined resources of both companies not only strengthens our C1 inhibitor development platform, but also underscores our commitment to serving patients with critical unmet medical needs,” Cooper said in the statement. ddn

ediTCOnneCT: e080817

CINRYZEcOnTinUed frOM PaGe 26

three-dimensional structures of key Lilly drug targets.

In December 2003, the compa-nies expanded their agreement to provide Lilly with long-term access to SGX’s beamline facility at the Advanced Photon Source in Argonne, Illinois, to support Lilly drug discovery programs. Under the terms of the agreement, SGX generates crystal structure data on Lilly drug targets and compounds.

“After a successful collaboration over the past several years, we are excited to bring the scientific and technological expertise of SGX into Lilly’s research organization, while at the same time expanding our presence in the San Diego area,” Paul said in a statement announc-ing the acquisition. “We will lever-age the combined resources of both companies to strengthen our structural biology capabilities and seek out innovative therapies for patients.”

Dr. Stephen Burley, CSO and senior VP of SGX, says the acqui-sition will accelerate the potential of SGX’s platform and pipeline to be realized, while simultaneous-ly providing shareholders with attractive financial terms.

FAST is based on SGX’s propri-etary fragment library of approxi-mately 1,000 structurally diverse, low molecular weight compounds. SGX’s drug development pro-grams target the MET receptor tyrosine kinase, an enzyme impli-cated in a broad array of can-cers, and the BCR-ABL tyrosine kinase enzyme for the treatment of Chronic Myelogenous Leukemia (CML). Its drug discovery activi-ties are focused on a portfolio of other protein and enzyme targets including JAK2, RON, ALK, RAS and IKKe that have been implicat-ed in human cancers.

“This deal presents the oppor-tunity to apply the SGX platform to additional Llly targets,” Burley says. “We share a dedication to scientific excellence, core values and a strong belief in the power of structure. We have developed a very synergistic partnership between drug discovery and struc-tural biology which we hope will eventually permeate all of Lilly drug discovery.” ddn


FASTcOnTinUed frOM PaGe 26

28 Drug Discovery News • AUGUST 2008 For more information, visit www.DrugDiscoveryNews.comresearch & development

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Yanai says the deal will put the Israeli company ahead of its stat-ed plan to double its overall sales by 2012, a goal which was calcu-lated based on organic growth and smaller acquisitions, such as the Bentley and CoGenesys deals. With Barr, it adds $2.5 bil-lion in annual sales and combined sales for the two companies were $11.9 billion in 2007, a number that is expected increase by 15 percent

this year.In all, Barr is expected to add

important economies of scale for Teva—an important factor in the lower margin generics business—and provide as much as $300 mil-lion in savings to the company through consolidation.

The deal also makes Barr the latest global generic drug maker to succumb to the consolidation frenzy that is sweeping the gener-ic sector.

Other recent billion-dollar-plus generic deals include Daiichi

S a n kyo’s $ 4 .6 b i l l i o n ag r e e -m e nt t o ac qu i r e c o nt r o l l i n g interest in Indian generic drug maker Ranbaxy and Fresenius’ United States market entry via its $3.7 billion purchase of APP Pharmaceuticals. Also ongoing is the bidding for Czech generic company Zentiva by sanofi-aventis whose $1.9 billion bid was rebuffed by the company.

The acquisition of Barr is of a slightly different flavor than others it has completed in the past.

“Teva’s acquisitions focused

mainly on acquiring assets that provided it with delivery technolo-gies and/or geographic exposure, whereas a potential acquisition of Barr Pharmaceuticals would pro-vide Teva with access to the oral contraceptive market, enhance Teva’s presence in Central and Eastern Europe, and be an oppor-tunity to eliminate duplicate infra-structure in the US,” said Ricky Goldwasser, an analyst at UBS Investment Research in a news report in The Jerusalem Post.

Further, according to Barr

C h a i r m a n a n d C E O B r u c e Downey, the combination of the two companies makes sense due to the fact there is very little overlap in the areas where each markets their generic products.

“If you look at our generics business the products are very complementary with Teva’s and have very little overlap. If you look at the markets where we are strong ex-U.S. to help propel them to a higher level in eastern and central Europe [and] it will allow us to put separation between Teva and companies here in the U.S.,” says Downey.

Yanai concurs, adding “Even though we are playing on the same ground for a long time we have been playing different ways—and that is why we are so excited about this deal.” ddn


TEVAcOnTinUed frOM PaGe 1

LOUISVILLE, Ky.—Advanced Cancer Therapeutics (ACT), a private anti-cancer drug developer, has signed two collaborative agreements that will advance its novel vaccine program for human papil-lomavirus (HPV), a leading cause of cervical, anal and vaginal cancer. ACT’s vac-cine, to be produced in tobac-co plants, targets the minor capsid, or L2, protein, an inte-gral part of the papillomavi-rus capsid.

Under the f irst agree -ment, announced in July, the University of Louisville’s James Graham Brown Cancer Center granted ACT exclusive worldwide development and commercialization rights to monovalent vaccines derived from L2. Under the second agreement, ACT has exclusive worldwide development and commercialization rights to Kentucky BioProcessing LLC (KBP)’s GENEWARE plant based gene expression system for development of an HPV vaccine. The GENEWARE system uses a specifically altered tobacco mosaic virus as a vehicle to carry a target protein. Thenatural growth of the plant produces large quan-tities of the protein. Financial terms of the agreements were not released.

“ These agreements are central to the timely and effi-cient development of a novel vaccine and we look forward to continuing our collabora-tions as we work towards this common goal,” says ACT president and CEO Randall B. Riggs. ddn

ACT licenses technologies to develop HPV vaccine

research & developmentFor more information, visit www.DrugDiscoveryNews.com AUGUST 2008 • Drug Discovery News 29

the companies will share research, development and commercializa-tion costs equally.

PTC is also eligible to receive up to $165 million in development and approval milestones, the major-ity of which are to be paid upon approvals in Genzyme territories; and up to $172 million in sales milestones, contingent upon the achievement of specific sales lev-els, for a total potential of $337 mil-

lion. The sales milestone payments begin when annual net revenue reaches $300 million, and increase in increments up to $2.4 billion.

PTC124, initiated in 2004, has already been granted orphan drug status for the treatment of DMD and CF due to nonsense mutations by the FDA and the European Commission.

Genzyme Chairman and CEO Henri A. Termeer says the collabo-ration is a strategic fit for Genzyme, which has extensive experience with cystic fibrosis and has devel-

oped Myozyme, a treatment for the genetic disorder Pompe disease, which is often treated by physi-cians who also treat DMD.

“Over the past two decades, G e n z y m e h a s s u c c e s s f u l l y developed four therapies for patients with severe genetic dis-eases. PTC124 is a powerful new approach that holds great potential to help CF and DMD patients, and many others with a variety of dev-astating diseases,” Termeer said in a statement released by Genzyme.

Dr. Stuart W. Peltz, PTC’s presi-

dent and CEO, says the collabora-tion supports PTC’s goal of estab-lishing a fully integrated biophar-maceutical company by retaining commercial rights in the United States and Canada, while engaging an experienced partner to address additional markets. The collabo-ration will also fill a significant unmet medical need, he adds.

“This partnership will fulfill our dream of not just developing drugs, but also commercializing them,” Peltz says. “P TC124 is exciting because it brings to frui-

tion the concept of personalized medicine. PTC124 is a investiga-tional drug that helps treat the underlying disease due to a type of mutation. A subset of patients in hundreds, if not thousands, of different genetic diseases may be helped by this drug. I think this will have a significant impact on how we think about making drugs, where you not only need to know about the disease, but also the genotype of the disease, down to the nucleotide level.” ddn


NONSENSEcOnTinUed frOM PaGe 26

university, and the new research agreement evolved out of work that was done in the OHSU lab of Dr. Roger Cone, a Znomics co-founder and zebrafish technology pioneer.

“We have allowed our academics to take the time to grow the com-pany,” says Cone, now a senior sci-entist at OHSU’s Vollum Institute. “We’re now in the growth stage, where the academics are stepping back to an advisory role and hir-ing professionals to design new compounds.”

Znomics is excited about the opportunity to work with Scanlan and identify drugs for debilitating inflammation-related diseases, “which is a large unmet medical need,” says CSO Bruce Beutel.

“One of the special things about Znomics is its relationship with the academic community,” Beutel says. “I view our relationship with OHSU as another good example of this kind of academic-industry collaboration.”

A vertebrate with genes homol-ogous to approximately 80 to 90 percent of the genes found in humans, zebrafish can be rapidly and cheaply generated and are easy to be studied because of their transparency. Znomics’ ZeneMark Library, a comprehensive and searchable collection of mutant zebrafish lines, contains muta-tions in more than 11,000 different zebrafish genes, many of which are similar to human genes.

Beutel, who recently joined Znomics after more than 12 years of pharma experience at Abbott Laboratories, says the zebrafish whole animal approach can have a significant impact not just on this partnership, but also on the drug discovery process in general.

“The zebrafish technology has been undervalued by the phar-maceutical industry because it is still really new, with most of the new science evolving in the aca-demic community,” he says. “The zebrafish are unique in that you can screen large numbers of compounds, but you can do it in a whole animal where all possi-ble therapeutic targets are being screened at once for their potential across many disease areas.” ddn


FISHcOnTinUed frOM PaGe 26

mOre [email protected]

30 Drug Discovery News • August 2008 For more information, visit www.DrugDiscoveryNews.comnew products

Rapid, Multiplex Detection of Validated tumor MarkersEMD ChemicalsTo accelerate the progress of cancer drug discovery and preclinical stud-ies, EMD (the North American affiliate of Merck KGaA, Darmstadt, Germany) in partnership with Rules Based Medicine (RBM) has released the

first of a series of new WideScreen Biomarker Assay Kits. These multiplex immunoassays, for the Luminex xMAP Technology platform, utilize technolo-gies that have been validated by RBM in its HumanMAP and RodentMAP service platform. WideScreen Human Cancer Panel 1 can be used to detect six critical tumor biomarkers in human serum, plasma, or tissue culture supernatant samples. These biomark-ers were carefully chosen to serve as sensitive, and specific indicators of a variety of tumors. Biomarkers detect-ed in the WideScreen Human Cancer Panel 1 are: alpha-fetoprotein (AFP), CA 125, CA 15-3, CA 19-9, carcinoem-bryonic antigen (CEA), and prolactin. The kit includes all reagents, controls, and buffers needed to perform 96 tests. For more information, see www.novagen.com/widescreen.

EMD Chemicals800-854-3417www.emdchemicals.com

Direct Benchtop tube Printer Ends Hand LabelingCalifornia Advanced LabelingThe TubeWriter 2.0 is a direct printer for laboratory media, including micro-centrifuge tubes, cryogenic vials, clus-ter tubes, plates, slides and glass vials. Information is entered in an Excel spreadsheet on a networked or standalone Mac or PC and printed by the TubeWriter with the current alco-hol- and water-resistant ink used in laboratories. Tubes and samples may be printed 40 at a time in as little as 3 minutes. Because no adhesive labels are used, tubes may be placed in liquid N2, -80 C freezers, boiling water, or microcentrifuges without the printing coming off. Printing may be made on the tops or sides of media.

California Advanced Labeling650-906-5600www.tubewriter.com

A more native environment means more relevant dataPlatypus technologiesPlatypus Technologies announces the addition of the Oris Cell Invasion Assay Kit , 96-well format, to its prod-uct line of cell-based assays. This assay allows researchers to view cells invading into a 3-Dimensional, Basement Membrane Extract (BME) in real-time by using a microscope or digital imaging system. Invasion can be quantitated in the same well by staining cells and using a plate reader. The Oris Invasion Assay kit is supplied with an Oris BME coated 96-well plate, Oris BME solution, unique Oris Cell Seeding Stoppers, Oris Stopper Tool, and Oris Detection Mask. Unlike invasion assays using BME coated, cell culture membrane inserts, the Oris Invasion Assay does not require the cells to pass through a membrane. The Oris Cell Seeding Stoppers create a 2 mm detection zone where adherent cells cannot invade until after the stoppers are removed. Seeded cells are overlaid with BME to create a 3-D matrix. This creates a more physiologically rel-evant environment for cell invasion and allows for real-time monitoring of cells producing true invadopodia into the detection zone.

Platypus Technologies608-237-1270www.platypustech.com

Rapid, Multi-mode Automated Cell Imaginginnovatis Inc. The Cellavista is an image-based system that can be used for rapid visualization of a broad range of cel-lular assays, while performing image

analysis simultaneously. Combining brightfield and fluorescence optic capabilities, Cellavista enables users to acquire and analyze images for a wide array of cell-based assays includ-ing but not limited to single cell clon-ing, cell confluence, suspension cell count, FACS seeding efficiency control, cell nuclei count and characterization, transfection efficiency, microplate quality control, viral plaque assays, fluorescent protein expression, and apoptosis assays. In as little as five minutes, Cellavista can scan a 96-well microplate with simultaneous image acquisition and analysis. Cellavista

works with microplates, microscope slides, chamber slides and culture dishes. Automated image stitching capabilities enable complete whole-well analysis as one image. Gating capabilities give the user the power to select specific objects and colonies of interest. The automation-friendly design allows for integration with robotic plate loaders and automated incubators for smooth operation 24 hours a day, seven days a week.

Innovates Inc.800-286-1631www.innovatis.com/cellavista

Easy-to-use compact centrifugesartorius stedim BiotechCentrisart A -14 is a high-speed microcentrifuge for use with standard microfuge and PCR tubes. It fea-tures a selection of rotors for 12-24 0.2 – 2.2 ml tubes and adapters for individual and strip–format PCR tubes.

Operation is simple and logical with a large clear digital display for time and speed/relative centrifugal force (RCF); and push-button short-run, softstart and softstop functions. The Centrisart A-14 runs smoothly and quietly. Maximum speed is 14,800 rpm with a wide RCF range of 2 – 16,163g. The centrifuge is air-cooled, ensuring mini-mal temperature increase during oper-ation. Centrisart A-14 is ideal for use with VoluPAC biomass determination tubes and Vivaspin 500 Ultrafiltration Concentrators and provides any labora-tory with an easy-to-use, powerful and economical benchtop microcentrifuge.

Sartorius Stedim Biotech877-452-2345www.sartorius-stedim.com

Improved gel Electrophoresis AnalysisgE HealthcareGE Healthcare has introduced version 7 of the ImageMaster 2D Platinum, a software package for comprehensive visualization, exploration and analysis of 2-D gel data, including 2-D DIGE. With interactive analysis modes and an improved user interface, version 7 offers significant new features for greater convenience and speed. Key features of ImageMaster 2D Platinum

A D V E R t I s E R ’ s I n D E x

Applied Biosystems, Inc. ....................... 32 www.appliedbiosystems.com

Asuragen, Inc. ....................................... 15 www.asuragen.com

Bentham Science Publishers Ltd. .......... 24 www.bentham.org

Cambridge Healthtech Institute ............ 25 www.chi.com

Chemical Abstracts Service ................... 13 www.cas.org

Cogenics, Division of Clinical Data .......... 5 www.clda.com

Dionex Corporation ................................. 3 www.dionex.com

EMD Chemicals, Inc. ............................. 23 www.emdchemicals.com

Guava Technologies, Inc. ....................... 28 www.guavatechnologies.com

Hamilton Company .................................. 9 www.hamiltoncompany.com

IBC Life Sciences, Inc. .......................... 29 www.ibclifesciences.com

Invitrogen......................................... 17,21 www.invitrogen.com

LEAP Technologies .................................. 7 www.leaptec.com

Molecular Devices, now part of MDS Analytical Tech .... 8,18 www.moleculardevices.com

Platypus Technologies, LLC .................... 14 www.platypustech.com

R&D Systems, Inc. ................................ 27 www.RnDSystems.com

Roche Applied Science ........................... 2 www.roche-applied-science.com

Society for Biomolecular Science ..... 11,19 www.sbsonline.org

Thermo Fisher Scientific ....................... 31 www.thermo.com

Drug Discovery News (USPS 024-504) is published monthly by Old River Publications, LLC, 19035 Old Detroit Road, Suite 203, Rocky River, OH 44116; 440-331-6600. Periodical postage paid at Cleveland, Ohio and additional mailing offices. Publisher assumes no responsibility for unsolicited material or prices quoted in the magazine. Contributors are responsible for proprietary classified information.

©2008 by Old River Publications. All rights reserved. Reproduction, in whole or in part, without written permission of the publisher is expressly prohibited. Back issues, when available, cost $7 each within the past 12 months; $12 each prior to the past 12 months. Back orders must be paid in advance by check.

Drug Discovery News is distributed without charge in North America to qualified drug discovery research professionals. Paid subscriptions to those not qualified cost $65 annually to the U.S. and Canada and $150 to all other countries. All payments must be made in U.S. funds drawn on a U.S. bank.

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For subscription services, including subscription information, please call 215-785-5196.POSTMASTER: Send address changes to Drug Discovery News, PO Box 3100, Langhorne, PA 19047-8800.

v7.0 include: Well-established meth-ods for all 2-D experiments, including single stain and DIGE experiments, easy import and image viewer func-tionality, effective spot detection and matching solutions, versatile analyti-cal methods, user-friendly and flex-ible interface, adaptable visualiza-tion tools, seamless integration into laboratory workflow and quality and data integrity. The ImageMaster 2D Platinum software uses a patented co-detection algorithm to analyse 2-D DIGE (2-D fluorescence difference gel electrophoresis) results. The 2-D DIGE system offers significant cost and time-saving benefits in compari-son with classical 2-D electropho-resis, and allows the simultaneous separation and comparative analysis of up to three samples on a single 2-D gel.

GE Healthcare800-526-3593www.gelifesciences.com/imp

Optical sensing Device Makes Multi-point sampling simpleOcean OpticsJaz is a family of stackable, modular and autonomous components that share common electronics and com-munications. At its heart is a minia-ture CCD-array spectrometer, avail-able with user-selected grating and slit options optimized for a variety of application needs, in a design that accommodates up to 8 spectrometer channels. Each Jaz stack includes a powerful microprocessor and dis-play, so that full spectra data can be acquired, processed and stored onboard the unit—without the need for a PC. Spectral data also can be transferred to a laptop or desktop PC for additional post-acquisition pro-cessing, such as displaying x-axis val-ues in wavenumbers or nanometers or combining data from multiple spec-trometer channels in a single graph.

Jaz systems can be configured for a variety of absorbance, reflectance and emission measurements.

Ocean Optics Inc.727-733-2447www.OceanOptics.com

CLE E. coli, MDs42recAtrfAscarab genomicsMDS42recAtrfA. In our Multiple Deletion Strain 42 Competent Cell Line, we have removed the recA gene for more accurate cloning. The recA protein is responsible for the facilita-tion of DNA recombination and with

the removal of this protein from the cell; we have increased the overall stability of the MDS42 genome and plasmids introduced into it. The trfA protein is responsible for the initia-tion of replication of plasmids con-taining the oriV origin of replication. By use of tightly regulated promoter controlling the trfA gene, the plas-mid replication can be controlled within the cell, giving the research-er more control over plasmid copy number. Along with the removal of Insertion Sequence (IS) elements, our MDS42recAtrfA cells increase clone stability within the cell which provides for more precise cloning. Combine these features with the only sequenced genome with nones-sential genetic elements removed, along with improved transformation efficiencies, researchers can expect great results from these cells.

Scarab Genomics888-513-7075www.scarabgenomics.com

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Applied Biosystems, the most trusted name in PCR instruments, introduces a new line of innovative thermal cyclers. The Veriti™ Thermal Cycler is available in four formats to suit your thermal cycling

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To learn more about the Veriti™ Thermal Cycler or to view the product video, visit info.appliedbiosystems.com/veriti

NOTICE TO PURCHASER:The Veriti™ Thermal Cyclers are covered by patents owned by Applera Corporation. No right is conveyed expressly, by implication, or by estoppel to apparatus, reagents, kits, or methods such as the patented 5’ nuclease methods. For further information contact the Director of Licensing, Applied Biosystems, 850 Lincoln Centre Drive, Foster City, California 94404, USA. © 2008 Applied Biosystems. All rights reserved. Applera, Applied Biosystems, AB (Design) and GeneAmp are registered trademarks and VeriFlex and Veriti are trademarks of Applera Corporation or its subsidiaries in the US and/or certain other countries.

NEW Veriti™ Thermal Cycler


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