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Euro Biofairs Compass –guide to life sciences events

EuropeanBiotechnology

Science & Industry News

Summer Edition 2014 | Vol. 13 | 10.00 € | ISSN 1618-8276 | A 60711 |

CENTRAL EUROPENovartis increases its lead in wet-AMD with take over

NORTHERN EUROPE

Finnish government tables bioeconomy investment strategy

WESTERN EUROPE

Topotarget A/S and Bioalliance Pharma form Onxeo

SOUTHERN EUROPE

Molmed’s gene therapy misses endpoint in pivotal study

EASTERN EUROPE

Czech Sotio pushes immuno-oncologic cell therapy to Phase III

SCIENCE & TECHNOLOGY

New probes enable real-time imaging of cytoskeleton dynamics

Clinical trials data – raw or redacted?

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Research and innovation models are changing dramatically. The emer-gence of platforms such as advanced

therapeutics is accelerating a change from innovation within big centres and universi-ties to smaller, decentralised and more focused units. Innovation is always highest where there is freedom to be creative. An EBE member company CEO whom I know put it very suc-cinctly: “The moment my CSO knows what’s going on in the lab, we are no longer creating new innovation.” The biopharmaceutical eco-system has grown infinitely more diverse, with a wide variety of participants contributing to nearly every aspect of development. Networks and collaborative research establishments were originally seen as a supplement to innovation, but now they have begun generating more core innovation, and are viewed as essential. Con-sidering the fact that most European healthcare biotech companies in the fragmented European innovation landscape are SMEs (70% of the 2,000 healthcare biotech companies in Europe have less than 50 employees), we now desper-ately need efficient networks of innovators from science, business and public institutions to facilitate funding and enablement. There has been a paradigm shift in attitudes towards generating innovation, and this means that all stakeholders need to begin working together much more closely – all the way from the lab to the shelves of pharmacies.

The ultimate drivers in this scenario, of course, are the return on investment and the return on health. We have seen a high return on the funding and time committed to networks that have a specific focus, with the understand-ing that innovation now no longer necessarily comes from our own laboratories.

A critical point is that both partners in a partnership have to benefit. Networks help to

foster mutual trust, particularly where histor-ically there has been a mutual mistrust, a situ-ation largely born of differences in operational cultures. But the Innovative Medicines Initia-tive (IMI) and its successful continuation have demonstrated that these cultural gaps can also be overcome for the greater benefit of patients. Needless to say, partnerships need to demon-strate win-win, and public authorities can help encourage that. Partnerships can work to create a platform of mutual trust and benefit, just as the IMI forges programmes that foster innova-tion with reduced politics, creating a founda-tion for increased trust to flourish.

To support all of these aspects, EBE recent-ly launched a partnership with the European Bio technology Network (EBN) to facilitate EBE member companies’ access to diverse networks and funding opportunities across Europe. This move is aimed at helping them to build partner-ships out of their comfort zone, and deliver dis-ruptive innovation in the future. I am delight-ed with this collaboration, not least because it truly demonstrates the delivery power of effi-cient networking.

As we move forward through 2014, the two networks will bring their members together through the auspices of Horizon 2020, the IMI, and many other funding opportunities, allow-ing them to discover common goals around which they can combine their specialist tech-nology platforms. From SMEs to large com-panies to universities – the lure of creating ex-citing science and business is the perfect cata-lyst for partnership. And as barriers between sectors and organisations fall, the results can only be positive for participants and Europe as a whole. B

Euro|Biotech|NewsSummer Edition | Volume 13 | 2014 3

Intro

Editorial

Efficient R&D networks based on innovation ecosystems

roberto Gradnik, President of European Biopharmaceutical Enterprises, EBE

roberto Gradnik, Strategic Board Advisor and former Chief Executive officer of Stallergenes, has also been the President of the European Biopharmaceuticals Enterprises (EBE) since January 2012. From 2004-2010 he served as President of the Italian biotech industry association Assobiotec. trained as a physician, Gradnik has more than 25 years of experience in the pharmaceuticals and bio-technology sectors. Prior to his current post, he held senior positions at BASF subsidiary Knoll Group and Serono/Merck Serono.

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CIRCULATION

European Biotechnology News is published in co-operation with the following organisations:

Europe: european-biotechnology.net Switzerland: swissbiotech.org

EuroBiotechNews covers the biotechnology sector of the current 28 EU member states, Norway and Switzerland. If you would like to subscribe, please refer to

www.eurobiotechnews.eu

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Finland: fi nbio.net

Euro|Biotech|NewsSummer Edition | Volume 13 | 2014 5

contEntS

InSIght

EC tailwinds for mobile health; GMO deadlock set to continue; Heard in Brussels 10

EU action plan aims to reduce medication errors 12

Adverse drug effect numbers peak; IP Flash 14

REgulatoRy affaIRS

Update on clinical trials 20

Breaking news from the EMA 22

EconomIc

Focus on newsflow and dividends 23

Stock markets 24

PERSPEctIVES

BIO 2014: Heading to the world’s most important biotech event; Finding European partners in the EU health competence database 15

Interview: Madiha Derouazi, Amal Therapeutics SA 60

REgIonal nEwS

Northern Europe 26

Central Europe 28

Western Europe 30

Eastern Europe 32

Southern Europe 34

Imprint European Biotechnology News is published monthly by: BIOCOM AG, Lützowstr. 33–36, D-10785 Berlin, Germany, Tel.: +49-30-264921-0, Fax: +49-30-264921-11, E-Mail: service@eurobiotechnews.eu; Internet: www.eurobiotechnews.eu, Publisher: Andreas Mietzsch, Editorial Team: Thomas Gabrielczyk (Managing Editor), Derrick Williams (Co-editor), Dr. Patrick Dieckhoff, Uta Mommert, Dr. Martin Laqua, Benjamin Stolzenberg; Advertising: Oliver Schnell, +49-30-2649-2145, Christian Böhm, +49-30-2649-2149; Distribution: Marcus Laschke, +49-30-2649-2148; Printed at: Druckhaus Humburg, Bremen; Graphic Design: Michaela Reblin. European Biotechnology Science & Industry News is only regularly available through subscription at BIOCOM AG. Annual subscription fees: € 100.00, Students € 50.00 (subject to proof of enrolment). Prices include VAT, postage & packaging. Ordered subscriptions can be cancelled within 2 weeks directly at BIOCOM AG. The subscription is initially valid for one year. Subscriptions will be renewed automatically for one more year, respectively, unless they are cancelled at least 6 weeks before the date of expiry. Failures of delivery which BIOCOM AG is not responsible for do not entitle the subscriber to delivery or reimbursement of pre-paid fees. Seat of court is Berlin, Germany. As regards contents: individually named articles are published within the sole responsibility of their respective authors. All material published is protected by copyright. No article or part thereof may be reproduced in any way or processed, copied and proliferated by electronic means without the prior written consent of the publisher. Cover Photo: © fotopak/Fotolia.com. Supplements: BIOM Biotech Cluster Development, ASEBIO ® BIOCOM is a registered trademark of BIOCOM AG, Berlin, Germany.

Clinical trials transparency: EMA accused of U-turn 6

Cover Story

SERVIcES

Partners & Associations 4

Biopeople News from GenSight Biologics SA, AMSilk GmbH, Merck Millipore, Ario Pharma Ltd, Tiziana Life Sciences plc. and Ergomed Clinical Research Ltd 62

Company index 64

Events What’s on in Summer 2014 65

Encore 66

SpeCial

Euro Biofairs Compass Europe’s non-stop biotech calendar 37 Life Sciences Baltics, Vilnius 38 Biospain 2014; S. de Compostela 40 EFIB 2014, Reims 42 European Biotech Week, EU 44 CPhI 2014, Paris 46 BioJapan, Yokohama 48 Bioinnovation, Gdansk 50 Bio-Europe, Frankfurt/Main 52 56th EuroPLX, Nice 54 Pharmalab, Düsseldorf-Neuss 56 Munich Biomarker Conference 58

for years, Europe’s drug regulators pushed for the proactive publication of results from clinical trials. as the Ema prepares to present its new policy in the area, however, it has come under fire from health technology assessors and the European ombudsman, who say the planned rules could make transparency even worse. the guidelines foresee al-lowing companies to redact “commercially confidential” information, while requiring researchers to sign agreements not to publish or disseminate some of the data.

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INSIGHT EUROPE

Claire Skentelbery, Secretary General of the European Biotechnology Network

Heard in BrusselsM Europe’s hungry biotech sector

Brussels – The launch of Horizon2020 and close of the first deadlines in February has shown the appetite of Europe’s research-ers from industry and academia for fund-ing. A huge number of applications were received, particularly for the two-stage applications, where success rates are as low as 4% for some topics. And pass rates could remain low even at Stage 2.

A silver lining

This is scary news at first glance, but we have to look at it in multiple ways. First, these were the first deadlines after a break between FP7 and H2020, so people had been waiting awhile for the Framework carousel to start turning again. Second, the two-stage application process opens the door to a huge number of specula-tive attempts at Stage 1, where the appli-cation is short. In some ways it’s annoy-ing to think a half-developed idea could beat a carefully crafted effort. Indeed, ex-actly that has happened to enough EBN Member proposals.

Feeding the European fire

When you look at the big picture, how-ever, you have to feel positive. Hori-zon 2020 is highly focussed on exploita-tion and raised impact. If evaluators are spoiled for choice with proposals that can deliver economic returns from biotech, then we can’t complain too much. Good-ness knows Europe needs to deliver mon-ey back into the system from maturing biotechnology. I’m not talking about the kind of money that comes from the acqui-sition of an SME for a fraction of the pub-lic money that has been poured into mak-ing it ripe for purchase, but the genuine maturation of value within Europe. These short Stage 1 proposals also enable people new to EC funding to dip a toe in the wa-ter. Much better a failed Stage 1 proposal

AgriBiotecH

Permit deniedA Brussels – Although more and more EU Member States are considering opting out of planting GMO acreage on their own ter-ritory, the new opportunity to ban GM crops isn’t slowing down attempts to import them. At the end of May, three applications for the import of genetically engineered soybean strains did not receive the required quali-fied majority in the Standing Committee on the Food Chain and Animal Health (SCFC-AH). The decision on whether to approve a herbicide-tolerant soybean from BASF (BPS-CV127-9) and two soybeans that lead to beneficial fatty acid profiles (Pioneer’s soybean 305423 and Monsanto’s Mon88705) have been now been forwarded to the Ap-peals Committee. If it is unable to reach the required majority, the Commission can de-cide to approve on its own. B

HeAltHcAre Budgets

e-AgeingA Brussels/Athens – EU Health Commis-sioner Tonio Borg has called for more use of wireless devices in monitoring chronic dis-eases. Speaking in mid-May at the eHealth Forum 2014 in Athens, he said telemedicine and the current 100,000 healthcare apps on mobile phones are tools that can help pro-mote eHealth. According to estimates from the European Commission (EC), the impact of mobile health (mHealth) on EU health-care systems could be significant. EC Vice-President Neelie Kroes says mHealth could save a99bn annually by 2017 if its potential is fully unlocked. In April, Kroes launched the MobiGuide project, which provides per-sonalised clinical-guideline-based guidance outside clinical environments to cardiac and diabetes patients. “mHealth has great po-tential to empower citizens to manage their own health and stay healthy longer, to trig-ger greater quality of care and comfort for patients, and to assist health professionals in their work,” said Borg. B

that gets you thinking about working in partnership and moving your technology forward than no effort at all because a full proposal was too difficult. Failed Stage 1 proposals need to keep their chins up – after all, you’ve started a journey, found some new friends and there are many ad-ventures that beckon.

From small beginnings

The big question coming up is how the new SME Instrument performs. Part of me trembles at the thought of how many applications are cooking and how many will be disappointed. The rest of me is ex-cited – at last, something to drive SMEs forward, masters of their own destiny! We’re cautiously circling the first dead-lines in June, and I would imagine that the EC is also waiting with terror in its heart so see what the application proc-ess yields, and whether they’ll have to get extra USB sticks out of the cupboard to store all the applications. If you feel any tremors in cyberspace on June 25, you will know the SME Instrument has delivered a bouncing big baby into the nervous arms of its midwife. B

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medication errors

European agencies take action to address a widely perceived danger

12 Euro|Biotech|News Summer Edition | Volume 13 | 2014

INSIGHT EUROPE

A London/Brussels – In the US, medica-tion errors are estimated to cause a stun-ning 400,000 deaths a year, making them the third leading cause of death there. Eu-ropean data suggest that medical errors and healthcare-related adverse drug re-actions (ADRs) occur in 8% to 12% of all hospitalisations, and cause about 850,000 adverse events a year. While accurate fig-ures are hard to determine, four out of five EU citizens on average perceive med-ication errors as a prominent problem in their country, according to a 2006 Euro-barometer survey. What’s more, medica-tion errors are “the single most common prevent able cause of adverse events in medication practice,” according to the Eu-ropean Medicines Agency (EMA). Togeth-er with EU national competent authorities, the EMA agreed an action plan to address the problem in late April.

Based on discussions with over 200 stakeholders in the field, the agencies’ strategy focuses on improving reporting of ADRs as a prerequisite for risk minimi-sation and prevention strategies. The ac-tion plan includes recommendations that are to be implemented by autumn of 2015, among them:

– the implementation of a good practices guide, including common rules for cod-ing and reporting medication errors as well as data-sharing,

– the establishment of a good practice guide on risk minimisation and preven-tion of medication errors, including spe-cific patient subgroups such as children and geriatric patients.

– the development of an EMA concept paper on the best use of the Medi-cal Dictionary for Regulatory Activi-ties (MedDRA) terminology to address medication -error specific coding, data retrieval and analysis issues.

– raising awareness and implementing a communication strategy as part of the European Commission’s Joint Action ‘Strengthening Collaboration for Op-erating Pharmacovigilance in Europe' (SCOPE)

The EMA and the national Agencies also want to improve contact between them-selves as well as with patient/consumer groups as well as healthcare professionals to assess and systematically prevent risks associated with medication errors through-out a pharmaceutical product’s entire life-cycle. D

newsM Food matters

Brussels – A 70% decline in cardio-vascular deaths in Denmark follow-ing a ban of trans fats has provided more strong evidence that lifestyle and diet can significantly impact health outcomes. In April, the European Commission launched the first trans-national call of its novel Joint Program-ming Initiative ‘A Healthy Diet for a Healthy Life’ (JPI HDHL). This fund-ing round will focus on the validation of biomarkers that indicate nutrition-al effects in the development of foods. Selected projects will be announced in October. Kick-off is in December.

M EU synergies

London – The European Chemicals Agency (ECHA) and European Med-icines Agency (EMA) are joining forc-es in predictive toxicology, measuring the environmental impact of pharma-ceuticals, and defining maximum res-idue limits for pharmacologically ac-tive substances. In mid-May, EMA chief Guido Rasi and ECHA-head Geert Dancet signed a memorandum of understanding on the partnership.

M Taking the EC to court

Stockholm/Brussels – Sweden is sueing the European Commission for its delay in defining scientific criteria needed to identify and ban hormone-like substances in prod-ucts that affect human health and the environment. According to Envi-ronment minister Lena Ek, the Com-mission missed a December 2013 deadline to provide testing criteria. To speed up the process, her govern-ment will now take the case to the European Court of Justice.

Table 1: Incidence of medication errors in Europe

Stage in the medica-tion use system

Ambulatory care

Hospital Comments

A Prescribing 7.5% 0.3-9.1% % of medication orders

A Dispensing 0.08% 1.6-2.1% % of medication orders

A Administration Not available49.3%5.1-47.5%

2.4-8.6%

7.2-9.1%

10.5%

2.4-9.7%

Direct observation studies:– IV medicines dose prepared on wards– Traditional floor stock or ward stock

systems– Ward stock system with original

prescription and daily ward visits by pharmacists

– Patient prescription distribution systems

– Unit dose drug distribution manual system

– Unit dose drug distribution, computerised or automated system

©EM

A

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64 Euro|Biotech|News Summer Edition | Volume 13 | 2014

Company and adVErtiSEr indEx

AB-Biotics (E) …………………………………… 34Abbott GmbH & Co KG (GER) ………………… 20Ablynx NV (B) ………………………………… 20AC Immune SA (CH) …………………………… 28ADC Therapeutics (CH) ……………………… 20Amakem NV (B) ………………………………… 21Amal Therapeutics S.A. (CH) ………………60, 61Amega Biotech (AR) …………………………… 46Amgen Inc. (USA) ……………………………29, 62AMSilk GmbH (GER) …………………………… 62Andelam B.V. (NL) ……………………………… 32Arcticzymes AS (N) …………………………… 26arGEN-X B.V. (NL) ……………………………… 29Ario Pharma Ltd. (UK) ………………………… 62ASEBIO – BIOSPAIN 2014 (E) 40, 41, SupplementAstraZeneca AB (S/UK)………………………20, 30Barentzymes AS (N) …………………………… 26BASF SE (GER) ……………………………… 3, 10Bayer Healthcare AG (GER) …………………… 28Bayer Pharma AG (GER) ……………………… 29Bio-Tech Consulting (PL) ……………………… 33Bioalliance Pharma SA (F) …………………… 30BIOCOM AG (GER) …………………… 13, 60, 61Biogen Idec (USA) ……………………… 20, 22, 27Bioiberica S.A. (E) ……………………………… 34BioM GmbH (GER) ………………58, SupplementBiomedal S.L. (E) ……………………………… 34BIOPOLIS S.L. (E) ……………………………… 34biosaxony e.V. (GER) – Bionection 2014 …… 27Biosearch Technologies (E) …………………… 34Biosidus (AR) …………………………………… 46BioTOP Berlin-Brandenburg (GER) …………… CP3Biovex (USA) …………………………………… 62Bloomberg (USA) ……………………………… 23BOEHMERT & BOEHMERT (GER) …………… 17Boehringer Ingelheim (GER) ………… 20, 21, 60Burrill & Company (USA) ……………………… 33Calico GmbH (GER) …………………………… 28Changchun BCHT Biotechnology Co. (VRC) … 31Chelsea Therapeutics (USA)…………………… 26Cobra Biologics (UK) …………………………… 21Coca-Cola (USA) ……………………………… 42CombinatoRx (UK) …………………………… 31Complix N.V. (B) ……………………………… 62Concept Heidelberg (GER) – PharmaLab 2014 56, 57Cosmo Pharmaceuticals (I) …………………… 62Covagen AG (CH) ……………………………… 21Dainippon Sumitomo Pharma Co. Ltd. (JP) … 26Dako A/S (DK) ………………………………… 26DSM (NL) ……………………………………… 42e-Therapeutics plc (UK) ……………………… 20EBD Group (GER) – BIO-Europe 2014 ……52, 53Eli Lilly (USA) …………………………… 20, 21, 29Enterprise Lithuania (LT) ……………………… 38Ergomed Group (UK) ………………………… 62Eupharmed (I) ………………………………… 34EuropaBio (B) – European Biotech Week …44, 45European Biotechnology Network (B) ………… 16ExonHit (F) ……………………………………… 62Fördergesellschaft IZB (GER) …………………… 7Fournier-Solvay Pharma (F) …………………… 62Fovea-Sanofi (F) ……………………………… 62Galderma SA (F) ……………………………… 62Gedeon Richter Ltd. (HUN) …………………… 32Genmab A/S (DK) ……………………………… 21GenSight Biologics (F) ………………………… 62Genzyme (USA) ………………………………… 38GlaxoSmithKline (UK) ……………………… 21, 38Glycotope GmbH (GER) ……………………… 23GW Pharmaceuticals (UK) …………………… 23Hessen Trade & Invest GmbH (GER) ………… 52High-Tech Gründerfonds Management (GER) 23, 60

Horizon Discovery Ltd. (UK) …………………… 31Hospira One 2 One Global Pharma (USA) …… CP4ICS Convention Design Inc. (J) ………………48, 49Immunocore Ltd. (UK) ………………………… 62Kymab Ltd. (UK) ……………………………… 31Life Science Austria LISA (A) …………………… 36Lundbeck A/S (DK) …………………………… 26Lysogene SAS (F) ……………………………… 31Mabion S.A. (PL) ……………………………… 46Medimmune Ltd (UK) ………………………… 20Merck KGaA (GER) …………………………… 38Merck Millipore (GER) ………………………… 62Merck Serono (CH) ……………………………… 3Mitsubishi Tanabe Pharma (JP) ……………… 21MLM Medical Labs GmbH (GER) ………………… 9MolMed S.p.A. (I) ……………………………… 34Monsanto (USA) ……………………………… 10Mucosis BV (NL) ……………………………… 31NATAC (E) ……………………………………… 34NatureWorks LLC (USA) ……………………… 42Newron Pharmaceuticals S.p.A. (I) …………34, 62Nicox S.A. (F) …………………………………… 34nova-Institut (GER) – 3rd Conference on CO … 59Novartis AG (CH) ……………………………29, 62NovImmune S.A. (CH) ………………………… 23Novo Nordisk A/S (DK) ………………………… 29Novo Seed (DK) ……………………………… 31Ophtotech Inc. (CH) …………………………… 29Orphan Biovitrum (S) ………………………… 20Oxford Immunotec (UK) ……………………… 23Parexel (USA) …………………………………… 38Pevesa Biotech SA (E) ………………………… 34Pfizer Inc. (USA) ………………………………… 30Pierre Fabre Oncology Laboratories (F) ……… 62Pioneer Hi-Bred International Inc. (USA) …… 10Piramal Imaging SA (CH) ……………………… 28PowderMed Ltd (UK) ………………………… 62PPF Group (HUN) ……………………………… 32Pro Science Polska – Bioinnovation 2014 (PL) 50, 51Pro-Science Poland Ltd. ……………………… 50Promocell GmbH (GER) ……………………… 64Provitro GmbH (GER) ………………………… 28Qiagen NV (GER) ……………………………… 29RauCon (GER) – EuroPLX ……………………54, 55Rentschler Biotechnologie GmbH (GER) …… 19Roche AG (CH) ………………………………… 21Salans FMC SNR Denton Europe LLP (GER/USA) 11Selvita S.A. (PL) ………………………………… 33Seprox Biotech (E) ……………………………… 34Shire plc (IRL) …………………………………29, 62Smithers (UK) – EFIB Conference 2014 ……42, 43Sobi AB (S) ……………………………………… 27Sofinnova (F) …………………………………… 31Sotio a.s. (CR) ………………………………… 32STALLERGENES SA (F) …………………………… 3Sterne, Kessler, Goldstein & Fox (USA) … CP2, 14Südzucker AG (GER) …………………………… 42SV Life Sciences (UK) ………………………… 29Swiss Healthcare Investments Ltd. …………… 29Teva Pharmaceutical Industries Ltd. (IL) ……33, 38TherapeuticProteins International …………… 46Tiziana Life Sciences plc (UK) ………………… 62Topo Target A/S (DK) ………………………… 30Toscana Promozione (I) ……………………… 15Toxicon Corp. (USA) …………………………… 46Trophos SA (F) ………………………………… 20TxCell S.A. (F) …………………………………… 31UBMi B.V (NL) – CPhi worldwide ……………46, 47Unilever (CH) …………………………………… 42uniQure BV (NL) ……………………………… 23ZAMBON Company S.p.A. (I) ………………… 34

A Heidelberg – PromoKine offers a wide range of products for cell analysis, includ-ing numerous kits for fast, convenient and sensitive measurement of cell viability/pro-liferation, cytotoxicity, cell death and ap-optosis, cell stress and metabolism, as well as reporter gene expression. PromoKine’s Fluoro metric Cell Viability Kits are based on resazurin or calcein-AM conversion, while the Colorimetric Cell Viability Kits utilise reduction of different tetrazolium salts. The Bioluminescent Cell Viability Kits measure ATP levels as a marker for cell viability in a luciferase assay, and the Cell Proliferation

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