VOLUME 21 ISSUE 9 APRIL 2004

BUSINESS BRIEFS 121

BLOOD & BIOTECHNOLOGY 126

RESEARCH & DEVELOPMENT 127

PLASMA FRACTIONATION NOTES 129

PRODUCT SAFETY UPDATE 130

PEOPLE 130

NEW PRODUCTS 131

RECENT U.S. PATENTS 132

MEETINGS / SUBSCRIPTION FORM 135

____________________COMPANIES IN THIS ISSUE__________________

AABB PRESSABBOTT LABORATORIESALPHA THERAPEUTICAMERICAN RED CROSSAMGENAVENTIS BEHRINGAVENTIS BIO-SERVICESAVENTIS SABioLife SolutionsbioMérieux IndustryBioTimeCANGENECHUGAI SEIYAKUCLONEX DEVELOPMENTCORIXACSL BIOPLASMACSL LIMITEDDADE BEHRING MARBURGELAN DRUG DELIVERYELI LILLYGAMBRO BCTGENETICS INSTITUTE

GERMAN RED CROSSGRIFOLS SAHAEMONETICSINNOGENETICSKAMADALFBMITSUBISHI PHARMANATIONAL BLOOD SERVICE (UK)NIPPON ZOKINORTHFIELD LABORATORIESNOVO NORDISKOCTAPHARMAPHARMACIAPPTAPROBITAS PHARMAProMetic Life SciencesSIENCOSIRE ANALYTICAL SYSTEMSXENCORZLB BEHRINGZLB BIOPLASMAZLB PLASMA SERVICES

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BUSINESS BRIEFS

* CSL LIMITED completed its acquisition of AVENTIS BEHRING from AVENTIS SA on March 31, and will combine it with its own ZLB BIOPLASMA business to create ZLB BEHRING. Aventis will receive total proceeds of up to $925 mil-lion, comprising a cash payment of $550 million, deferred payments totaling $125 million, and up to $250 million in four years based on CSL’s share price performance. Major assets include fractionation plants in Germany (Marburg), Austria (Vienna) and Kankakee, Illinois, all of Aventis Behring’s intellectual property, 68 U.S. and German plasma collection centers, and plasma-related activities in Japan. CSL BIOPLASMA, the company’s Australian-based plasma therapeutics subsidiary, will continue to manufacture products primarily for its domestic market, and will remain a separate operating unit. ZLB Behring headquarters and business operations will be consolidated in King of Prussia, Pennsylvania.

This merger joins ZLB Bioplasma’s advanced IVIG production technology with Aven-tis Behring’s broad line of coagulation products, hemophilia expertise and specialty products, according to a senior ZLB Behring official. “Today’s plasma products in-dustry demands a broad portfolio of quality products, an innovative R & D pipeline, an efficient high yield production operation, the ability to balance market demands and outputs and a global marketing effort,” a senior CSL official noted. “ZLB Behring is well positioned to realize all of these key attributes,” he added.

* Small, focused teams will work to effect the integration of the manufacturing, distribution, plasma sourcing and other operations of ZLB BIOPLASMA and AVENTIS BEHRING over the next 18 months, according to a senior ZLB BEH-RING official. In its appraisal of manufacturing activities in particular, the company says it will consult closely with physicians and patients, to assure a reliable supply of high quality products.

While most decisions await appraisals by “integration teams” working together with line management, ZLB Behring has shared the following plans with International Blood/Plasma News:

• Production of IVIG at the Kankakee, Illinois plant will likely be reduced to adjust to an oversupply situation in the U.S. market;

• Pending regulatory approvals, some Fraction II intermediate material will be shipped from the Kankakee plant to the fractionation facility in Bern, Swit-zerland for processing into IVIG;

• Earlier announced plans to convert IVIG production at the Bern facility to chromatography-based purification by 2006-2007 remain in effect;

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• The headquarters offices for the combined ZLB PLASMA SERVICES and AVENTIS BIO-SERVICES plasma collection operations will be based in Boca Raton, Florida; and

• As both CSL BIOPLASMA and AVENTIS BEHRING distribute products in Pacific Rim countries, some rationalization of the distribution structure is anticipated where the company identifies overlapping coverage.

* The Spanish biopharmaceuticals manufacturer PROBITAS PHARMA plans an initial public offering of shares on the Madrid Stock Exchange this summer, according to a company spokesperson cited in Pharma Marketletter. Probitas origi-nally had planned its IPO for October 2002, but those plans to float new shares were suspended. Several positive developments for the company – including last year’s acquisition of Los Angeles-based ALPHA THERAPEUTIC from MITSUBISHI PHARMA and U.S. approval to market its Flebogamma IVIG product – are said to account for its confidence in the timing of this IPO. Probitas is the parent firm of GRIFOLS SA, its plasma fractionation subsidiary.

* In addition to €20 million ($24.2 million) already spent since acquiring it from the French government in 1999, OCTAPHARMA reportedly plans to spend about €20 million more on its production facility at Lingolsheim, near Strasbourg, France. The workforce has climbed from 80 to 250 people, with an annual fractionation capac-ity now standing at 250,000 liters of plasma.

The Lingolsheim facility is authorized to sell several plasma products in France, but production scheduled to order for other national health authorities (mainly Brazil) has grown to account for about one-third of its output. In addition to Lingolsheim, Octapharma operates fractionation plants in Stockholm, Mexico City and Vienna.

* As a theoretical precaution against the spread of variant Creutzfeldt-Jakob dis-ease (the human form of Mad Cow disease), the UK Department of Health has announced that it will defer blood donations from recipients of blood transfusions. This policy will apply to anyone who has received a transfusion after January 1, 1980, as “it is generally accepted that there will have been no exposure to bovine spongiform encephalopathy (BSE) in the UK before that date,” according to the Department of Health. A senior official noted that it is following “a highly precautionary approach,” as transfusion-transmitted vCJD “remains a possibility and not a proven causal con-nection.” The new deferral rule goes into effect on April 5.

The NATIONAL BLOOD SERVICE estimates that about 52,000 donors will be deferred annually, accounting for about 3.2% of all blood donors. To try to minimize the impact of this donor deferral on blood supplies, a new strategy is being designed which builds on the current “Better Blood Transfusion – More Appropriate Use” conservation initiative.

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* In Japan, the following official prices for major blood components are currently in effect, according to the 2003 Reimbursement Pricing Directory:

Whole blood (400 mL) ¥11,504 $104.58

Leukocyte-poor red blood cells (400 mL) ¥15,438 $140.35

Fresh frozen plasma (160 mL) ¥11,014 $100.13

Fresh frozen plasma (450 mL) ¥22,336 $203.05

Platelets (3.0 x 1011) ¥113,190 $1,029.00

Platelets (4.0 x 1011) ¥151,820 $1,380.18

U.S. $1.00 = ¥110

* The government of Vietnam has issued an order to establish a National Institute of Hematology and Blood Transfusion (NIHBT) under the country’s Health Ministry, according to the Viet News Agency. To be located at Bach Mai Hospital’s Institute of Hematology and Blood Transfusion, the new agency will provide specialized medical examinations and treatment, collect, screen and provide blood, manufacture blood products, and conduct scientific research and training.

* One of the GERMAN RED CROSS Transfusion Service Regions has published the following new 2004 prices for selected blood components:

Filtered red cell concentrate (SAGM) € 74.00 $89.50

Filtered platelet dose (4 buffy coat units) €295.00 $357.00

Apheresis platelet dose (leukocyte-poor) €704.00 $852.00

Fresh frozen plasma (quarantined) €0.20/mL $0.24/mL

U.S. $1.21 = €1.00

* The LABORATOIRE FRANÇAIS DU FRACTIONNEMENT ET DES BIO-TECHNOLOGIES (LFB) has recently introduced a new von Willebrand factor concentrate in France. Wilfactin is indicated for the prevention and treatment of von Willebrand disease in patients for whom desmopressin is either ineffective or contra-indicated. Wilfactin is mixed with 10 mL of sterile water to provide 1,000 Ristocetin cofactor units. The production method includes dry heating and nanofiltration steps to effect viral inactivation and removal.

Wilfactin will replace LFB’s Facteur Willebrand LFB-T, and will be priced at €1.06 per Ristocetin cofactor unit. LFB anticipates a wider European roll-out, as individual countries establish reimbursement policies for the product.

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* The Council of Europe has published the 10th edition of its Guide to the Preparation, Use and Quality Assurance of Blood Components. These guidelines are intended to promote the safety, efficacy and quality of blood components. Opponents of manda-tory unpaid donations have objected to the Council’s decision to base its guidelines on the premise of voluntary, non-remunerated blood donations, which was formally endorsed in 2002. Many countries rely on compensated donor bases, and claim that this policy will severely limit the blood supply.

This Guide is the basis for many national guidelines, both in Europe and elsewhere. Below are highlights of changes from the prior edition:

• Chapters on blood group serology and selection of donors have been re-worked;

• Better distinction has been made between testing requirements necessary for whole blood donation and for donation used exclusively for plasma fraction-ation;

• Deferral criteria for West Nile virus have been introduced; and

• A section has been added on designated and directed donations.

* NOVO NORDISK has received approval to market its Norditropin Nordiflex recombinant human growth hormone preparation from the Japanese Ministry of Health, Labor and Welfare. This new product is provided in a prefilled syringe, simplifying the home injection routine by the patient or parent.

* The U.S. FDA has cleared bioMérieux Industry’s BacT/ALERT BPA and BacT/ALERT BPN culture bottles for microbial quality control testing of leukocyte-re-duced apheresis platelets (LRAPs). These new plastic culture bottles are dedicated for use on the BacT/ALERT Microbial Detection Systems for microbial quality control testing of LRAPs. The BPA bottles support the growth of aerobic microorganisms, while the BPN bottles support the growth anaerobic and facultative anaerobic micro-organisms. Through extensive clinical testing, bioMérieux says the plastic bottles demonstrated equivalent performance to the currently supplied glass BacT/ALERT SA and BacT/ALERT SN culture bottles.

Erratum

The website at which the public can access a newly launched clinical blood and marrow stem cell transplant database sponsored by the U.S. National Center for Biotechnology Informa-tion (NCBI), is www . ncbi.nih.gov/mhc. This database is reviewed in a feature that appears in the March 2004 issue of International Blood/Plasma News, page 110. We apologize for the error.

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* The PLASMA PROTEIN THERAPEUTICS ASSOCIATION (PPTA) is reportedly preparing a position paper opposing a planned U.S. FDA guidance that would establish a scientific framework for “generic” follow-on biologics. The industry group argues that each plasma therapy must be recognized as an innovator product and must undergo the full biologic licensing requirements. PPTA further asserts that plasma therapies are made using variable starting materials and biotechnology process that cannot be precisely replicated from one producer to another. Thus the safety and efficacy of biological products cannot be assured through follow-on or bioavailability studies used for generic drugs, according to comments reported in FDA Week.

In a related matter, PPTA was successful in convincing the U.S. Centers for Medicare and Medicaid Services (CMS) to change its classification of IVIG from a multi-source to a sole source product for purposes of defining a Medicare hospital outpatient pay-ment rate.

* Combined intrathecal and intramuscular (IM) administration of antitetanus immune globulin was superior to IM administration alone for treatment of teta-nus, according to findings of a 120-patient randomized controlled trial published in the March 13 issue of BMJ. The IM/intrathecal group had a 20% advantage in the proportion of patients with improvement, and a larger proportions of patients with spasms lasting ≤10 days.

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This study provides an update of the hemophilia care market situation in the United States, with particular focus on:

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BLOOD & BIOTECHNOLOGY

* CORIXA has granted ABBOTT LABORATORIES non-exclusive rights to its recombinant TcF antigen to use in the development of a blood screening assay to detect antibodies to Trypanosoma cruzi, the parasite responsible for Chagas disease. “In studies to date, the TcF recombinant antigen has been able to detect nearly all patients infected with T. cruzi and has avoided many of the problems of false positivity and unreliability associated with older assays that used whole organisms for antibody detection,” a senior Corixa official said. Chagas is a chronic, potentially lethal infection that affects an estimated 16 to 18 million people worldwide, and is transmissible through blood.

* While currently recommended to speed neutrophil recovery after hematopoietic stem-cell transplantation, treatment with granulocyte colony-stimulating factor (G-CSF) after allogeneic bone marrow transplantation (BMT) for acute leukemia may increase the risk of graft-versus-host disease (GVHD) and death, according to a report by Swedish investigators in the Journal of Clinical Oncology. The clinical effects of G-CSF were evaluated after BMT and peripheral blood stem cell transplan-tation from HLA-identical siblings in more than 2,200 patients with acute myeloid leukemia and acute lymphoblastic leukemia.

Among the BMT patients only, G-CSF treatment was associated with an increased risk of acute GVHD (50% versus 39%) and chronic GVHD (37% versus 28%) when compared to control patients not treated with G-CSF. Moreover, patients treated with G-CSF had higher two-year transplant-related mortality (27% versus 17%) and a lower probability of overall survival (48% versus 58%). A delay in platelet engraftment was also documented, offsetting the theoretical benefit of faster neutrophil recovery. Mortality, relapse and leukemia-free survival did not differ according to G-CSF treatment in patients who received peripheral stem cell transplants, the authors noted.

* Earlier treatment of qualifying severe sepsis patients with ELI LILLY’S Xigris activated protein C appear to increase the probability of survival, according to separate studies presented at the annual meeting of the Society of Critical Care Medi-cine. U.S. investigators found that 24 of 29 surviving patients received Xigris within 24 hours of onset of severe sepsis, while only 10 of the 18 patients treated more than 24 hours after onset survived.

Published by: The Marketing Research Bureau, Inc. 284 Racebrook Road, Orange, Connecticut 06477 Phone: (203) 799-0298 Fax: (203) 891-8855 e-mail: mrb_ibpn@earthlink.net

http://home.earthlink.net/~mrb_ibpn

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* Overall mortality associated with administration of 4% human albumin in criti-cally ill patients was no different than the death rate in patients given saline, according to finding from the much-anticipated “SAFE” (Saline vs. Albumin Fluid Evaluation) trial, which was sponsored by various government agencies in Australia and New Zealand. Albumin and saline were manufactured and supplied by CSL BIOPLASMA, and all investigators were blinded to the solution they were infusing. Sixteen participating centers in this largest-ever critical care study enrolled and tabu-lated results from 6,933 trauma, severe sepsis and adult respiratory distress syndrome (ARDS) patients requiring plasma volume expansion. Below are selected highlights from presentations at recent meetings of the Society of Critical Care Medicine (SCCM) and the Network for the Advancement of Transfusion Alternatives (NATA):

• The overall mortality rates were 20.9% and 21.1% for albumin and saline groups, respectively (p=0.866);

• There were no overall differences in other outcome measures including days of mechanical ventilation, renal replacement therapy rate, proportion of patients who developed single or multiple organ failure, ICU length of stay or hospital length of stay;

• The relative risk of death for severe sepsis patients given albumin was 0.87, but the 95% confidence interval included parity;

• In trauma patients without traumatic brain injury (TBI), the death rate was identical in both the albumin and saline groups (6.2%), but in the subset with TBI, there were 21 excess deaths in the albumin group and a strong trend to-ward increased mortality (p=0.055); and

• An average of about 1,600 mL and 1,200 mL of saline and albumin were re-spectively infused over the first four days, yielding a ratio far lower than the 3:1 ratio of crystalloids to colloids widely cited as the standard for use of blood volume expanders.

The impetus for this trial was a highly controversial 1998 meta-analysis published in BMJ by the UK-based Cochrane Injuries Group, which claimed that albumin use in ICU patients with severe burns, hypovolemia or “hypoalbuminemia” was associated with a 68% higher overall mortality risk than patients given saline. Also motivating this trial is the decades-old “crystalloid versus colloid” debate, which never has been addressed in a robust clinical trial. A published report of findings of the SAFE trial will appear shortly in the New England Journal of Medicine, according to reliable sources.

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* Following encouraging findings in a pilot study in the Philippines, CANGENE said it plans to launch a more comprehensive clinical trial to determine whether its WinRho SDF anti-Rh immunoglobulin is efficacious in severe cases of dengue hemorrhagic fever. This condition, which is characterized by fever, an extremely low blood platelet count and spontaneous bleeding, can lead to circulatory failure and shock. Several hundred thousand cases are reported annually worldwide, but only about 7,000 cases in North and South America.

A Cangene spokesperson acknowledged that this clinical application would not rep-resent a substantial business opportunity, but it would improve WinRho SDF’s market presence in some parts of the world. Currently, WinRho SDF is approved and used to prevent hemolytic disease of the newborn (Rh incompatibility) and to treat an autoim-mune disorder known as immune thrombocytopenic purpura (ITP).

* The incidence of febrile nonhemolytic transfusion reactions (FNHTR) to red blood cells decreased from 0.37% to 0.19% with the institution of leukoreduction, ac-cording to investigators at the Johns Hopkins Hospital. Transfusion reaction events in the last six months of 1994, when 96% of the institution’s red blood cell inventory was not leukoreduced, were compared with events in the same period in 2001, when 99.5% of the red cell inventory was leukoreduced:

Percentage of Total Allergic RBC leukoreduced transfusion transfusion Year transfusions RBCs reactions reactions FNHTR

1994 16,246 4.0% 91 (0.56%) 24 (0.15%) 60 (0.37%)

2001 19,916 99.5% 79 (0.40%) 34 (0.17%) 37 (0.19%)

p value 0.024 0.59 0.0008

While leukoreduction of red blood cells appears to have reduced FNHTRs by about half, this special processing step appears to have no effect on the incidence of allergic transfusion reactions. The authors, whose report appears in Transfusion, suggest that, while FNHTRs are generally not life threatening, their management, evaluation and associated blood product wastage makes them costly when they do occur.

Publishers of International Blood/Plasma News© are careful to report accurately from sources believed reliable, but cannot assume liability for any information published. Errors will be promptly corrected when discovered.

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* The 5th Annual Symposium of the Network for the Advancement of Transfusion Alternatives (NATA) held in Athens, Greece addressed the need for enhancing blood conservation in surgery through the use of cell salvage equipment, improving blood procurement and usage, and the use of non-plasma-based volume expander solutions. Below are brief summaries of selected presentations:

• A multicenter Italian “Multicomponent Collections” (MCC) trial utilizing the HAEMONETICS MCS Plus and GAMBRO BCT’S Trima automated apheresis systems documented respective cost savings for FFP and apheresis platelet collection of 38% and 17% versus collection of these products by conventional single-component apheresis. However, the cost of collecting two red blood cell units by MCC was comparable to the cost of the traditional whole blood collection method. The investigators concluded that MCC allows a blood center to tailor its blood component collections to its specific needs, thereby increasing productivity.

• Certain defined platelet dysfunction and thrombocytopenic disorders can be managed using DDAVP or Factor VIIa in lieu of platelet transfusions, accord-ing to several studies reviewed in a presentation titled “Alternatives to Platelet Transfusions.” No platelet substitute developed to date appears to provide all of the major functions of platelets.

PLASMA FRACTIONATION NOTES

* Applying its 12 years of cumulative expertise in large-scale chromatographic purification of Fraction IV paste, KAMADA has developed a liquid, ready-to-use alpha-1 proteinase inhibitor concentrate. The product is double virus inactivated, formulated as a 2% solution, and packaged in a 50 mL vial size. The Israeli-based firm has submitted applications for regulatory approval in a number of countries, for use as chronic replacement therapy in persons with congenital alpha-1 proteinase inhibitor deficiency and demonstrable panacinar emphysema.

According to a company official, Kamada’s alpha-1 proteinase inhibitor production capacity now ranks among the world’s largest.

Advertising Rates: 1/4 page horizontal (3” x 9”) $200 each issue; 1/3 page horizontal (4” x 9”) $300 each issue; 1/2 page horizontal (5” x 8”) $400 each issue. Insert – provided by the client -- $400 per issue.

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PRODUCT SAFETY UPDATE

* PATHOGEN REMOVAL AND DIAGNOSTIC TECHNOLOGY, a joint venture of ProMetic Life Sciences and the AMERICAN RED CROSS, has reportedly demonstrated that its “Prion Reduction Device” is able to achieve “a significant decrease” in infectious prions responsible for transmissible spongiform encepha-lopathy (TSE) in spiked red blood cell concentrates. This device incorporates ProMetic’s proprietary “Mimetic Ligands” technology to remove prions from blood or other biopharmaceutical products. ProMetic also suggests that this product, which is targeted for on-site filtration of donor blood at collection centers, may also reduce the possible transmission of uniformly fatal variant Creutzfeldt-Jakob disease.

This study, conducted at the University of Maryland-affiliated VA Medical Research Service, confirmed that PRDT’s device removes the infectious prion protein to the limit of detection by in vitro models, according to the PRDT project director. A senior Red Cross official hailed the result as “great news for the blood industry.”

PEOPLE

* The newly created CSL subsidiary ZLB BEHRING has identified its executive man-agement team:

Peter Turner PresidentPaul Walton Senior Vice President, IntegrationJohn Bennett Senior Vice President, Business DevelopmentGregory Boss Senior Vice President, General CounselDennis Jackman Senior Vice President, External AffairsJudith Mamora Senior Vice President, CFOKathy Munro Senior Vice President, PlanningJames Engle Senior Vice President, CIOKelvin Milroy Senior Vice President, Human ResourcesMary Sontrop Senior Vice President, Marburg/ViennaTimothy Moore Senior Vice President, KankakeeUwe Jocham Senior Vice President, BerneDaniel Albrecht Senior Vice President, QualityGordon Naylor Senior Vice President, Plasma ServicesJeff Davies Senior Vice President, Research and DevelopmentAlberto Martinez, MD Executive Vice President, Commercial Operations

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* The LABORATOIRE FRANÇAIS DU FRACTIONNEMENT ET DES BIOTECH-NOLOGIES (LFB) has appointed Pierre François Falcou, MD as senior director, international, in charge of export sales and other international commercial activities, including custom fractionation and corporate alliances. Over the past seven years, Dr. Falcou has held several positions in sales, marketing and business development at LFB.

* The AMERICAN RED CROSS has named John “Jack” McGuire to succeed Ramesh Thadani as its executive vice president for Biomedical Services; Mr. Thadani left Red Cross last August. Mr. McGuire will report directly to Red Cross president and CEO Marsha Evans. “Mr. McGuire will lead the Red Cross in fulfilling our commitment to provide a safe and available blood supply,” according to a news release. Mr. Mc-Guire most recently served as president of Whatman PLC, North America; Whatman is a UK-based manufacturer of filtration and separation materials and devices for the laboratory and industrial markets. Between 1997 and 2001, he was president and CEO of Hemasure, which was subsequently acquired by Whatman. In 2000, Mr. McGuire received the AABB’s Distinguished Service Award, recognizing his commitment to AABB and its work to improve patient access to new blood banking technologies.

* NORTHFIELD LABORATORIES has announced that Eva Essig, PhD will join the development-stage blood substitutes company as vice president of regulatory affairs. Dr. Essig previously served as director, worldwide regulatory affairs at Searle/Phar-macia, now part of Pfizer.

NEW PRODUCTS

* AABB PRESS (Bethesda, MD) has published a new, “state-of-the-art” reference titled Bacterial and Parasitic Contamination of Blood Components. As medical advances in the late 20th century have virtually eliminated known viral risks from blood and blood components, this publication focuses on the residual transfusion-transmitted disease risk attributable to certain bacteria and parasites. Chapters from recognized leaders in their fields cover major blood-borne bacterial species, as well as parasites responsible for syphilis, malaria, Chagas’ disease and other parasitic infections. Spe-cific topics include:

• History, pathology and epidemiology of these infections;• Detection strategies and the potential for pathogen reduction;• Avoidance of infection; and• Implementation and cost-effectiveness strategies

To order online, go to www . aabb.org > marketplace.

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RECENT U. S. PATENTS

* Nucleic Acids and Protein Variants of hG-CSF with Granulopoietic Activity. #6,627,186. Assigned to Xencor (Monrovia, CA). A non-naturally occurring GPA protein comprising at least five amino acid substitutions as compared to hG-CSF pro-tein.

* Erythropoietin Solution Preparation. #6,627,187. Assigned to Chugai Seiyaku Kabushiki Kaisha (Tokyo, Japan). An EPO solution preparation containing EPO in combination with 5-10 mg/mL L-histidine as a stabilizer.

* Methods and Compositions for Control of Blood Coagulation. #6,627,193. As-signed to University of Georgia Research Foundation, Inc. (Athens, GA). A method for producing activated protein C in a medium comprising protein C, involving contacting the medium with an effective amount of an arginine-specific cysteine proteinase of bacterial origin.

* Activated Immunoglobulin. #6,627,194. Assigned to Nippon Zoki Pharmaceuti-cal Co., Ltd. (Osaka, Japan). Activated immunoglobulin prepared by subjecting im-munoglobulin to an activating operation by admixing it with a histamine component followed by removal of histamine from the mixture.

* Solutions for Use as Plasma Expanders and Substitutes. #6,627,393. Assigned to BioTime, Inc. (Berkeley, CA). A method for increasing the circulating volume of a hypovolemic subject comprising administering a plasma-like substance comprising a terminally sterilized aqueous solution of at least one hydroxyethyl starch selected from either a low- or high-molecular form.

* Thrombin Derived Polypeptides; Compositions and Methods for Use. #6,627,731. Assigned to Pharmacia Corporation (St. Louis, MO) and the University of Texas System (Austin, TX). A method of inhibiting tumor cell growth in a patient in need of such treatment, by administering a peptide comprising the tetramer Arg-Gly-Asp-Ala, wherein the peptide is a subsequence of thrombin and wherein the peptide lacks a serine esterase conserved domain.

* Factor IX Purification Methods. #6,627,737. Assigned to Genetics Institute, LLC (Cambridge, MA). A method for separating active recombinant Factor IX (rFIX) from a composition comprising inactive rFIX, comprising the steps of (1) applying the composition to an hydroxyapatite resin, (2) washing the hydroxyapatite resin with a first buffer whose salt concentration is sufficient to remove the inactive rFIX, and (3) eluting the hydroxyapatite resin with a second buffer, whose salt concentration is sufficiently high to elute the active rFIX.

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* NO-Modified Hemoglobins and Uses Therefor. #6,627,738. Assigned to Duke University Durham, NC). A method of inhibiting vasoconstriction, involving admin-istering a composition comprising nitrosylhemoglobin for a time and under conditions to inhibit vasoconstriction.

* Activated Protein C Formulations. #6,630,137. Assigned to Eli Lilly and Company (Indianapolis, IN). A lyophilized formulation having less than about 10% des(1-9) and des(1-10) activated protein C by combined weight.

* Protein C Derivatives. #6,630,138. Assigned to Eli Lilly and Company (Indianapo-lis, IN). A human protein C derivative comprising an amino acid sequence defined in the patent.

* Thrombin Derived Polypeptides: Compositions and Methods for Use. #6,630,572. Assigned to The Board of Regents, University of Texas Systems (Austin, TX) and Pharmacia Corporation (St. Louis, MO). A method for promoting wound heal-ing comprising applying to a wound a therapeutically effective amount of a purified thrombin peptide, consistently essentially of a thrombin receptor binding domain and s serine esterase conserved sequence, and wherein this peptide has fewer amino acids than thrombin.

* G-CSF Analog Compositions and Methods. #6,632,426. Assigned to Amgen Inc. (Thousand Oaks, CA). A G-CSF molecule with certain modifications described in the patent.

* Directed Human Immune Globulin for the Prevention and Treatment of Staphy-lococcal Infections. #6,632,432. Assigned to Henry M. Jackson Foundation for the Advancement of Military Medicine (Rockville, MD). A method of preparing a Directed Human Immune Globulin having opsonophagocytic bactericidal activity against Staphylococcus epidermidis for the prevention or treatment of S. epidermidis infections. Plasma donors are immunized with an S. epidermidis vaccine, and plasma is removed from these donors for making Directed Human Immune Globulins.

* Methods of Terminal Sterilization of Fibrinogen. #6,632,648. Assigned to Elan Drug Delivery Limited (Nottingham, UK). A method of terminal sterilization of a biologically active product suitable for sterile administration.

* Normothermic, Hypothermic and Cryopreservation Maintenance and Storage of Cells, Tissues and Organs in Gel-Based Media. #6,632,666. Assigned to Bio-Life Solutions, Inc. (Candor, NY). A method for increasing the storage duration of a cell sample at frozen temperatures, involving the addition of a medium containing a liquid-state gelling agent.

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* Multi-Purpose Reagent System and Method for Enumeration of Red Blood Cells, White Blood Cells and Thrombocytes and Differential Determination of White Blood Cells. #6,632,676. Assigned to Clinical Diagnostic Solutions (Plantation, FL). A multi-purpose isotonic diluent reagent, consisting of an aqueous solution of from about 1.5% to about 1.8% w/v of a single alkali metal sulfate salt selected from a group described in the patent.

* Method for Performing Activated Clotting Time Test with Reduced Sensitivity to the Presence of Aprotinin and for Assessing Aprotinin Sensitivity. #6,632,678. Assigned to Sienco, Inc. (Wheat Ridge, CO). An in vitro diagnostic process for mea-suring blood coagulation, involving adding a reagent for contact activation to a blood sample containing heparin and aprotinin.

* Method to Determine the Speed of Sedimentation of Blood and Other Parameters Correlated Thereto, and Relative Apparatus. #6,632,679. Assigned to Sire Ana-lytical Systems Srl (Udine, Italy). A method to determine a speed of sedimentation, viscosity, elasticity and density of blood.

* One-Step Immunoassay for the Determination of Antigen-Specific Antibodies of One of the Immunoglobulin Classes A, M, D, or E, and an Agent Suitable for this Purpose. #6,632,682. Assigned to Dade Behring Marburg GmbH (Marburg, Germany). An immunological method for the detection of an antigen specific antibody comprising one or more of the immunoglobulin classes A, M, D or E in a fluid.

* Particles of HCV Envelope Proteins: Use for Vaccination. #6,635,257. Assigned to Innogenetics N.V. (Ghent, Belgium). An oligomeric particle with a diameter of 1 to 100 nm and consisting of HCV envelope proteins, or parts thereof, with at least one alkylated cysteine amino acid moiety.

* Methods and Compositions for Increasing Protein Yield from a Cell Culture. #6,635,448. Assigned to Clonex Development, Inc. (Chicago, IL). A method of increasing yield of a protein from a cell culture, involving transfecting a cell of the cell culture with a first and a second expression vector defined in the patent.

* Polypeptides and Polynucleotides from Coagulase-Negative Staphylococci. #6,635,473. Assigned to The Provost Fellows and Scholars of the College of the Holy and Undivided Trinity of Queen Elizabeth Near Dublin (Dublin, Ireland); and The Texas A & M University System (College Station, TX). An isolated nucleic acid molecule encoding a fibrinogen-binding protein, wherein the fibrinogen-bind-ing protein is isolated from coagulase-negative Staphylococcus epidermidis, and wherein the nucleic acid encodes SdrG.

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MEETINGS

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June 3–8, 20042004 American Society of Clinical OncologyNew Orleans, LATel: 703-299-0150Fax: 703-299-1044E-mail: asco@asco.orgWeb: www.asco.org

June 9–11, 2004PPTA Plasma ForumGrand HyattWashington, DCTel: 410-263-8296Fax: 410-263-2298Web: www.pptaglobal.org

June 10-13, 20049th Congress of the European Hematology AssociationGeneva, SwitzerlandTel: +31 20 679 34 11Fax: +31 20 673 73 06Email: eha2004@eurocongress.com

July 11–15, 2004International Society of Blood Transfusion Edinburgh International Conference CentreEdinburgh, Scotland, UKTel: +44 131 556 9245Fax: + 44 131 556 9638 E-mail: ISBT@in-conference.org.ukWeb: www.ISBT2004.com

July 22-23, 2004Blood Products Advisory CommitteeHoliday InnGaithersburg, MDTel: 301-827-3514Web: www.fda.gov

October 23-26, 2004AABB Annual Meeting & TXPOBaltimore Convention CenterBaltimore, MDTel: 800-375-2586Tel: +1-617-621-1398Email: www.aabb@.org