VOLUME 24 ISSUE 12 JULY 2007 - Marketing Research Bureau · international blood/plasma news JULY 2007 Page 168 * NABI BIOPHARMACEUTICALS and KEDRION S.p.A. have signed a European

Notice: International Blood/Plasma News© is Protected by Copyright Law. Reproduction or Photocopy of Any Part Without The Publisher‘s Permission is Prohibited by Law.

ISSN 0742-7719

EDITOR: KEITH BERMAN PUBLISHER: PATRICK ROBERT

Published by: The Marketing Research Bureau, Inc. 284 Racebrook Rd. Orange, CT 06477

VOLUME 24 ISSUE 12 JULY 2007

BUSINESS BRIEFS 166

BLOOD & BIOTECHNOLOGY 171

RESEARCH & DEVELOPMENT 172

PLASMA FRACTIONATION NOTES 174

PRODUCT SAFETY UPDATE 175

PEOPLE 176

NEW PRODUCTS 176 RECENT U.S. PATENTS 177

MEETINGS / SUBSCRIPTION FORM 180

____________________COMPANIES IN THIS ISSUE__________________ABBOTT LABORATORIESAMERICAN RED CROSSAVENTIS BEHRINGBAXTER HEALTHCAREBAXTER HEALTHCARE S.A.BEIJING TIANTAN BIOLOGICALBIOLEX THERAPEUTICSCryoLifeCSL BEHRINGELI LILLYGENETICS INSTITUTEHAEMONETICSHARDISHemaCareHEMOBRASHEMODYNEHuman BioSystemsINFONALEKAMADAKEDRION

KING PHARMACEUTICALSJAPANESE RED CROSSLFBMedImmune VaccinesNABI BIOPHARMACEUTICALSNEKTAR THERAPEUTICSNEUROSPHERES HOLDINGSNIR DIAGNOSTICSNORTHFIELD LABORATORIESOMRIX BiopharmaceuticalsORTHO-CLINICAL DIAGNOSTICSPPTAProMetic Life SciencesProtalix BioTherapeuticsSANQUIN BLOOD FOUNDATIONS-CELL BIOSCIENCESTALECRIS BIOTHERAPEUTICSWYETH PHARMACEUTICALSZLB BEHRING GmbHZymoGenetics

international blood/plasma news

JULY 2007

Page 166

BUSINESS BRIEFS

* The U.S. FDA has granted marketing approval for CSL BEHRING’S Privigen 10% liquid intravenous human immunoglobulin product. Purifi ed by a chromatography-based method originally developed at CSL, Privigen is “the fi rst and only proline-stabilized IVIg preparation that is “always ready for immediate use,” requiring no refrigeration or reconstitution, according to the company. The product is indicated for patients with primary immunodefi ciency (PI) disorders and patients with chronic idiopathic thrombocytopenic purpura (ITP) who require rapid elevation in platelet counts to prevent bleeding.

In an open-label prospective study of 80 U.S. and European PI patients receiving Privigen at doses ranging from 200 mg/kg to 888 mg/kg every three or four weeks, the annual rate of serious bacterial infections was 0.08 infections per subject per year. The annual rate of any infections was 3.55 infections per subject per year. A European open-label prospec-tive trial involved infusions of 1 g/kg of Privigen on consecutive days in 57 chronic ITP patients with baseline platelet counts ≤20 x 109/L. Forty-six of these patients (80.7%) experienced an increase in platelet counts to ≥50 x 109/L.

* To satisfy the preference of certain physicians, patients and pharmacists for a lyophilized IVIg formulation, a senior CSL BEHRING offi cial said the company will continue to manufacture and supply Carimune NF, Redimune and Sandoglobulin NF products along with the new Privigen IVIg product. CSL Behring expects that these older ly-ophilized products, as well as a Sandoglobulin Liquid IVIg preparation currently available in some European countries, will be gradually phased out of its global markets, and will disappear entirely after a few years.

* The U.S. FDA has approved a new 3000 IU dosage strength of BAXTER HEALTH-CARE’S ADVATE recombinant plasma/albumin-free factor VIII concentrate. Like the 250 IU, 500 IU, 1000 IU, 1500 IU and 2000 IU product strengths, the 3000 IU strength is reconstituted with 5 ml of sterile water, which is supplied together with the BAXJECT II needleless transfer device. The 3000 IU strength “makes it easier and faster for people requiring higher doses…by decreasing the number of vials needed and reducing their total infusion volume,” according to a company news release.

ADVATE is currently approved for use in the U.S., Canada, Australia, Japan and Europe. Baxter anticipates full European marketing approval of the 3000 IU product strength in 2008.


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* The Japanese Red Cross Society is consolidating 50 blood centers nationwide, into about 20 production facilities. The main reason for the integration was fi nancial losses it incurred while trying to shore up its HIV examination system. However, hospitals are concerned that the consolidation plan could bring about a shortage of blood supplies if and when large amounts are needed for transfusions. The society will stop production of blood products at the remaining 30 centers and turn them into facilities for collecting, storing and distribution of the products manufactured by the other 20 centers. The 23 centers for screening HIV in donated blood had already been integrated in April of this year, and the number of such centers nationwide will be integrated into 10 by next summer.

* Chinese State Food and Drug Administration authorities are investigating the illegal distribution of thousands of bottles of counterfeit human albumin to hospitals in the Chinese provinces of Jilin, Shanxi, Qinghai, Hubei, Shandong, Liaonning, Chongqing and Xinjiang. Of 2,042 bottles of fake albumin tracked down by authorities in Jilin, 1,554 had already been infused by 18 local hospitals and had passed through 39 drug distribu-tors. Altogether, about 60 hospitals in northeastern China have reportedly purchased and used the fake material. The counterfeit bottles were packaged and labeled to appear to be made by legitimate manufacturers, including BEIJING TIANTAN BIOLOGICAL PRODUCTS and certain international suppliers. Introduction of counterfeit albumin into the supply chain has occurred amid a national albumin shortage.

An analysis of samples determined that they contained no albumin; polysorbate-80, a yellowish liquid that appears similar to albumin, was found to make up most of the fake product. Infusion of polysorbate-80 can be serious or life-threatening for severely ill patients who require intravenous albumin therapy. Polysorbate-80 can also cause se-vere adverse effects or death in patients who are allergic to it. An offi cial estimated that the fake product cost roughly 10 yuan ($1.30) to make, and was being sold at albumin market rates of about 300 yuan ($39.25). In a published statement, drug offi cials say that an investigation of fake albumin reports that began in March has effectively cleaned up the market. The government has not disclosed whether anyone has died or become ill as a result of being infused with the bogus product instead of the albumin prescribed for them.

* Meanwhile, Hong Kong police have seized at least 4,000 units of blood products, in-cluding intravenous immunoglobulin and albumin, bearing fake labels with bogus or no registration number, according to a report by Bloomberg News. Counterfeit products valued at about HK$1.5 million ($192,000) were allegedly found in the inventories of one licensed Hong Kong-based drug wholesaler, according to the South China Morning Post. Department of Health offi cials disclosed that the fake drugs bore labeling of seven pharmaceutical brands. To date, they have not received reports of adverse effects related to counterfeit products infused into patients.


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* NABI BIOPHARMACEUTICALS and KEDRION S.p.A. have signed a European and U.S. development and commercialization deal for Nabi’s Civacir hepatitis C immune globulin product, which they hope will become the fi rst therapy for the pre-vention of recurrence of hepatitis C-related liver disease in HCV-positive liver transplant recipients, or in patients who receive an HCV-positive liver. Kedrion has agreed to as-sume development costs for this product candidate both in Europe and the U.S. through at least Phase II clinical trials.

The two companies will jointly oversee the development and registration of Civacir in Europe and will work collaboratively on the design and implementation of a U.S.-Euro-pean Phase II trial planned to start in the second half of this year. With positive results from the Phase II trial, the two companies would then collaborate on the development of a pivotal Phase III trial of Civacir. Nabi offi cials characterized this agreement as “a validation of the clinical and commercial potential of the Civacir program” and “a major funding event for Nabi.”

* HAEMONETICS has acquired INFONALE, a Pennsylvania-based develop of software for optimizing hospital blood use and management, for $1.3 million plus a contingent consideration based on future operating performance. This acquisition supports Haemonetics’ vision to bring its blood collection and hospital customers a suite of blood management solutions that can reduce costs and improve outcomes, according to a company statement.

* The European Hemophilia Consortium has a new website www . ehc.eu that provides information and data related to hemophilia patients and their care throughout Europe. For example, the percentage of patients with hemophilia infected with HIV or hepatitis C virus is reported as follows for selected European countries:

HIV HCV

Austria 12.0% 22.7%

Cyprus 1.9% 12.6%

Denmark 6.8% 53.8%

Greece 9.3% 44.4%

Hungary 0.9% 27.5%

Ireland 6.8% 28.8%

Slovenia 9.1% 31.7%

Spain 26.8% 58.5%

United Kingdom 6.6% 46.3%


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* The U.S. FDA has approved a new intranasal spray delivery device for KING PHAR-MACEUTICALS’ bovine thrombin topical hemostatic product, to aid in stopping epistaxes, or nosebleeds. The THROMBIN-JMI Epistaxis Kit offers emergency depart-ment and trauma center staff “a convenient new option to achieve fast, active hemostasis during epistaxes,” a company offi cial said. Currently, nosebleeds are controlled by plug-ging the nostrils with gauze and other packing agents. However, these methods are often uncomfortable and can impose certain health risks. The THROMBIN-JMI Epistaxis Kit will be promoted as a convenient, easy-to-use alternative to achieve rapid control of active bleeding.

When it is launched in the fourth quarter of this year, this product will join King’s THROMBI-Pad, a composite of lyophilized THROMBIN-JMI and a three-square-inch gauze pad designed to achieve active hemostasis at bleeding sites where trauma dressings would otherwise be used.

* OMRIX Biopharmaceuticals has received U.S. FDA approval to use cryoprecipitate purchased from TALECRIS BIOTHERAPEUTICS as raw material to manufac-ture “biological active component” (BAC), the fi brinogen-containing component of its marketed fi brin sealants, Evicel and Quixil, and its investigational fi brin patch product. “Utilizing cryo in our manufacturing process will allow OMRIX to lessen its dependence on plasma and in the long-run, realize better gross margins,” a company of-fi cial said.

This new approval to use Talecris’ cryoprecipitate as its key raw material will enable OMRIX to ship “substantial quantities” of Evicel to ETHICON, its U.S. and European marketing partner. Heretofore, the company’s capacity to manufacture fi brin sealants was constrained by a limited plasma fractionation capacity at its Israeli-based production plant. OMRIX announced its long-term cryoprecipitate supply agreement with Talecris in October 2006. That arrangement commits OMRIX to certain minimum purchases along with a right of fi rst refusal to additional quantities of cryoprecipitate.

* The Jordanian Ministry of Health has disclosed the results of its most recent tender for plasma products, which was awarded in its entirety to the UK fractionator BPL:

• Factor VIII: 3,000 vials of 250 IUs/vial and 3,000 vials of 500 IUs/vial, or a total of 2.25 million IUs. The price was $0.218 per IU.

• Human albumin: 17,000 vials (20%, 50 mL) or 170 kg. The price was $24.00 per vial ($2.40 per gram).

• IVIG: 8,600 2.5 gram vials or 21.5 kg. The price was $60.00 per gram. Other bidders reportedly offered IVIG at $78 and $91 per gram.

• Rh immune globulin: 6,000 vials, offered for $48.00 per vial.


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* Below are recent highlights from the 2006 annual report of the SANQUIN BLOOD FOUNDATION:

• 578,145 whole blood donations and 272,909 plasmaphereses were collected in 2006, and all components were leukocyte-reduced by fi ltration;

• 940 liters of anti-D plasma were collected;

• Demand for whole blood and red blood cells decreased by 2.4% from 2005, while the production of platelets, both from whole blood and cytapheresis) increased by 8.4%. Demand for fresh frozen plasma (which is all quarantined) decreased by 1.6% in 2006; and

• About 308,000 liters of recovered plasma were collected in 2006, 3.1% less than in 2005.

According to Sanquin, “the demand for plasma is determined both by the request for immunoglobulins and the needs for plasma-derived factor VIII.” Among its research initiatives, Sanquin initiated a multicenter study on Transfusion Related Acute Lung In-jury (TRALI) to confi rm the clinical usefulness of plasma from donors who have had no alloimmunization history (pregnancy, blood transfusion or tissue transplant). A “Transfu-sion Register for Irregular Antibodies and X-Test Problems” was also implemented in a number of hospitals, with the goal of reducing or delaying transfusion reactions.

* Below are highlights of HAEMONETICS’ fi scal 2007 annual report:

• Worldwide plasma disposable (for PCS machines) revenues were $126.9 million, increasing 16.4% from the previous year. U.S. plasma disposable revenues amounted to $72 million, a 30.4% increase in 12 months.

• Red cell disposable (for MCS and Cymbal collection systems) revenues were $43.4 mil-lion worldwide (+14.7%), including U.S. revenues of $36 million (+18.6%). A newly negotiated multi-year agreement was signed with the AMERICAN RED CROSS.

• Worldwide revenues generated by the CellSaver and SmartSuction products were $66.6 million, the OrthoPAT autotransfusion system contributing $30.5 million (+39.6%).

• Worldwide software and services sales Services (Donor Management Systems, Logic Track, eQUE Automated Interview & Assessment systems, etc) totaled $33.7 million, increasing by 25 percent over the prior year.

• Blood bank disposable sales (for MCS machines) amounted to $126.2 million (-4.7%).

• Finally, equipment sales amounted to $22.2 million (-13.7%), for a grand total of $449.6 million.


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* CryoLife reports that second quarter sales of its bovine albumin-based biological adhesive, BioGlue, increased 5.5% compared to the same period a year ago to $10.9 million, and now accounts for nearly 50% of the company’s revenues. Revenues from CryoLife’s tissue preservation services, which comprise mainly cardiac valves and vascular grafts, rose 15% to $11.7 million.

BLOOD & BIOTECHNOLOGY

* Protalix BioTherapeutics, an Israeli development-stage company, has announced that it has reached an agreement with the U.S. FDA on the fi nal design of a pivotal Phase III clinical trial of “prGCD,” the company’s proprietary plant cell-expressed recombinant form of human glucocerebrosidase. This agreement was reached under the FDA’s Special Protocol Assessment (SPA) process. This investigational product is intended for the treatment of Gaucher disease, a genetic lysosomal storage disorder, which is caused by a defect in the enzyme glucocerebrosidase.

Beginning in the third quarter of 2007, the company expects to start enrolling Gaucher patients at leading academic centers in the U.S., Israel and other countries around the world. Protalix believes its plant cell-based recombinant protein expression system is safe and scalable, and will allow for the cost-effective, industrial-scale production of human glucocerebrosidase and other therapeutic proteins.

* The U.S. military’s Defense Advanced Research Projects Agency (DARPA) has is-sued a solicitation for research proposals to develop a technology to achieve in vitro production of red blood cells that are readily available and free of storage lesions. The objective, according to DARPA, is to replace the system of using donor blood for transfusions with what it has dubbed “blood pharming,” which would consist of a self-renewing starter population of red blood cells and a means of harvesting and packaging transfusable cells.

The DARPA solicitation document acknowledges that there are technological gaps that must be bridged before “blood pharming” could replace transfusions. While scientists have been able to produce red cells using progenitor samples taken from bone marrow, umbilical cords or blood, no one has been able to to create new cells on a large scale. Contract applicants that advance past the proposal stage will participate in “an ex-tremely aggressive, milestone-driven program,” that will require them to show that their system can produce at least 10 units of Type O negative red blood cells per week for four weeks. The next hurdle will be to produce 100 units per week for eight weeks, followed by a fi nal development stage requiring a production system capable of operating in a war zone and able to withstand extreme temperatures, humidity, dust and frequent transport.


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* BIOLEX THERAPEUTICS researchers have presented results demonstrating that a full-length recombinant plasmin produced with the company’s proprietary LEX System is indistinguishable from human plasma-derived plasmin in characterization and activity. The LEX System is the fi rst recombinant protein expression system reported to produce commercially viable levels of full-length thrombin, according to the company. Plasmin has been proposed as a potential thrombolytic agent for several decades, but pro-duction challenges have frustrated attempts at commercial-scale development. Clinical studies of Biolex‘ recombinant plasmin, dubbed “BLX-155,” are planned to begin in the fi rst half of 2008. These fi ndings were presented at this month’s XXIst Congress of the International Society on Thrombosis and Haemostasis in Geneva.

RESEARCH AND DEVELOPMENT

* Selective removal of fi brinogen from blood using fi brinogen apheresis appears to improve symptoms of peripheral artery disease, according to Italian researchers at the 76th congress of the European Atherosclerosis Society. Total walking distance increased from 79 ± 60 to 194 ± 80 meters (p = 0.006) and pain-free walking distance improved similarly in seven male patients affected by PAD, after two apheresis sessions at weekly intervals.

* CSL BEHRING has completed patient enrollment in a Phase III clinical trial of a new 20% praline-stabilized formulation of its subcutaneous immunoglobulin (Ig-Pro20) product to treat patients with primary immunodefi ciency (PI) disorders who require immune globulin replacement therapy. This open-label study involving 13 U.S. treatment sites is assessing the effi cacy, tolerability, safety and pharmacokinetics of SCIg stabilized with praline in subjects with PI. Serious bacterial infection rates in male and female subjects ranging in age from 2 to 75 years will be evaluated. The trial will also aim to document non-inferiority in steady-state ar3ea under the curve of immunoglobulin G (IgG) levels of weekly subcutaneous infusions of IgPro20 compared to the prior three to four weekly treatments with intravenous immunoglobulins.

In January 2006, CSL Behring introduced Vivaglobin, the fi rst human subcutaneous im-munoglobulin replacement therapy licensed in the U.S. for patients with primary immu-nodefi ciency disorders.

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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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* Transfusion of packed allogeneic red blood cells is independently associated with the development of acute respiratory distress syndrome (ARDS) in ICU patients, ac-cording to a cohort study of 4,892 critically ill patients enrolled in 284 centers throughout the U.S. The unadjusted odds ratio of developing ARDS in transfused patients was 2.74, compared to those never transfused. After adjusting for age, baseline severity of illness, admitting diagnosis and process-of-care factors, the independent relationship between pRBC transfusions and ICU-onset ARDS remained signifi cant with an odds ratio of 2.80 (95% CI, 1.90 to 4.12; p<0.0001).

A baseline serum albumin level of ≤ 2.3 g/dl was also found to be importantly associated with risk of ARDS, with an odds ratio of 2.737. Of 4,484 patients without ARDS, 29.8% had a baseline albumin level of ≤ 2.3 g/dl, while 54.0% of patients with ARDS had this very low baseline albumin level. This pattern persisted after multivariate analysis, with an odds ratio of 1.93 for developing ARDS when the baseline albumin level was ≤ 2.3 g/dl. This report was published in the July issue of Critical Care.

* Preliminary data from a Phase Ib/II trial suggest that an orally active drug developed by ProMetic Life Sciences may increase hemoglobin levels in patients with chemo-therapy-induced anemia (CIA). Two-thirds of patients treated with “PBI-1402” experi-enced an average 1.4 g/dL increase in their hemoglobin levels, while one-third maintained their hemoglobin levels. No patients treated with “PBI-1402” as monotherapy required a blood transfusion. Neutrophil levels increased in all patients with low neutropenia, while patients with normal-range neutrophil counts experienced no change. “PBI-1402” was well tolerated by all patients, with no serious reported side effects.

ProMetic has concluded that “PBI-1402” is “a good candidate for further clinical de-velopment” for CIA and anemia related to cancer. The company notes that there is “a signifi cant rate (e.g. 40-50 percent) of non-response to recombinant erythropoietin” in patients with CIA. Combination therapy with low-dose erythropoietin and “PBI-1402” is also possible, as preclinical data suggested that the two drugs have an additive effect and stimulate erythropoiesis through different mechanisms of action.

* WYETH PHARMACEUTICALS announced that it has assumed all marketing and distribution rights to BeneFIX recombinant coagulation factor IX in Europe. This transfer of responsibility follows the conclusion last month of a 10-year distribution rights agreement between BAXTER HEALTHCARE and GENETICS INSTITUTE. Wyeth acquired Genetics Institute in 1996. Wyeth now manufactures and markets recombinant factor VIII and factor IX products for treatment of hemophilia A and B, respectively, in Europe.


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* Following discussions with the European Agency for the Evaluation of Medicinal Products (EMEA), KAMADA is planning a phase II clinical trial of an inhaled ver-sion of its alpha-1 antitrypsin (AAT) product to treat cystic fi brosis. A Phase I trial is currently in progress and reportedly shows good intermediate results. Kamada recently received EMEA approval for its plans to conduct Phase II and III clinical trials of AAT for treating congenital emphysema. The aerosolized formulation has been designated an Orphan Drug for the treatment of both cystic fi brosis and congenital emphysema, both in Europe and in the U.S.

* CSL BEHRING’S Beriplex P/N prothrombin complex concentrate (PCC) is highly effective and safe in the emergency reversal of anticoagulation (ACR), according to a multinational 25-center study presented at the XXI Congress of the International Society on Thrombosis and Haemostasis. This prospective , open, uncontrolled study enrolled 43 patients, including 34 patients age >65 years, who required ACR reversal due to either emergency intervention or acute bleeds. Almost all patients had multiple risk factors for developing a thromboembolic event.

Applying a primary endpoint objective of 30-minute post-infusion International Normal-ized Ratio (INR) ≤ 1.3, 42 of 43 patients (98%) were assessed as having “very good” or “satisfactory” response to therapy. This rapid reversal of anticoagulation provided acceler-ated and effective control of hemorrhage, according to the investigators. All administra-tions were well tolerated; of six reported serious adverse events, fi ve were confi rmed to be unrelated to Beriplex P/N and one event was reported to be possibly related.

PLASMA FRACTIONATION NOTES

* The Laboratoire Français du Fractionnement et des Biotechnologies (LFB) has just been awarded a new toll fractionation contract by the Brazilian Ministry of Health. The agreement calls for an annual volume of approximately 150,000 liters of recovered plasma to be processed into albumin, IVIG, factor VIII and factor IX at the LFB’s two fractionation plants (Les Ulis and Lille). Plasma will be collected from 102 blood centers throughout Brazil. This $25 million contract can be renewed for a new fi ve-year period. In 2002, the LFB was awarded a portion of the Brazilian fractionation contract, which ended in 2004. Along with Brazil, the LFB fractionates plasma on contract for Luxembourg, Morocco and Tunisia and processes bulk fractions for Belgium.

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Published by: The Marketing Research Bureau, Inc. 284 Racebrook Road, Orange, Connecticut 06477 Phone: (203) 799-0298 Fax: (203) 891-8855 e-mail: [email protected] http://www.marketingresearchbureau.com


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* Meanwhile, HEMOBRAS, a paragovernmantal organization created by the Brazilian Ministry of Health to establish a domestic plasma fractionation facility, is currently in discussions with three European fractionators regarding a potential technology transfer arrangement. The new plant will reportedly be located in Recife, in the state of Pernambuco, at some distance from an existing fractionation plant operated by HE-MOPE.

* Through a public-private collaboration with various Italian academic centers, KE-DRION GROUP subsidiary HARDIS S.p.A. is now developing the fi rst European hyperimmune globulin product specifi cally targeting hepatitis C viral antigens. The €12 million cost of the project is being shared amongst the various participating bodies, notably including the Retrovirus Centre in Pisa University and the National Research Council in Milan. It will run for 36 months, and the program’s operational continuity will be guaranteed for a further fi ve years after conclusion of the project.

A commercial anti-hepatitis C immunoglobulin product “should guarantee a better qual-ity of life and a reduced risk of re-contracting the [hepatitis C] virus in liver transplant patients, patients on dialysis and people who have received a kidney transplant,” accord-ing to a Kedrion press release. The company estimates that the “western” market for this hyperimmune globulin is $400 million, with $200 million in the U.S. and $40 million in Italy.

PRODUCT SAFETY UPDATE

* The WORLD HEALTH ORGANIZATION (WHO) has launched a new initiative to eliminate Chagas disease by 2010. Noting that “cases identifi ed in non-endemic countries have demonstrated the need to globalize our efforts,” the WHO’s strategy will focus on fi nding an effective test for screening and diagnosis, setting up systems to prevent Chagas transmission through blood transfusions and organ transplantation, and strengthening epidemiological systems.

According to WHO estimates, fewer than eight million people in Latin America remain infected with the parasite, Trypanosome cruzi, that causes Chagas disease. A WHO con-sultant reports “good progress” in halting the transmission of Chagas disease from insects to humans in Brazil, Chile and Uruguay, and “partial success” in Argentina, Honduras and Paraguay.


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PEOPLE

* NABI BIOPHARMACEUTICALS has appointed Matthew W. Kalnik, PhD as vice president, business development and project management. Dr. Kalnik most recently served as executive vice president of business development at VistaGen Therapeutics. He earlier held senior management positions at Genaissance Pharmaceuticals, Pharmacia, Pfi zer and Daiichi Medical Research.

* The AMERICAN RED CROSS has named William F. “Bill” Moore as its new senior vice president of operations, Biomedical Services, replacing Jack McGuire. Prior to joining the organization in September 2005, Mr. Moore held leadership positions in manu-facturing, supply chain, engineering, R & D and quality over a period of 20 years with American Cyanamid and Cytec Industries. He holds an MBA and a bachelor’s degree in chemical engineering.

* HemaCare president and CEO Judi Irving submitted her resignation late last month to pursue other opportunities, according to a company statement. Chairman Julian Steffen-hagen will step in to serve as interim CEO until a replacement is named. Before joining HemaCare, Ms. Irving worked in senior management positions for HealthNet’s operations in Oregon and Arizona.

* NORTHFIELD LABORATORIES has announced that Eva Essig, PhD, the company’s vice president of regulatory affairs and quality, is leaving to take a regulatory position in the pharmaceutical industry. Richard D. Newman, PhD, DABT, who has served as consultant to the company on regulatory matters since 2003, will “assume a leadership role” in Regulatory Affairs. Dr. Newman has worked on biologics, drugs and medical devices at Proctor and Gamble, G.D. Searle and Baxter Healthcare over the last 25 years. At Baxter, he served in the Renal Division from 1992 through 2002, in regulatory affairs, clinical development and, most recently, R & D roles where he directed global product development.

NEW PRODUCTS

* The U.S. FDA has approved ABBOTT’S PRISM Hepatitis C (HCV) Test for screening donations of blood and plasma for antibodies to HCV. The PRISM instrument con-solidates testing into a single system automating many of the manual testing procedures and steps currently used to screen blood. Licensed and used in more than 30 countries, the PRISM system was approved for use in the U.S. for core hepatitis B virus antigen (PRISM HBcore) in 2005 and two hepatitis B surface antigens (PRISM HBsAg and HBsAg Confi rmatory) in 2006.


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RECENT U. S. PATENTS

* Method to Enhance Hematopoiesis. #7,196,060. Assigned to S-Cell Biosciences, Inc. (Murrieta, CA). A method to stimulate the production of red blood cells in a subject, wherein the subject has been diagnosed as having a less than desirable level of red blood cells. The method comprises administering an amount of T-4 immune stimulating factor (TISF) effective to elevate the red blood cell count.

* Method for the Reduction or Prevention of Post-Surgical Adhesion Formation. #7,198,786. Assigned to Baxter International Inc. (Deerfi eld, IL) and Baxter Health-care S.A. (Vienna, Austria). A method for reducing or preventing adhesions which would form in a human patient during or after surgery, comprising administering to the wound surface a 20-80 mg/ml fi brinogen solution in an amount of about 0.025 ml fi brinogen/cm2 to about 0.25 ml fi brinogen/cm2 of the surface being at risk for developing adhesions.

* Method and Apparatus for Measurement of Blood Substitutes. #7,198,955. Assigned to NIR Diagnostics Inc. Waterloo, Ontario (Canada). A method of determining a cor-rected concentration of an analyte contained in a specimen comprising a blood substitute interferent and a non-blood substitute interferent.

* Polymer-Factor VIII Moiety Conjugates. #7,199,223. Assigned to Nektar Therapeutics Corporation (Huntsville, AL). A conjugate comprising one, two or three water-soluble polymers covalently attached to a Factor VIII moiety, wherein each water-soluble polymer has a nominal average molecular weight in the range of from 6,000 Daltons to 150,000 Daltons and further wherein the conjugate is a 1-mer, 2-mer or 3-mer.

* Capture, Concentration and Quantitation of Abnormal Prion Protein from Biological Fluids Using Depth Filtration. #7,201,901. Assigned to Ortho-Clinical Diagnostics, Inc. (Raritan, NJ). A method of removing prion protein from an aqueous pharmaceuti-cal composition comprising IgG anti-D immunoglobulin, wherein the pharmaceutical composition comprises from about 4.0 to 6.0% immunoglobulin by weight, and from about 80 to 200 ppm polysorbate 80. The composition is admixed with from about 2% to about 10% methanol, and this admixture is fi ltered through a depth fi lter having a pore size providing a retention of less than about 0.6 microns, thereby removing the prion and maintaining recovery of the biological protein in its original biological state at least to a level in excess of about 50%.


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* Compositions, Methods and Apparatuses for Preserving Platelets. #7,202,020. As-signed to Human BioSystems (Palo Alto, CA). A platelet composition suitable for direct transfusion into a patient, which includes (1) a preservation medium comprising plasma, and anti-coagulant and a gel-forming material and (2) platelets which have been stored in a non-frozen state within the preservation medium in a gelatinous state for at least three days at a temperature below 10°C, wherein at least 50% of the platelets are intact and functional based on adenosine diphosphate induced platelet aggregation assay after at least three days.

* Antibodies for Specifi cally Detecting Pathogenic Prions of Human Origin, and Detec-tion Methods Carried Out Using These Antibodies. #7,202,021. Assigned to Aventis Behring GmbH (Marburg, Germany). An isolated antibody, which is formed by one of three hybridoma cell lines specifi ed in the patent.

* Onset of Force Development as a Marker of Thrombin Generation. #7,202,048. As-signed to Hemodyne, Inc. (Bethesda, MD). An assay for identifying a thrombin generation time for a blood sample, comprising (1) positioning a blood sample in an instrument with measures platelet contractile force, and (2) determining onset of platelet contractile force in said blood sample, the onset of platelet contractile force being indicative of a thrombin generation time.

* Stabilized Liquid Preparation of the Protease Which Activates Blood Coagulation Factor VII, or of Its Proenzyme. #7,202,065. Assigned to ZLB Behring GmbH (Mar-burg, Germany). A stabilized liquid preparation between pH 2.0 and 8.0, which comprises a protease or its proenzyme that activates blood coagulation factor VII, and at least one compound selected from a group of moieties defi ned in the patent.

* Methods for Enhancing the Translation and Expression of Recombinant Proteins. #7,202,077. Assigned to ZymoGenetics, Inc. (Seattle, WA). A purifi ed polynucleotide comprising the nucleic acid sequence as shown in SEQ ID NO: 1.

* Use of Hyaluronic Acid Derivatives in the Preparation of Biomaterials with a Physi-cal Haemostatic and Plugging Activity. #7,202,230. Assigned to Fidia Advanced Biopolymers, S.R.L. (Abano Terme, Italy). A method of creating a physical haemostatic barrier to effect haemostasis, comprising applying to a surgical joining of two tissues during anastomotic surgery a biomaterial comprised of at least one hyaluronic acid or a derivative thereof to effect haemostasis by creating a physical haemostatic barrier.


JULY 2007

Page 179

* NO-Modifi ed Hemoglobins and Uses Therefor. #7,202,340. Assigned to Duke Univer-sity (Durham, NC). A solution comprising nitrosyihemoglobin and one or more electron acceptors selected from the group consisting of superoxide dismutase, nicotinamide adenine dinucleotide, ascorbate and fi ve other moieties identifi ed in the patent.

* Stabilized Hemoglobin Solutions. #7,202,341. Assigned to Northfi eld Laboratories, Inc. (Evanston, IL). A packaged polymerized hemoglobin solution having an oxyhemo-globin concentration of less than about 15% sealed within a fl exible container comprising a polymer fi lm having an oxygen permeability of about 0.05 to about 0.17 cc/m2 per 24 hours per atmosphere at about 5°C.

* Generation of Hematopoietic Cells from Multipotent Neural Stem Cells. #7,204,979. Assigned to Neurospheres Holdings Ltd. (Alberta, Canada). A method of generating hematopoietic cells from human multipotent neural stem cell progeny. These neural stem cell progeny are administered to a hematopoietic-inducing environment – specifi cally the circulatory system, spleen or thymus – that induces them to produce hematopoietic cells.

* Method of Treating Diseases with Activated Protein C. #7,204,981. Assigned to Eli Lilly and Company (Indianapolis, IN). A method of treating a human patient suffering from a disease or pathological condition selected from the group consisting of infl ammatory bowel disease, vasculitis, renal ischemia, and pancreatitis, comprising administering about 1 µg/kg/hr to about 50 µg/kg/hr of recombinant human activated protein C by continuous infusion for about 1 to about 240 hours.

* Recombinant RSV Virus Expression Systems and Vaccines. #7,205,013. Assigned to MedImmune Vaccines, Inc. (Mountain View, CA). An immunogenic composition comprising a live-attenuated respiratory syncytial virus (RSV) particle which comprises an RSV antigenome or genome containing a C-terminal truncation of the M2-1 protein, wherein the virus exhibits a lower degree of virulence as compared to a wild type RSV.

* Methods for Treating Disease and Forming a Supplemented Fibrin Matrix. #7,208,179. Assigned to The American National Red Cross (Rockville, MD). A method of using a supplemented tissue sealant composition to prevent or treat a disease in a patient. The tissue sealant comprises an effective amount of demineralized bone matrix as a supple-ment and fi brinogen, or a derivative metabolite thereof, in an amount which is capable of forming a fi brin matrix. Additional properties and behaviors of the supplemented tissue sealant are described in the patent.


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Page 180

August 15, 2007FDA Workshop/Licensure of Aphresis Blood ProductsLister Hill Center AuditoriumBuilding 3ANational Institute of HealthBethesda, MDTel: 301-827-6129Email: [email protected]

August 16-17, 2007Blood Products Advisory CommitteeDoubletree Hotel and Executive Meeting Center8120 Wisconsin AvenueBethesda, MD 20814Tel: 301-652-2000

September 14-16, 2007Annual Meeting of the European SocietyFor Paediatric Haemoatology and Immunology (ESPHI)Athens, GreeceTel: +30 2107 499 300Fax: +30 2107 705 752Email: [email protected]

September 17-20, 200747th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)McCormicks Place Chicago, ILTel: 202-942-9248Email: [email protected]: www.icaac.org

September 24-25, 2007WFH Global Forum 2007Delta Centre-VilleMontreal, CanadaTel: 514 394-2837Email: [email protected]: www.wfh.org

October 14-17, 2007Australian and New Zealand Society of Blood TransfusionGold Coast Convention & Exhibition Centre, QueenslandBrisbane, AustraliaTel: +61 8 8363 1307Email: [email protected]: anzsbt.org.au

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VOLUME 24 ISSUE 12 JULY 2007 - Marketing Research Bureau · international blood/plasma news JULY 2007 Page 168 * NABI BIOPHARMACEUTICALS and KEDRION S.p.A. have signed a European