VOLUME 24 ISSUE 1 AUGUST 2006

BUSINESS BRIEFS 1

BLOOD & BIOTECHNOLOGY 5

RESEARCH & DEVELOPMENT 7

PLASMA FRACTIONATION NOTES 9

PRODUCT SAFETY UPDATE 10

PEOPLE 11

NEW PRODUCTS 12 RECENT U.S. PATENTS 12 MEETINGS / SUBSCRIPTION FORM 15

____________________COMPANIES IN THIS ISSUE__________________AETHLON MEDICALAMERICAN HOMECARE (AHF)AMERICAN RED CROSSAMPERSAND VENTURESAPEX BIOSCIENCEAPHIOSASTELLAS PHARMAAVENTIS BEHRINGAVIGENBaxter BioScienceBAYER BIOLOGICAL PRODUCTSbioMérieuxBIOMET BIOLOGICSBIO-RAD LABORATORIESCANADIAN BLOOD SERVICESCANGENECENTOCORCERBERUS CAPITAL MGMTCERUSCHIRONCORDISDADE BEHRINGDAEWOONG PHARMACEUTICALDELTA BIOTECHNOLOGY

DYAXGENENTECHGTC BIOTHERAPEUTICSINHIBITEXINTERCELL AGJOHNSON & JOHNSONLEO PHARMA A/SLIFE SERALIFE THERAPEUTICSMedImmuneNORTHFIELD LABORATORIESNOVARTISORTHO CLINICAL DIAGNOSTICSPHARMING GROUPPURISSIMUSPYRAMID BIOLOGICALSSTEM CELL INTERNAL VENTURET.A.C. THROMBOSISTALECRIS BIOTHERAPEUTICSThermoGenesisTRINITY BIOTECHViaCellViRexx MedicalZLB BEHRING

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BUSINESS BRIEFS

* Through its centralized EMEA procedure, the European Commission has granted marketing authorization to GTC BIOTHERAPEUTICS’ ATryn recombinant human antithrombin; this approval applies to all 25 countries in the European Union. ATryn is indicated for the prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency. ATryn is the first transgenically produced human therapeutic protein to be approved anywhere in the world. In this instance, the product is purified from the milk of goats created with a transgene for human antithrombin. Antithrombin is a naturally occurring plasma protein with both anticoagulant and anti-inflammatory properties. Several plasma-based antithrombin products purified from source plasma are currently available.

The EC approval of ATryn follows a recent positive opinion from the European Medi-cines Agency’s Committee for Medicinal Products for Human Use (CPMP) (see the June issue of International Blood/Plasma News). GTC’s partner, LEO PHARMA A/S, will negotiate reimbursement rates with health authorities in each EU country, and establish marketing and sales efforts throughout Europe. GTC will continue to manufacture ATryn, receiving a transfer price as well as a royalty on commercial sales. Market launch is targeted for the second quarter of 2007 as reimbursement rates are finalized, according to GTC.

* Prior to EC marketing approval of its ATryn transgenic antithrombin, GTC BIOTHER-APEUTICS announced that it has obtained agreements from new and existing institutional investors to purchase 12 million shares of GTC’s common stock at a price of $1.38 per share – the closing bid price immediately before entering in to the binding agreements for the transaction. Under the terms of the financing, GTC will also issue 10-year warrants to purchase an aggregate of 7.8 million additional shares at an exercise price of $1.4145 per share.

These shares and warrants are being offered by the company under a shelf registration statement previously filed with the U.S. Securities and Exchange Commission. GTC estimates gross proceeds from the financing will be approximately $17.5 million, to be used for general corporate purposes.

* The Irish hemostasis products firm TRINITY BIOTECH has agreed to acquire the hemostasis diagnostics business of bioMérieux, including its MDA, MTX and Thrombolyzer lines. While this deal will assure that its customers will “continue to enjoy high-quality service” through Trinity, bioMérieux will attain its goal of “con-solidating its expansion around its strategic product ranges,” according to a senior company official. The total value of the deal, according to bioMérieux, could amount to about $60 million once all terms are finalized.

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* In 2005, the U.S. plasma fractions market reached $2.6 billion (plasma products only), a 15.5% increase from the previous year. Including licensed recombinant coagulation factors, the market reached $4.2 billion, up 13.9% from 2004. ZLB BEHRING was the market leader, followed by Baxter BioScience. Over the past 18 months, these events influenced the U.S. plasma products market:

• A strong demand for albumin which was somewhat unexpected, as the market had become accustomed to large quantities of albumin available at low price. This increased demand was attributed in part to the depletion of the past years’ excess inventories. Some 119 tons of albumin were used in 2005 (9.53 million vials, 12.5 grams).

• At the same time, the IVIG demand continued to increase, as the number of patient cases in need of IVIG therapy kept growing. In 2005, About 30.4 million grams of polyvalent IGIV were sold in the U.S. (12.17 million vials, 2.5 grams), or 107 kilograms per million population. The price of IVIG also went up to an average of $47.50 per gram, and possibly well over $55 per gram by mid-2006.

• In response to the above trends, and in anticipation of further market growth both domestically and abroad, source plasma collections went up. A number of plasma collection centers were opened or re-opened, while fractionators appeared poised to increase plasma processing throughput in 2007.

• Bayer AG divested the assets of its Biological Products Division to a newly formed entity named TALECRIS BIOTHERAPEUTICS, controlled by CER-BERUS CAPITAL MANAGEMENT and AMPERSAND VENTURES. The sale, which took effect on April 1st, 2005, amounted to approximately $590 mil-lion.

• The AMERICAN RED CROSS withdrew from the plasma derivatives busi-ness in July 2005, and began selling its recovered plasma to Baxter under a new, long-term plasma procurement contract.

• In January 2006, ZLB BEHRING received FDA approval for Vivaglobin, a new 16% liquid, pasteurized subcutaneous immune globulin indicated for the treatment of primary immune deficiency.

• In 2005, approximately 1.5 billion units of recombinant and plasma-derived fac-tor VIII concentrates were used in the U.S. The country’s factor VIII ratio was 5.7 international units per capita.

• In the coming months, reimbursement and cost containment issues, among others, will continue to impact the market dynamics for plasma products. The Market-ing Research Bureau’s newly completed report entitled The Plasma Fractions Market in the United States – 2005 offers a more detailed analysis of the U.S. market.

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* ThermoGenesis has entered into a development, license and supply agreement with BIOMET BIOLOGICS under which ThermoGenesis ̓fibrinogen harvesting technology will be adapted and integrated with Biometʼs Clotalyst System to cre-ate a product that can generate autologous fibrin sealant in less than 30 minutes. Biomet Biologics, a wholly-owned subsidiary of BIOMET, also plans to combine the ThermoGenesis fibrinogen disposable with “future autologous therapies to manufacture autologous fibrin sealant in a peri-operative setting.”

Biomet Biologics has agreed to pay ThermoGenesis up to $1 million in milestone pay-ments to develop this new fibrinogen disposable, as well as additional revenues upon commencement of sales. Biomet Biologics will be responsible for regulatory submis-sions and any preclinical or clinical studies that may be necessary to secure approvals. ThermoGenesis originally developed the Clotalyst System, which it identifies as the “Thrombin Processing Device” (TPD); this disposable kit for producing autologous thrombin is now sold by Biomet Biologics in Europe as a stand-alone product and as a component of kit for making autologous platelet gel.

* Legislation has been introduced in the U.S. House of Representatives that would require Medicare to cover and pay for all aspects of home infusion therapy – drugs, supplies, equipment and professional services – under its long standing “Part B” benefit program. Because current policies deny coverage for the professional ser-vices, special equipment and supplies required to properly administer home infusion drugs, Medicare beneficiaries without other health insurance have not been able to take advantage of home infusion therapy; typically they receive medically necessary IV-administered drugs in private medical offices or hospital outpatient clinics.

Medicareʼs new “Part D” drug benefit program, which covers many drugs commonly infused by providers in the home setting, also does not cover supplies, equipment or professional services. Earlier legislative initiatives introduced in 2001 and 2003 to expand access of Medicare beneficiaries to home infusion therapy failed to become law. The current measure is called H.R. 5791 – the Medicare Homme Infusion Consolidated Coverage Act of 2006.

* ORTHO CLINICAL DIAGNOSTICS has launched a new diagnostic test for Chagas disease throughout Europe. Also called American trypanosomiasis, Chagas disease is an infection transmitted by an insect vector or by blood transfusion, and is caused by the parasite Trypanosoma cruzi.

In clinical trials, the company reports that it Chagas test demonstrated 100% sensitiv-ity to all geographically diverse samples tested and specificity of more than 99.99% in blood donors ̓samples. This test will be used for screening blood donations and testing blood donors previously deferred due to travel in South America. The assay can also be used for the serodiagnosis of Chagas disease.

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* The Italian medicines agency (AIFA) has announced additional price reductions for pharmaceutical products ranging from 4.4% to 5%, according to the July 7 issue of the Gazzetta Ufficiale. These price cuts will not affect plasma derivatives or recombinant DNA-based products, which were specifically exempted from the new policy.

* NOVARTIS has announced plans to purchase the rights to an experimental vac-cine against Japanese encephalitis from Australia-based INTERCELL AG. This €37 million deal is reportedly contingent on results of late-stage studies of “IC51.” The agreement between the two firms grants Novartis first negotiation rights to certain existing product candidates derived from Intercell’s proprietary technology. These prospective vaccines have been granted European orphan drug status, protecting them from competing Japanese encephalitis virus vaccines for up to 10 years.

With its acquisition of CHIRON last year, Novartis now has a portfolio of vaccines against such pathogens as hepatitis A, cholera and typhoid.

* The U.S. Department of Health and Human Services (HHS) has exercised its option to purchase 10,000 doses of anthrax immune globulin (AIG) from CAN-GENE, under a modification of an earlier development and supply agreement. This AIG will be stockpiled and made available for treating or preventing inhalational anthrax, which is an acute infectious disease caused by inhaling spores of the bacterium Bacillus anthracis. The base value of this purchase is approximately $143 million, but optional “task orders” by HHS – including maintaining product manufacturing or additional clinical testing in special populations – could increase the final value of the contract.

This order follows successful preliminary efficacy testing of AIG conducted earlier under the HHS contract, which was originally signed in September 2005. Delivery of these doses will begin in the latter part of 2007 and are to be completed by the end of 2009. Cangene will receive payments following the delivery of these doses of usable product to the U.S. “Strategic National Stockpile” of agents intended for use in the event of bioterrorism. The contract also requires that Cangene apply for and receive authorization for marketing of AIG from the U.S. FDA, which triggers a supplemental payment. AIG is manufactured from equine plasma.

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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: mrb_ibpn@earthlink.net

http:// www . marketingresearchbureau.com

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BLOOD & BIOTECHNOLOGY

* Edmonton, Alberta-based ViRexx Medical has initiated a Phase I trial of its novel chimeric vaccine targeting hepatitis B. This safety study of HepaVaxx B, the company’s lead vaccine candidate based on its proprietary “Chimigen” platform, is scheduled to enroll 15 healthy volunteers at the McGill University Health Centre’s Vaccine Study Centre.

HepaVaxx B consists of a recombinant chimeric molecule comprising a hepatitis B viral antigen and a portion of a murine monoclonal antibody. The molecule is designed to target dendritic cells, which are known to participate in antigen presentation and initiation of an immune response.

* ViaCell has signed a collaboration agreement with the STEM CELL INTERNAL VENTURE (SCIV) arm of CENTOCOR to evaluate ViaCell’s cord blood-derived multipotent stem cells in preclinical testing as a potential treatment for cardiac disease. This collaboration, which is also supported by the Biologics Delivery Systems Group of CORDIS, will focus on dosing, delivery and targeting of ViaCell’s cord blood stem cells using Cordis’ NOGA delivery system. Both Centocor and Cordis are JOHNSON & JOHNSON companies.

Under terms of the agreement, ViaCell will receive an initial upfront payment, and all partners will share costs associated with this effort. SCIV will also have the first right to negotiate a collaboration with ViaCell on the clinical development and commer-cialization of a cardiac product offering based on ViaCell’s cord blood stem cells.

* PHARMING GROUP NV has received Fast Track designation from the U.S. FDA for its recombinant human C1 inhibitor (rhC1INH) for the treatment of heredi-tary angioedema (HAE). The Fast Track designation provides an expedited review process for products used for the treatment of serious or life-threatening diseases with limited treatment options, and where the product has the potential to have a positive effect on the course of the condition. This designation also allows the sponsor more frequent access to the FDA, which can also reduce the typical review period.

Currently, there is no approved treatment modality available for HAE patients in the U.S. for the management of acute gastrointestinal or other localized attacks. Clinical studies of Pharming’s rhC1INH have shown that it leads to “rapid time to beginning of relief from the attack and reduces time to complete resolution,” according to the company. The product has already been granted Orphan Drug status for this indication, which provides a seven-year period of U.S. market exclusivity following approval.

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* By mutating the Factor VIII gene or deleting the B-domain of the molecule, col-laborators at Alameda, California-based AVIGEN and Queens University in Ontario, Canada have documented for the first time a gene therapy protocol that produces physiologically significant levels of Factor VIII for several years in dog and mouse models. Unlike intact Factor VIII, which is an immunogenic protein, the selected mutants or B-domain deleted forms appear not to be as avidly recognized by the immune system.

The investigators claim that their method, which successfully utilized several types of adeno-associated virus (AAV) vectors, essentially “cured” the animals of their hemo-philia. They caution, however, that results that can be attained in mice or dogs may not necessarily translate directly to humans. Titled “Multiyear Therapeutic Benefit of AAV Serotypes 2, 6 and 8 Delivering Factor VIII to Hemophilia A Mice and Dogs,” this report appears in the July 1 issue of Blood.

* MedImmune has announced that it is expanding its efforts to develop live, at-tenuated intranasal vaccines against major viral pathogens that cause respiratory diseases. Two viruses of particular interest – respiratory syncytial virus (RSV) and human parainfluenza virus type 3 (PIV-3) – are among the leading causes of pediatric respiratory disease in the U.S. The company has initiated a second Phase I study of “MEDI-534,” a live, attenuated combination RSV/PIV-3 vaccine, in healthy RSV- and PIV-3 seropositive children between one and nine years of age. This double-blind, placebo-controlled, dose-escalation study is designed to evaluate the safety and tolerability of a single dose of the vaccine candidate.

To broaden its development options, MedImmune has entered into a Cooperative Re-search and Development Agreement (CRADA) with the National Institute of Allergy and Infectious Diseases (NIAID), an arm of the U.S. National Institutes of Health. Through this CRADA, MedImmune and NIAID scientists will work to develop live, attenuated intranasal vaccines designed to reduce the consequences of disease caused by RSV, PIV types 1, 2 and 3, and human metapneumovirus (hMPV). These viruses are responsible for more than half of all hospitalizations for pediatric respiratory tract disease, and can cause bronchiolitis, pneumonia and/or croup.

* CANGENE has filed a New Drug Application for its recombinant human growth hormone product with the U.S. FDA; the submission has been accepted for review. Called Accretropin, Cangene’s rhGH was tested for its ability to address short stature in children with growth hormone deficiency and girls with Turner Syndrome. This product, which is identical in sequence to naturally produced human growth hormone of pituitary origin, is Cangene’s first recombinant biopharmaceutical to be filed with the U.S. FDA.

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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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RESEARCH AND DEVELOPMENT

* New evidence suggests that measurement of thrombin generation using a commercially available assay can identify patients who are unlikely to suffer a recurrent venous thromboembolism (VTE) in the months following a VTE, and therefore may not require long-term anticoagulation therapy. According to a report by investigators at the University of Vienna in the July 26 issue of the Journal of the American Medical Association, patients typically receive anticoagulation with a vitamin K antagonist for at least three to six months after experiencing a VTE. But after stopping the therapy, up to one-third of patients will experience a recurrence, with an associated fatality rate of about 5%.

The researchers followed 914 patients who had experienced a first spontaneous VTE for 47 months. All patients had, on average, stopped vitamin K antagonist therapy three months earlier. The thrombin generation rate was significantly lower in patients who remained free of VTEs during follow-up. As compared with thrombin genera-tion greater than 400 nM, values between 300 and 400 nM and below 300 nM were respectively associated with 58% and 63% lower risk of a recurrent VTE. Roughly two-thirds of patients had values below 400 nM, and their risk of recurrence was 60% lower than that of patients with values above 400 nM (p<0.001). An interventional study is now in progress to see if patients treated according to a thrombin generation-driven protocol experience lower VTE rates in relation to the standard fixed treatment period approach. Noting that “a D-dimer test showed a similar predictive ability,” they suggested that combining this thrombin generation test with D-dimer assays may further improve the discriminative ability of clinicians.

* NORTHFIELD LABORATORIES has completed enrollment in its 720-subject Phase III trial of its investigational hemoglobin-based oxygen carrier, PolyHeme, in trauma victims experiencing hemorrhagic shock. Initiated in January 2004, the study eventually involved 32 U.S. Level I trauma centers in 18 states. The principal investigator, based at Denver Health Center, reported that his site enrolled 120 sub-jects, while other sites – particularly those that more recently joined the trial – reported enrolling very few or no subjects.

In subjects randomized to receive PolyHeme, up to six 50-gram units were admin-istered beginning in the pre-hospital (field) setting by paramedics, continuing for up to a total of 12 hours in the hospital in lieu of red blood cell transfusions. Control group subjects received saline in the pre-hospital setting, followed by red blood cells as needed. The primary endpoint is 30-day mortality, with secondary endpoints that importantly include multi-organ failure. Northfield expects to report top-line results from its trial in the fall of 2006.

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* Looking for an explanation for why some patients with idiopathic thrombocytopenic purpura (ITP) are refractory to intravenous immunoglobulin, collaborators at CANA-DIAN BLOOD SERVICES and several leading Canadian and German university hospitals found that, in a mouse model, IVIG was ineffective in reversing ITP induced by anti-GPIbx antibodies.

These results suggest that some cases of ITP may be mediated by Fc receptor (FcR)-independent mechanisms, while others – including ITP found to be co-associated with antibodies directed against the platelet surface glycoprotein GPIIbIIIa in about 80% of patients – are mediated by Fc-dependent mechanisms which are thought to be responsive to IVIG’s “Fc receptor blockade” activity. These research findings were presented at the recent 9th European Symposium on Platelet and Granulocyte Immunobiology in Norway.

* Noting that anti-D immunoglobulin administered intravenously for patients with idiopathic thrombocytopenic purpura (ITP) may result in fever, chills, headache, nausea, intravascular hemolysis and even disseminated intravascular coagulation, German researchers based in Berlin and Munich showed that 22 Rh D-positive patients who had experienced acute adverse reactions to IV anti-D had no local complications or clinically relevant hemolysis after subcutaneous administration of anti-D products. A total of 0.22 mL/kg of ZLB Behring Rhophylac or Rhesogam was administered over a period of three to five minutes. The platelet counts of 17 of the patients (77%) increased within one week, with a cessation of bleeding and initial upward movement of platelet counts within the first two days. Subcutaneous injec-tions were repeatedly effective in patients who required retreatment.

While subcutaneous anti-D administration took a day or two longer to achieve maximum effect on platelet counts than IV administration, the investigators noted that patients treated by this route need not be monitored as closely for signs and symptoms of acute adverse reactions as those treated with IV anti-D. These results were also presented at the 9th European Symposium on Platelet and Granulocyte Immunobiology.

* Intravenous infusion of a PEG-conjugated recombinant human albumin incor-porating synthetic iron-porphyrin restored mean arterial pressure, heart and respiration rate and mixed venous PO2 in rats that had been 65% isovolemically hemodiluted and 30% hemorrhaged. Scientists at Waseda University in Japan report that all animals survived, while rats injected with human albumin died. These findings appear in the September issue of Biomaterials.

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* A prospective, open-label, non-controlled, multicenter study of Baxter Bio-Science’s new 10% liquid intravenous IVIG in 22 adult subjects with primary immunodeficiency demonstrated that the product was well tolerated and had an “excellent” pharmacokinetic, efficacy and safety profile, according to clinical investigators in Sweden, Finland and Austria. Called KIOVIG, this product is puri-fied from an intermediate fraction using cation and anion exchange chromatography to yield a solution containing greater than 98% immunoglobulin G (IgG). It is subjected to three dedicated virus reduction steps: solvent-detergent treatment, nanofiltration and incubation at low pH and elevated temperature.

Each subject received nine infusions of 350- to 400 mg/kg per infusion, spaced at 21-day intervals. A total of 59 infection episodes occurred during the phase of the study during which the liquid IVIG was being administered; 39 were classified as mild and 20 were moderate. Just one episode was serious enough to require hospitalization. The frequency of infusion-related adverse events was similar to the frequency ob-served when these subjects received three doses of Baxter BioScience’s Gammagard S/D lyophilized IVIG prior to their course of treatment with the liquid product. The complete study findings appear in the May issue of Vox Sanguinis.

PLASMA FRACTIONATION NOTES

* Responding to “record high demand” and higher market prices for source donor plasma, LIFE SERA is now working to open 10 additional U.S. plasma collec-tion centers by next year. Two of these centers, both in California, are expected to be operational by the end of this month. Additional sites are currently being selected throughout the U.S. and long-term lease agreements are being signed, according to the company.

Life Sera says it has already ramped up plasma production dramatically, through its acquisition of PYRAMID BIOLOGICALS in October 2005 and expanded produc-tion at existing centers. Over the last six months, following the Pyramid purchase, plasma production has climbed from 20,000 liters to 26,000 liters a month. Every plasma collection center has increased its production since January, with a center in Pensacola, Florida reportedly boosting its output by 106%. The company has signed fixed long term plasma supply contracts with fractionators, which it says extend over the next five to eight years. With Life Sera’s growth in sales of source plasma and continuing hyperimmune plasma business, it hopes to help parent company LIFE THERAPEUTICS to achieve sales of A$120 million ($92.3 million) and EBITDA of A$24 million ($18.4 million) in fiscal 2006-2007.

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* PURISSIMUS, a privately held Argentinean fractionator, has recently completed a major overhaul and expansion of its facility in Buenos Aires. The plasma pro-cessing equipment has been refurbished to bring it to current GMPs. All the plasma products manufactured by Purissimus are solvent detergent-treated and nanofiltered. The plant’s capacity has been increased from about 75,000 to 300,000 liters per year, leading to the company’s claim that it is “Latin America’s largest fractionator.” Puris-simus fractionates mainly recovered plasma obtained from Argentine blood banks. Discussions are on-going with several countries in the region for toll fractionation. Purissimus’ product portfolio includes:

- IVIG (liquid, 5%)

- Albumin (5%, 4% 20% and 25%)

- Rh Immune Globulin (lyophilized, for IV injection)

- Tetanus Immune Globulin (a highly-purified IV form is in development)

- Factor VIII concentrate (undergoing stability studies)

In a few months, Purissimus, which also produces several non-plasma drugs, will celebrate its 70th anniversary. Plasma fractionation began in Buenos Aires in 1992.

PRODUCT SAFETY UPDATE

* Recognizing an urgent need for a simple method for viral inactivation of cryoprecipitate in developing countries, Egyptian and French collaborators have devised a method to subject minipools of five or six units of cryoprecipitate to four-hour incubation with either 2% TNBP or 1% TNBP and 1% Triton X-45 in sterile closed bags. Solvent-detergent separation is achieved by extracting the cryoprecipitate three times in its processing bag by mixing and decantation using 7.5% ricinus oil.

The 2% TNBP-treated cryoprecipitate is further subjected to a clarifying centrifugation step at 3800 G for 30 minutes. The final products are dispensed into individual bags and frozen at -30°C or lower. This treated cryoprecipitate showed excellent (>93%) mean recovery of Factor VIII, ristocetin cofactor von Willebrand factor (vWF:Rco), and clottable fibrinogen activity. The final content of TNBP and Triton-45 was <10 and <50 ppm, indicating excellent removal by the oil extraction procedure. The authors, whose report appears in the July issue of Vox Sanguinis, suggest that this technique should be considered for improving viral safety of cryoprecipitate intended for use in hemophilia A, von Willebrand disease, fibrinogen deficiency, or to prepare fibrin sealant.

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PEOPLE

* Donald E. Colburn, founder, president and CEO of AMERICAN HOMECARE FEDERATION (AHF), and a severe hemophiliac, died on July 17 from complica-tions of lung cancer at age 55. Kathy Ann Keenan, his wife and co-founder of AHF, passed away on May 5. Mr. Colburn was a lifelong advocate for people with bleeding disorders. He was actively involved in the bleeding disorders community on a nation-wide and regional bases. He served as a the executive director of the New England Hemophilia Association and took active part in several committees of the National Hemophilia Foundation (NHF). In the 1990’s, he chaired the NHF’s committee for “It’s Time for Cure,” a campaign to promote research for a cure for bleeding disorders, to which he donated $650,000 through AHF.

Upon Don Colburn’s death, Gary Mull was appointed as acting President of AHF. A person with a long experience in many aspects of hemophilia, Mr. Mull began his career as a sales representative with Cutter Biologicals. He then took up several posi-tions of increasing responsibility in hemophilia and coagulation products with Miles Pharmaceutical, which later became Bayer BP. In 1991, Mr. Mull moved to Alpha Therapeutic in Los Angeles, where he ultimately became Director, Coagulation & Hemostasis until the company was sold to Grifols. In 2005, he joined AHF as a special advisor to Mr. Colburn.

* Ms. Peggy Berry has joined DYAX as senior vice president, quality and regulatory affairs. A key responsibility will be to move “DX-88,” the company’s recombinant small protein currently in Phase III testing for treatment of hereditary angioedema, through the regulatory process. She will also direct the regulatory path for use of “DX-88” in on-pump CABG surgery. Ms. Berry started her career at the U.S. FDA in the Center for Drug Evaluation and Research, where she participated in the review New Drug Applications, served as a liaison between Drug Evaluation and the Office of Compliance, and wrote policy and procedure documents. She subsequently worked at Cato Research, Ilex Oncology, Dey LP, and AstraZeneca.

* San Diego-based AETHLON MEDICAL has appointed Harold “Hal” Handley, Jr., PhD as president, reporting to chairman and CEO James Joyce. Aethlon describes its development-stage Hemopurifier as “the first medical device to treat infectious dis-ease.” Dr. Handley was a co-founder of Idec Limited Partners, today known as Biogen Idec, and has over 20 years of management and research experience. Most recently he was executive vice president and chief scientific officer of Transvivo, a developer of biofiltration and catheter devices, where he oversaw all regulatory, clinical, patent and research efforts.

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NEW PRODUCTS

* DADE BEHRING (Deerfield, IL) is introducing the ProC Control to complement the company’s Factor V Leiden assay as a pathological control, with lot-specific values for the BCS system, Sysmex CA-7000 and CA-1500 systems. Activated protein C (APC) resistance is one of the major risk factors, and Factor V Leiden is the primary mutation responsible for APC resistance. For more information, call 1-800-242-3233 or 1-847-267-5300, or visit www . dadebehring.com.

* ORTHO CLINICAL DIAGNOSTICS (Raritan, NJ) has announced that the U.S. FDA has approved Genetic Systems HbsAg EIA 3.0, a product of BIO-RAD LABORATORIES, for use on The Ortho Summit System. This assay is used to qualitatively measure hepatitis B surface antigen in human serum and plasma to screen the blood supply for hepatitis B infection. The Ortho Summit System fully automates the processing of blood donation screening assays. All critical functions are moni-tored, controlled and documented to ensure stringent test standards are met. For more information, call 1-908-218-8287 or visit www . orthoclinical.com.

RECENT U. S. PATENTS

* Nucleic Acid Molecules Encoding Modified Factor VIII Proteins, Expression Products, and Methods of Making the Same. #7,033,791. Assigned to Emory University (Atlanta, GA). A DNA encoding modified human Factor VIII A2 domain, said DNA having one or more nucleotide substitutions resulting in a coding change at one or more amino acid positions chosen from positions 484-508 of SEQ ID NO:2, said change encoding an immunoreactivity-reducing amino acid at the chosen posi-tion.

* Method for the Stabilization of Chimeric Immunoglobulins or Immunoglobulin Fragments, and Stabilized Anti-EGP-2 SCFV Fragment. #7,033,798. Assigned to University of Zurich (Zurich, Switzerland). A method for stabilizing a chimeric immunoglobulin or immunoglobulin fragment (chimera).

* Human Thrombopoietin Comprising Glycosylation Sited at Residues 157 and 164. #7,037,491. Assigned to Daewoong Pharmaceutical Co., Ltd. (Seoul, Korea). A human thrombopoietin derivative which is derived from human thrombopoietin (hTPO) described by SEQ ID NO:30, by the introduction of at least one additional N-linked glycosylation site; and which comprises substitutions of Asn for Pro and Arg, respectively, at residues 157 and 164.

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* Inactivation of Viral Infectious Agents by Chemiluminescence Activated Light-Sensitive Compounds. #7,037,534. Assigned to Aphios Corporation (Woburn, MA). An antiviral complex, comprising an antiviral light sensitive compound, a phosphatase enzyme, and a chemiluminescence enhancer, wherein said antiviral light sensitive compound is selected from the group consisting of hypericin, pseudohypericin, and hypocrellin.

* Removing Compounds from Blood Products With Porous Particles Immobilized in a Matrix. #7,037,642. Assigned to Cerus Corporation (Concord, CA). A method of reducing the concentration of a low molecular weight compound in an aqueous cell-containing blood product, involving contacting the blood product batch-wise with an adsorption medium comprising porous adsorbent particles immobilized within a sintered matrix formed from polymeric particulate material and adsorbing said low molecular weight compound.

* Hematopoietic Stem Cell Proliferating Agents. #7,037,892. Assigned to Astellas Pharma Inc. (Tokyo, Japan). A method of proliferating hematopoietic stem cells in a mammal in need thereof, consisting essentially of administering IGF-I and either or both of M-CSF and G-CSF.

* Albumin-based Colloid Composition and Method of Use in Treating Hypovo-lemia and Multiorgan Dysfunction. #7,037,895. Assigned to Medical College of Ohio (Toledo, OH). A composition for treating hypovolemic conditions comprising at least one PEGylation product of an albumin-based colloid having a molecular weight excluded volume and a hydrodynamic radius sufficiently large to preclude the com-position from leaking through a patient’s capillaries wherein albumin has a molecular excluded volume and the molecular excluded volume of the PEGylation product is 16-fold larger the molecular excluded volume of the albumin.

* Methods for Purification of an Activated PEG Solution and for the Synthesis of a Modified Hemoglobin Solution. #7,038,016. Assigned to Apex Bioscience, Inc. (Raleigh, NC). A method of preparing a PEGylated hemoglobin solution that is sub-stantially free of contaminants, involving dissolving an activated polyethylene glycol a(PEG) in a solvent suitable for addition to a hemoglobin solution and in which said aPEG is stable.

* Antibody Purification. #7,038,017. Assigned to Genentech, Inc. (South San Fran-cisco, CA). A composition comprising a physiologically acceptable carrier and a mixture of antibody fragments comprising incorrectly disulfide linked light and heavy chains and antibody fragments comprising correctly disulfide linked light and heavy chains, wherein at least about 95% of said antibody fragments in said composition comprise correctly disulfide linked light and heavy chains.

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* Polypeptides Capable of Forming Antigen Binding Structures with Specificity for the Rhesus D Antigens, the DNA Encoding Them and the Process for Their Prepa-ration and Use. #7,038,020. Assigned to ZLB Behring AG (Bern, Switzerland). A purified polypeptide capable of forming antigen binding structures with specificity for Rhesus D antigens.

* Compositions and Methods for Selective Dissolution of Nascent Intravascular Blood Clots. #7,041,287. Assigned to Trustees of the University of Pennsylvania (Philadelphia, PA). A method for preferentially dissolving nascent intravascular blood clots in a subject as compared to effect on pre-existing haemostatic clots in the subject, comprising administering a plasminogen activator biocompatibly coupled to a red blood cell carrier.

* Methods and Reagents for Determining Protein S. #7,041,458. Assigned to T.A.C. Thrombosis and Coagulation (Aktiebolag, Sweden). A kit for assaying free protein S, included in which is a polypeptide ligand comprising the entire or essentially the entire protein S binding site in C4b-binding protein, which is capable of binding a free protein s at a first site.

* G-CSF and Albumin Fusion Protein. #7,041,478. Assigned to Aventis Behring L.L.C. (King of Prussia, PA). A recombinant fusion protein comprising G-CSF and albumin or an albumin variant, wherein the fusion protein has a higher plasma stability than unfused G-CSF and retains the therapeutic activity of unfused G-CSF.

* Staphylococcal Immunotherapeutics Via Donor Selection and Donor Stimulation. #7,045,131. Assigned to Inhibitex, Inc. (Alpharetta, GA). A method of obtaining a purified human donor immunoglobulin composition comprising an antibody titer to an S. aureus serine-aspartate repeat (Sdr) protein in combination with an antibody titer to an S. epidermidis serine-aspartate repeat protein, wherein both antibody titers are higher than that found in pooled intravenous immunoglobulin obtain from unselected human donors.

* Recombinant Fusion Proteins to Growth Hormone and Serum Albumin. #7,045,318. Assigned to Delta Biotechnology Limited (UK). A method of produc-ing a fusion protein of serum albumin and growth hormone, comprising (a) expressing from a host cell said fusion protein, wherein said host cell comprises a PRB1 promoter element operatively associated with a polynucleotide encoding said fusion protein; and (b) recovering said protein.

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September 2-7, 2006XXIXth International Congress of theInternational Society of Blood TransfusionCape Town, South AfricaTel: +31 20 679 3411Fax: +31 20 673 7306Email: isbt.capetown@eurocongres.com

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