• Aethlon Medical Inc., of San Diego, said it will initiate research studies to test the in vitro effectiveness of its Hemopurifier medical device to capture H5N1 avian influenza, through collaborations with Commonwealth Biotechnologies Inc., of Richmond, Va., and Battelle Biomedical Research Center. Terms of the deals were not disclosed.

• Amgen Inc., of Thousand Oaks, Calif., said the European Medicines Agency's Committee for Medicinal Products for Human Use communicated to marketing authorization holders of epoetins a proposal for amending prescribing information for erythropoiesis stimulating agents in the European Union, including its Aranesp (darbepoetin alfa). The CHMP made a number of proposals, including stipulating a uniform target hemoglobin range for all epoetins of 10 g/dL to 12 g/dL, with guidance to avoid sustained hemoglobin levels above 12 g/dL. Amgen said it will continue discussions with the EMEA to finalize the language and update product labeling accordingly.

• Asphelia Pharmaceuticals Inc., of San Diego, a Paramount BioSciences-founded company, hired Francois-Xavier Frapaise as president and CEO. He also is a director. The company, founded in August, is developing therapies for inflammatory bowel disease and other immunological and inflammatory disorders, including multiple sclerosis and asthma.

• BioNanomatrix Inc., of Philadelphia, and Complete Genomics Inc., of Mountain View, Calif., formed a joint venture that received an $8.8 million grant from the U.S. National Institute of Standards and Technology Advanced Technology Program. Funds will be used to try to develop a system capable of sequencing the entire human genome in eight hours at a cost of less than $100. Today, the cost of sequencing the roughly 3 billion base pairs in the human genome is more than $100,000, BioNanomatrix said. The joint venture has proposed adapting a novel DNA sequencing chemistry combined with linearized nanoscale DNA imaging to create a system that can "read" very long DNA sequences of greater than 100,000 bases with high speed and accuracy. The joint venture partners will provide matching funds for the project. Specific details on the joint venture were not disclosed.

• BrainCells Inc., of San Diego, licensed a development program from Taisho Pharmaceutical Co. Ltd., of Tokyo, that it will develop for central nervous system indications, including mood disorders. BCI plans to complete preclinical development of the lead compound, a neurogenesis promoter designated BCI-632, and advance it into clinical trials. Taisho retained rights to the program in Japan and China. BCI has rights in the rest of the world. Financial terms were not disclosed.

• Columbia Laboratories Inc., of Livingston, N.J., signed an exclusive, five-year license and supply agreement with Ascend Therapeutics Inc., of Herndon, Va. Ascend will be responsible for sales and marketing of Columbia's Prochieve 4 percent progesterone gel, which is approved for treating secondary amenorrhea. Ascend will purchase product from Columbia at a transfer price equal to 35 percent of its net selling price in a deal that includes increasing minimum annual purchase obligations.

• Dey LP, a Napa, Calif.-based, affiliate of Merck KGaA, and Critical Therapeutics Inc., of Lexington, Mass., said they launched Zyflo CR (zileuton) extended-release tablets. The product is approved for the prevention and chronic treatment of asthma in patients 12 and older. The Zyflo immediate-release formulation already was being marketed. Zyflo CR received FDA approval in May.

• Emergent BioSolutions Inc., of Rockville, Md., said it received a development contract valued at up to $9.5 million in support of nonclinical and clinical studies of the company's anthrax therapeutic, or AIG, product candidate. The candidate is an immune globulin being developed as an intravenous therapeutic for treatment of patients who present with symptoms of anthrax disease following exposure to anthrax. Funds are being provided by the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority. Earlier this week, Emergent entered a three-year contract with the federal government worth up to $448 million to supply of BioThrax anthrax vaccine for the nation's biodefense stockpile. (See BioWorld Today, Sept. 27, 2007.)

• Flynn Pharma Ltd., of Hitchin, UK, acquired exclusive marketing and distribution rights to DepoDur (morphine sulphate extended release liposome injection) for Europe and a number of other markets from Pacira Pharmaceuticals Inc., of San Diego. DepoDur is an extended-release formulation of morphine marketed in the U.S. by EKR Therapeutics Inc. Terms of the deal were not disclosed.

• Galapagos NV, of Mechelen, Belgium, and ProStrakan Group plc, of Galashiels, UK, said they achieved the third milestone under Galapagos' collaboration with Novartis AG, of Basel, Switzerland, related to antibodies for bone-related diseases. The undisclosed milestone triggered a payment of $1.5 million to Galapagos, of which about $1.13 million will go to ProStrakan as part of their December 2006 agreement. The collaboration initially was formed between Novartis and ProSkelia SASU (formerly a subsidiary of ProStrakan). The collaboration then transferred to Galapagos as part of its acquisition of ProSkelia from ProStrakan, which is entitled to 75 percent of milestone and royalty income from deals in place at the time.

• Genomatix Software GmbH, of Munich, Germany, said Sanofi-Aventis, of Paris, renewed its licenses for multisite access to Genomatix microarray products. Terms of the deal were not disclosed.

• Genzyme Corp., of Cambridge, Mass., affirmed its purchase price offer for Bioenvision Inc., of New York, at $5.60 in cash per outstanding common share as set forth in their merger agreement. Genzyme said the price is its best and final offer. Genzyme already owns about 22 percent of the outstanding shares of Bioenvision, whose shareholders are scheduled to vote on the merger Oct. 4. Genzyme announced the $345 million acquisition offer in May. Bioenvision's stock (NASDAQ:BIVN) fell 17 cents Thursday to close at $5.26.

• Immtech Pharmaceuticals Inc., of New York, said regulators in China granted fast-track status to Immtech's application for conducting a Phase III trial of pafuramidine, an oral drug candidate for treating Pneumocystis pneumonia. Immtech said pafuramidine is among the first drugs to be considered for fast-track status under new rules in China, and said the study will be conducted under a U.S. FDA protocol.

• ISTA Pharmaceuticals Inc., of Irvine, Calif., licensed exclusive North American rights to nasal-dosage forms of bepotastine, an investigational product for treating allergy symptoms, from Tanabe Seiyaku Co. Ltd., of Osaka, Japan. Last year, ISTA obtained exclusive North American rights to ophthalmic allergy applications of bepotastine, and has been developing an ocular formulation to treat the symptoms of ocular itching that accompany reactions to allergens. ISTA will pay Tanabe $2 million up front as well as potential milestone and royalty payments. ISTA also obtained right to develop other nasal bepotastine products and a future right to negotiate for a North American license to oral dosage forms of bepotastine for allergy treatment.

• MIV Therapeutics Inc., of Vancouver, British Columbia, and Smith & Nephew, of London, entered a research collaboration to develop new coatings and drug delivery systems for orthopedic devices. MIV's coatings and delivery systems are based on hydroxyapatite, a naturally occurring substance found in bones and teeth. Details on the deal were not disclosed.

• NeurogesX Inc., of San Carlos, Calif., said the European Medicines Agency accepted for review its marketing authorization application for NGX-4010, a product candidate for peripheral neuropathic pain. NGX-4010 is a dermal patch that has been studied in Phase III trial in patients suffering from peripheral neuropathic pain conditions. The product contains capsaicin, a TRPV1 agonist. The review process is being coordinated by the EMEA under the centralized procedure.

• Nuvelo Inc., of San Carlos, Calif., published data from a preclinical study of NU206 (R-Spondin1), describing the mechanism that regulates the Wnt pathway. By increasing the cell surface levels of low-density lipoprotein-receptor-related protein 6, NU206 is able to stimulate the Wnt pathway, a signaling pathway critical for cell growth and differentiation during homeostasis and pathogenesis, it said. The study appears in the Proceedings of the National Academy of Sciences.

• PharmAthene Inc., of Annapolis, Md., and Medarex Inc., of Princeton, N.J., said PharmAthene was awarded a contract for the advanced development of Valortim (MDX-1303), a fully human monoclonal antibody the companies are developing. The contract worth up to $13.9 million was awarded by the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority. Funds will support development of Valortim for use as an antitoxin therapeutic to prevent and treat inhalation anthrax infection.

• SIGA Technologies Inc., of New York, said its lead smallpox drug, ST-246, demonstrated 100 percent protection against death in cynomolgus monkeys showing signs of infection with monkeypox virus. The trial was conducted at the U.S. Army Medical Research Institute of Infectious Diseases. SIGA previously said ST-246 was shown to be safe to administer to humans as a once-a-day pill. SIGA's stock (NASDAQ:SIGA) gained 59 cents Thursday, or 16.3 percent, to close at $4.20.

• Theratechnologies Inc., of Montreal, granted OctoPlus NV, of Leiden, the Netherlands, exclusive worldwide rights to develop and commercialize its glucagon-like peptide-1 portfolio of analogues for the treatment of diabetes and other potential indications. OctoPlus' controlled-release technology will be applied to the GLP-1 compounds. Theratechnologies received an undisclosed up-front payment in the deal, and is eligible to receive up to €36 million (US$51 million) in milestone payments related to development, clinical phases and commercialization. It also could receive royalties on sales.

• Third Wave Technologies Inc., of Madison, Wis., said a U.S. district court in Wisconsin issued an order denying Gaithersburg, Md.-based Digene Corp.'s motion for reconsideration of the court's Markman opinion and order from July. In doing so, the court reaffirmed its Markman order, in which it agreed with all of Third Wave's definitions for the disputed patent claim terms in the case. A trial is scheduled for February.

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