• Affectis Pharmaceuticals AG, of Munich, Germany, signed a collaboration agreement with Tokyo-based Mitsubishi Pharma Corp. to develop therapeutics for affective disorders. Under terms of the agreement, Affectis will apply its target validation technology and exclusive animal models for the validation of Mitsubishi's gene targets involved in depression and anxiety.

• Atugen AG, of Berlin, and Asinex Ltd., of Moscow, announced a long-term drug discovery and development collaboration for a protein kinase target during the 3rd annual BioPartnering North America conference in Vancouver, British Columbia. Atugen said it will contribute work in target discovery and in vivo screening, while Asinex will handle drug design, medicinal chemistry and in vitro screening, with the goal of finding cancer compounds. The collaboration will be performed on a shared-risk basis, and future revenues will be equally divided between the companies.

• Barrier Therapeutics Inc., of Princeton, N.J., reported the acquisition of the U.S. and Canadian rights to Solage (mequinol 2 percent, tretinoin 0.01 percent) topical solution from Moreland Enterprises Ltd. Barrier made an initial cash payment of $3 million and will make future payments totaling up to $2 million, depending upon future sales of the product. Barrier is being assigned all U.S. and Canadian marketing authorizations, patents and trademarks for the product and is purchasing all existing inventory. The patent rights include U.S. and Canadian patents covering Solage's pharmaceutical composition and methods of use until 2010.

• Benitec Ltd., of Queensland, Australia, signed an exclusive license agreement with the Garvan Institute of Medical Research in Sydney, Australia, to use Garvan's Hot Mouse technology, which features a genetically modified mouse that lacks the c-Cbl gene. Benitec has rights to develop RNA interference-based drugs for diabetes, obesity and related disorders. The companies also entered discussions for a research collaboration to develop those therapies.

• BioBalance Corp., of New York, said the FDA has stated it will require additional information from the company regarding BioBalance's investigational new drug application to begin trials with Probactrix in pouchitis. The FDA is expected to formally communicate the precise nature of those outstanding issues in writing to BioBalance within 30 days, though the company anticipates communicating with the FDA in the interim. Probactrix is a single strain of non-pathogenic E. coli that originally was isolated from the intestinal microflora of a healthy volunteer. It is thought to work by inhibiting the growth of pathogenic bacteria in the digestive tract, BioBalance said.

• Biosite Inc., of San Diego, exercised a semi-exclusive license for research and diagnostic purposes to a target under its agreement with Incyte Corp., of Wilmington, Del. The company also might use an additional 50 target proteins, and antibodies that bind to those proteins, for research purposes. If Biosite exercises an exclusive option, it could receive a license to any of the targets for diagnostic purposes. Incyte has received up-front fees, and it will receive milestones and royalties if Biosite develops and commercializes diagnostic products related to the targets.

• Boston Life Sciences Inc., of Boston, effected a 1-for-5 reverse stock split that became effective at 5 p.m. EDT Friday. Stockholder authorization was obtained at a special meeting of stockholders on Friday. In connection with the reverse split, the number of common stock shares were adjusted from about 34.5 million to about 6.9 million. Stockholders also approved an amendment to the company's certificate of designations, rights and preferences of Series E cumulative convertible preferred stock, providing for mandatory conversion of all outstanding shares of Series E preferred stock into common stock upon the election of the holders of 75 percent or more of the outstanding Series E preferred stock.

• DOR BioPharma Inc., of Miami, began human testing of RiVax, a recombinant vaccine designed to protect against ricin toxin. The Phase I trial is a dose-escalating study in which volunteers will receive three monthly intramuscular doses of vaccine. Blood from the volunteers will be tested for ricin-neutralizing antibodies prior to each injection and regularly for six months, with the final efficacy measure one year after the first injection.

• Dr. Reddy's Laboratories, of Hyderabad, India, initiated Phase I trials of its cardiovascular drug candidate RUS 3108. The trials are being conducted in Belfast, Ireland, and will explore the safety and pharmacokinetic profile of the candidate in humans. It is the first time the company is testing a drug in Europe. RUS 3108 is being developed for the treatment of atherosclerosis.

• Eyetech Pharmaceuticals Inc., of New York, said the Centers for Medicare and Medicaid Services has posted, effective Jan. 1, that the Medicare part B allowable for Macugen (pegaptanib sodium injection) is 106 percent of average sales price, or $1054.70 per injection. Macugen was approved on Dec. 17 in neovascular (wet) age-related macular degeneration. The drug is partnered with Pfizer Inc., of New York.

• GeneGo Inc., of St. Joseph, Mich., a provider of databases and software for systems biology, said it will receive a Phase I Small Business Innovation Research grant from the National Cancer Institute in Bethesda, Md., for elucidation and analysis of cellular networks implicated in breast cancer. GeneGo's MetaCore, a systems biology platform for mining of high-throughput experimental data, will be used for analysis.

• Hemispherx Biopharma Inc., of Philadelphia, said it is collaborating on further studies with U.S. government-sponsored laboratories to determine the potential of antiviral activity of Alferon N against avian influenza. The company said previous experimental research showed that low doses of Alferon N added to the water and food supply of the bird population helped reduce the death rate and produced healthier weight in birds vs. placebo. Alferon N (interferon alfa-n3, human leukocyte derived) is a purified, glycosylated, multispecies alpha interferon product sold in the U.S. for refractory papilloma infections.

• JDS Pharmaceuticals LLC, of New York, and Synthon Pharmaceuticals Ltd., of Chapel Hill, N.C., entered a co-promotion agreement for Lithobid (lithium carbonate), a brand of twice-daily lithium carbonate for the treatment of bipolar disorder. Synthon will co-promote Lithobid through its sales force of about 50 representatives. Financial terms of the agreement were not disclosed.

• MDS Pharma Services, of Toronto, said it met with the FDA as part of an ongoing dialogue on a plan for reviewing bioequivalence studies conducted at the company's Montreal bioanalytical facility. The studies will be reviewed by priority based on specific criteria described in the plan, following appropriate review processes and quality assurance checks.

• Metabasis Therapeutics Inc., of San Diego, said the article "Liver-Targeted Drug Delivery Using HepDirect Prodrugs" was published in the February issue of The Journal of Pharmacology and Experimental Therapeutics. The article presented evidence that HepDirect prodrugs provide a strategy for targeting drugs to the liver and achieving more efficacious therapies to fight chronic liver diseases, such as hepatitis B, hepatitis C and primary liver cancer. The evidence includes preclinical results from studies of pradefovir mesylate (previously MB06866, or remofovir) for hepatitis B and MB07133 for primary liver cancer, Metabasis said.

• Neose Technologies Inc., of Horsham, Pa., filed a prospectus supplement related to an underwritten public offering of 7 million shares of common stock under an existing shelf registration statement. Neose expects to grant the underwriters a 30-day option to purchase up to about 1.1 million shares to cover overallotments. UBS Investment Bank is acting as the sole book-running manager, while JPMorgan Securities Inc. and Jefferies & Co. Inc. are acting as co-managers.

• Northfield Laboratories Inc., of Evanston, Ill., said its underwriters have exercised in full their overallotment option and agreed to purchase an additional 675,000 shares of common stock. UBS Investment Bank, SG Cowen and Harris Nesbitt agreed to purchase a total of about 5.2 million shares of Northfield's stock, bringing the company additional gross proceeds of about $10.1 million. Total gross proceeds for the offering come to about $77.6 million. (See BioWorld Today, Feb. 7, 2005.)

• Nuvelo Inc., of Sunnyvale, Calif., completed its public offering of 8.5 million shares of common stock, plus 1.3 million shares in overallotments, and announced gross proceeds of $73 million. UBS Securities LLC, acted as sole book-running manager, with Deutsche Bank Securities Inc. as co-lead manager. CIBC World Markets Corp. and Needham & Co. Inc. acted as co-managers. The company said proceeds will be used for general purposes, including trials of its lead product candidate, the clot-dissolving drug alfimeprase. (See BioWorld Today, Feb. 3, 2005.)

• Odyssey Pharmaceuticals Inc., of Florham Park, N.J., moved into new headquarters in Florham Park. Odyssey, a subsidiary of Pliva d.d., of Zagreb, Croatia, said the move represented its separation from Pliva and marks the company's growth following the August launch of Sanctura, a product to treat overactive bladder.

• Perlegen Sciences Inc., of Mountain View, Calif., said increased worldwide public and private support will enable the company to generate more data for the International HapMap Consortium to create a haplotype map of the human genome. New financial contributions came from governments, health organizations and pharmaceutical companies. Perlegen received a grant in September from the National Human Genome Research Institute to support the HapMap project, with the original funding to cover the generation of more than 600 million genotypes.

• Portola Pharmaceuticals Inc., of San Francisco, initiated a Phase Ib trial for the company's lead cardiovascular therapeutic program, an oral Factor Xa inhibitor. If developed, the product would address the market opportunity for the prevention and treatment of venous thrombosis and for the prevention and treatment of thromboembolic complications in patients with atrial fibrillation and in patients who have a myocardial infarction. Factor Xa is the enzyme responsible for converting prothrombin to thrombin.

• Protemix Corp., of Auckland, New Zealand, is opening an office in San Diego, where Larry Ellingson will serve as new CEO. Ellingson is a former Eli Lilly and Co. executive and current chairman of the American Diabetes Association. He will focus on extending and developing Protemix's commercial relationships, in particular, to progress Laszarin, its lead compound, through Phase III trials in heart failure in people with diabetes. He also will be responsible for developing the corporate team covering regulatory affairs, clinical trials and business development.

• Targeted Genetics Corp., of Seattle, said a Phase I trial of tgAAC09, a recombinant adeno-associated viral vector-based HIV/AIDS vaccine candidate, began in India as part of a development program under way in Germany and Belgium. Study collaborators include the International AIDS Vaccine Initiative, the Indian Council of Medical Research, the National AIDS Control Organization and researchers at Columbus Children's Research Institute and the Children's Hospital of Philadelphia. The study will enroll up to 30 volunteers in India who are not infected with HIV to receive a single intramuscular injection.

• Tripos Inc., of St. Louis, and BioTie Therapies Corp., of Turku, Finland, entered a partnership to enhance BioTie's drug discovery efforts, which include medicines for the treatment of dependence disorders, inflammatory diseases and thrombosis. Tripos will identify and optimize backup series for one of BioTie's key drug discovery programs. Tripos then will create compound libraries for in-house screening by BioTie.

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