• ActivBiotics Inc., of Lexington, Mass., appointed Steven Gilman chairman and CEO. He previously was the company's president and CEO. Gilman succeeds Alan Dunton, who resigned as non-executive chairman earlier this year to become CEO of Panacos Pharmaceuticals Inc., of Watertown, Mass.

• Alethia Biotherapeutics Inc., and Emerillon Therapeutics Inc., both of Montreal, entered a collaboration for a discovery and functional validation program to identify new drug candidates for treating bone-related diseases such as osteoporosis. Emerillon will provide Alethia a list of genetic loci associated with an osteoporotic phenotype in mice. In return, Alethia will generate bone-specific cDNA libraries to help identify the genes. Furthermore, Alethia will conduct cell-based validation studies to determine the functional relevance of the genes provided by Emerillon. Terms of the deal were not disclosed.

• Astellas Pharma Inc., of Tokyo, and Theravance Inc., of South San Francisco, said Astellas submitted a marketing authorization application to the European Medicines Agency for telavancin, an injectable antibiotic, for the treatment of complicated skin and soft tissue infections in adults. A new drug application previously was filed with the FDA. (See BioWorld Today, Dec. 11, 2006.)

• AVI BioPharma Inc., of Portland, Ore., and collaborators presented preclinical data demonstrating effectiveness of Neugene antisense compounds against seasonal influenza A virus in mice. In experiments sponsored by AVI and conducted at Tulane University School of Medicine and the United States Army Medical Research Institute for Infectious Diseases, treated mice showed significantly reduced clinical signs (weight loss) and increased survival compared to control and untreated mice.

• Biolex Therapeutics, of Pittsboro, N.C., entered a collaboration with Merial Ltd., a joint venture between Merck & Co. Inc., of Whitehouse Station, N.J., and Sanofi-aventis, of Paris. They will develop animal health products using Biolex's LEX System, with a goal to provide Merial vaccine antigens. Biolex is entitled to research and development support and development milestones during the initial phase of the collaboration. Merial then may exercise an option regarding a worldwide license covering the use of the LEX System for the field of animal health.

• BioServe, of Beltsville, Md., said it acquired Genomics Collaborative from SeraCare Life Sciences Inc., of Oceanside, Calif. Genomics Collaborative facilitates biomarker discovery and validation through its Global Repository, a library of 600,000 human DNA, tissue and serum samples linked to data from 140,000 patients collected on four continents. Genomics Collaborative will operate as a fully integrated division of BioServe. Terms of the deal were not disclosed.

• Cel-Sci Corp., of Vienna, Va., said CEL-1000 alone increased the immune response against hepatitis B antigen, and that the combination of CEL-1000 and MAS-1, a water-in-oil adjuvant delivery system owned by Mercia Pharma Inc., of Scarsdale, N.Y., induced highly significant increases in specific anti-HBV antibodies. CEL-1000 previously was shown to be protective in animal-challenge studies against viruses and unrelated diseases, specifically herpes simplex virus, viral encephalitis and malaria.

• Cyberonics Inc., of Houston, implemented an organizational restructuring designed to enhance efficiency and reduce costs, which resulted in a 15 percent reduction in employee headcount. Cyberonics also announced the appointment of Daniel Moore as president and CEO. Reese Terry Jr., co-founder of Cyberonics and interim CEO, will remain on the board. The company said its focus is reinvigorating growth of its core epilepsy franchise, while continuing to rationalize its investment in the treatment-resistant depression indication and capitalize on the value of its intellectual property assets.

• CyDex Inc., of Lenexa, Kansas, licensed its Captisol technology to Proteolix Inc., of San Francisco. Proteolix will use the technology with a proteasome inhibitor, PR-171, which has shown promise in treating certain cancers such as multiple myeloma and mantle cell lymphoma. PR-171 is in Phase I trials. The technology is designed to improve water solubility, bioavailability and other characteristics of insoluble and/or unstable drugs. Terms of the deal were not disclosed.

• DiagnoCure Inc., of Quebec City, Quebec, said it secured exclusive worldwide rights to two molecular tests for colorectal cancer and an option to a CLIA-certified U.S. service laboratory to commercialize molecular cancer diagnostics tests. The colorectal cancer tests were licensed from Targeted Diagnostics & Therapeutics Inc., of Philadelphia, and are based on the detection of the GCC (guanylyl cyclase C) gene. TDT gets an initial payment of $2.2 million in DiagnoCure shares, and is entitled to milestone and royalty payments.

• GenomeQuest Inc., of Westborough, Mass., entered a collaboration with Servier, of Paris, to connect results from high-throughput microarray experiments to qPCR platforms from different vendors, including Servier reagent datasets. Deliverables to Servier include gene catalogs for human, mouse and rat and a companion visualization module that integrates Servier content with public and vendor reagent libraries. GenomeQuest retained the right to commercialize the software and know-how.

• Gen-Probe Inc., of San Diego, and 3M, of St. Paul, Minn., entered an exclusive worldwide collaboration to develop and commercialize rapid, easy-to-use nucleic acid tests to detect certain health care-associated infections, such as methicillin-resistant Staphylococcus aureus. Gen-Probe will be responsible for assay development, which 3M largely will fund. 3M will be responsible for integrating the assays onto one of its instrument platforms. 3M will manage clinical trials and regulatory affairs, and would handle global sales and marketing, with co-promotion assistance from Gen-Probe. Gen-Probe is entitled to milestone payments, and a share of resulting profits.

• GenVec Inc., of Gaithersburg, Md., said it will get up to $750,000 in additional funding under an amendment and extension of its agreement with the PATH Malaria Vaccine Initiative. This deal covers funding through the end of 2007. GenVec will continue advancing a multivalent malaria vaccine toward clinical evaluation. The multivalent vaccine was developed under an agreement with MVI now worth up to $3.9 million, for production and evaluation of adenovirus vectors containing genes for up to five malaria antigens. MVI is a nonprofit organization established through an initial grant from the Bill & Melinda Gates Foundation.

• Millenium Biologix Corp., of Kingston, Ontario, entered into an agreement with Medtronic of Canada Ltd., of Mississauga, Ontario, a division of Minneapolis-based Medtronic, and Warsaw Orthopedic Inc., of Warsaw, Ind., for the sale of MBC's resorbable synthetic bone graft technology, Skelite. Millenium will receive an undisclosed payment and potential milestone and contingent payments. The deal reflects Millenium's efforts over the past several months to find strategic partners or purchasers for its various technologies.

• Rosetta Genomics Ltd., of Rehovot, Israel, entered an agreement under which the Henry Ford Hospital in Detroit will provide it samples of metastases found in brain tissue. The samples then will be analyzed using Rosetta's miRdicator technology to determine the origin of the metastasis. Rosetta is using the samples in development of a microRNA-based diagnostic test to identify the site where metastases originate. Terms of the deal were not disclosed.

• Sciele Pharma Inc., of Atlanta, signed an exclusive license agreement with LifeCycle Pharma A/S, of Copenhagen, Denmark, to market fenofibrate in the U.S., Canada and Mexico, in 120-mg and 40-mg strengths. Fenofibrate is prescribed for the treatment of hyperlipidemia and triglyceridemia. LifeCycle will receive an up-front payment of $5 million, milestone payments of up to $12 million upon FDA approval and meeting certain sales targets, and tiered mid-teen to high-teen royalty payments on product sales. LifeCycle filed a new drug application with the FDA in October for the new formulation of fenofibrate (LCP-FenoChol). Sciele also entered a collaboration to use LifeCyle's MeltDose Technology for the lifecycle management of its products. LifeCycle is entitled to receive R&D reimbursement, development milestones and mid-single-digit royalties on eventual sales.

• Tekmira Pharmaceuticals Corp., of Vancouver, British Columbia, and Inex Pharmaceuticals Corp., also of Vancouver, said the spinout of Tekmira has been completed and that new common shares of Tekmira began trading on the Toronto Stock Exchange Monday under the symbol "TKM." Tekmira will continue the biotechnology business of Inex. Tekmira is developing drugs and delivery systems to improve the treatment of cancer. Inex shares were delisted from trading on the TSX. Inex said it will seek new opportunities outside the pharmaceutical industry under new management.

• Vical Inc., of San Diego, announced a successful final outcome upholding its Japanese Patent No. 3250802, "Expression of exogenous polynucleotide sequences in a vertebrate," covering the company's core DNA delivery technology. The Intellectual Property High Court in Japan confirmed that the parties that originally challenged the patent did not appeal the court's prior ruling by the deadline. As a result, the ruling upholding the patent is now final, it said.

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