• Advancis Pharmaceutical Corp., of Germantown, Md., entered an agreement with Innovex Inc., the commercialization division of Quintiles Transnational Corp., of Research Triangle Park, N.C., to provide contract sales and marketing services to Advancis. Terms of the agreement include the hiring, training and deployment of 75 sales representatives dedicated Advancis' 333-mg and 750-mg strengths of its cephalosporin antibiotic, Keflex capsules (cephalexin).
• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said the European Patent Office upheld key features of its Kreutzer-Limmer I patent, with claims covering small interfering RNAs that originally was granted in Europe on Aug. 28, 2002, and opposed by several parties. The amended patent claims cover certain structural requirements for siRNAs important for therapeutic activity.
• Celera Genomics, of Rockville, Md., and Medarex Inc., of Princeton, N.J., announced a collaboration on fully human antibodies for multiple cancer indications. The companies plan to select targets from Celera's portfolio, and Medarex expects to generate antibodies using its UltiMAb Human Antibody Development System. They plan to alternate the selection of antigen-antibody research to further develop and commercialize the antibodies independently. The selecting party will have full development and commercialization rights to products, with the other receiving milestone payments and royalties. In other news, Celera and Specialty Laboratories, of Valencia, Calif., signed an agreement granting Specialty a nonexclusive license to Celera's risk markers for cirrhosis. The agreement allows Specialty to select from among Celera's genetic findings to develop and commercialize a genetic test - a constellation of single nucleotide polymorphisms - that predicts risk of progression to liver cirrhosis in those infected with hepatitis C virus. Specialty would pay Celera an undisclosed up-front license fee upon validation of Specialty's test, and royalties on sales in the U.S.
• Corgentech Inc., of South San Francisco, changed its name to Anesiva Inc. (NASDAQ:ANSV), following approval by stockholders at the company's annual meeting, to reflect its focus on pain therapeutics.
• CV Therapeutics Inc., of Palo Alto, Calif. acquired rights to ranolazine in Asia following an amendment to its existing licensing agreement with Roche Palo Alto LLC, also of Palo Alto, adding rights to Japan, China, Korea and other Asian markets. Based on the amendment, CV now holds exclusive worldwide commercial rights to ranolazine. Extended-release ranolazine, branded Ranexa, is indicated in the U.S. for chronic angina in patients who have not achieved an adequate response with other antianginal drugs, and should be used in combination with amlodipine, beta-blockers or nitrates.
• Gene Logic Inc., of Gaithersburg, Md., saw its shares drop 33 percent on news that second-quarter and full-year revenue for its Genomics Division will be significantly lower than previously anticipated. As a result, the company is withdrawing its previously issued financial guidance for 2006 and 2007, and it is conducting a through review of its Genomics Division strategy. Shares of Gene Logic (NASDAQ:GLGC) lost 72 cents Thursday to close at $1.30.
• Generex Biotechnology Corp., of Toronto, entered contractual arrangements with Cardinal Health Inc., of Dublin, Ohio, to manufacture clinical trial batches of Generex Oral-lyn, an oral insulin spray product. Under the terms of the contract, Cardinal Health will formulate and fill clinical trial batches of the canisters at its manufacturing and analytical services facility in Research Triangle Park, N.C. Additional terms of the agreement were not disclosed.
• Geron Corp., of Menlo Park, Calif., signed an agreement with Corning Inc., of Corning, N.Y., to develop and commercialize synthetic surface matrices for the growth of human embryonic stem cells (hESCs). Corning would receive a license under Geron patents covering hESC growth, as well as a sublicense under the foundational hESC patents held by the Wisconsin Alumni Research Foundation. Resulting products would be sold by Corning subject to certain commercial use restrictions, and Geron would receive royalties.
• La Jolla Pharmaceutical Co., of San Diego, said its marketing authorization application has been accepted for review by the European Medicines Agency for Riquent (abetimus sodium), a drug candidate for lupus renal disease. The document was filed March 31. In the U.S., the company received an approvable letter for Riquent in October 2004, but the FDA required completion of another study for final approval, delaying a potential launch until 2008. (See BioWorld Today, Oct. 18, 2004, and March 31, 2005.)
• Sirion Therapeutics Inc., of Tampa, Fla., entered an exclusive licensing agreement with Senju Pharmaceutical Co. Ltd., of Osaka, Japan, for the U.S. rights to develop and market a topical ophthalmic emulsion containing the steroid compound difluprednate for the treatment of inflammatory eye diseases. Under the agreement, Sirion will have the rights to develop, use, obtain governmental approval for, manufacture, sell, distribute and promote difluprednate formulated as an ophthalmic emulsion and/or suspension throughout the U.S. and all U.S. territories and possessions. Other terms were not disclosed.