¿ Alza Corp., of Mountain View, Calif., and Schering-Plough Corp., of Madison, N.J., won a recommendation for European approval of Caelyx in a new indication, the treatment of advanced ovarian cancer in women who have failed first-line platinum-based therapy. The European Commission will make the final decision in approximately three months. Caelyx is a pegylated liposomal formulation of doxorubicin marketed under the name Doxil in the U.S.
¿ Aviron, of Mountain View, Calif., started Phase I testing of its vaccine candidates to prevent infection with cytomegalovirus, the leading infectious cause of birth defects in the U.S. The study will evaluate the safety of four live attenuated injectable vaccine candidates.
¿ Cel-Sci Corp., of Vienna, Va., said data was presented showing Multikine was safe at the doses tested when given to HIV-infected patients. The key finding was after the eight-week treatment, the physicians observed in both dose groups statistically significant (p<0.01) increased ability to respond to skin tests for several recall antigens, such as Tetanus toxoid and Candida antigen. Multikine is a mixture of cytokines. It is in several Phase II trials against head and neck cancer. The findings were presented at the 1st International Conference on Vaccine Development and Immunotherapy in HIV in Palm Beach, Fla.
¿ Diversa Corp., of San Diego, and The Dow Chemical Co., of Midland, Mich., formed a joint venture company to develop and commercialize products for the industrial enzyme market. Diversa will discover and evolve novel enzymes, and Dow will optimize strains, and will handle expression, product development and manufacturing. Diversa will receive exclusivity fees, technology development fees and research and development payments. Diversa is contributing several product candidates that the joint venture expects to commercialize in the next 18 to 36 months.
¿ Emisphere Technologies Inc., of Tarrytown, N.J., and DuPont Pharmaceuticals Co., of Wilmington, Del., have agreed to terms on a development and marketing agreement for oral formulations of heparin and low-molecular-weight heparin using Emisphere's proprietary drug delivery technology. The companies executed a non-binding letter of intent. They will collaborate to co-develop solid oral-dosage forms of heparin and low-molecular-weight heparin. The oral liquid formulation of heparin is in Phase III trials. Emisphere will receive up-front fees, milestones and royalties.
¿ Gene Logic Inc., of Gaithersburg, Md., and Genaissance Pharmaceuticals Inc., of New Haven, Conn., signed an agreement to share access to key gene expression and gene variation data. The data will help advance the design and development of new drugs using genomics information. Genaissance will subscribe to Gene Logic's GeneExpress Suite of databases. Gene Logic will purchase from Genaissance rights to certain gene-specific single nucleotide polymorphism data sets. Financial terms were not disclosed.
¿ Incyte Genomics Inc., of Palo Alto, Calif., and the Baylor College of Medicine, of Houston, entered a genomics research partnership with the Texas Children's Cancer Center. The entities will work to conduct gene expression studies and determine the role of genes in the prevention, diagnosis and treatment of cancers commonly affecting children. Intellectual property resulting from this collaboration will be owned jointly by Baylor and Incyte and available for licensing through Incyte. Incyte also expanded its agreement with Eli Lilly and Co., of Indianapolis, to accelerate the development of therapeutic proteins. Lilly also will obtain options to license multiple therapeutic protein patents from Incyte. Financial terms were not disclosed.
¿ Psychiatric Genomics Inc., of Rockville, Md., acquired a subscription to a portion of Gaithersburg, Md.-based Gene Logic Inc.'s GeneExpress database system focusing on central nervous system samples. PGI will use the subscription for drug discovery and development programs in CNS areas, including neurodegenerative and psychiatric disorders.
¿ Qiagen N.V., of Venlo, the Netherlands, completed its $110 million acquisition of Operon Technologies Inc., of Alameda, Calif. Operon is focused on the field of high-end and value-added synthetic DNA. Qiagen issued about 598,000 shares of stock and assumed options on Operon's common stock exercisable for another 106,000 shares of Qiagen stock.
¿ Trinity Biotech plc, of Dublin, Ireland, received FDA approval for Captia ENA Profila Elisa, which is used as an aid in the diagnosis of autoimmune diseases. The product can give diagnostic information for six different autoimmune diseases from one blood sample. The six diseases are systemic lupus erythematosus, scleroderma, dermatomyositis, Sjogren's syndrome, polymyositis and mixed connective tissue disease.
¿ Vertex Pharmaceuticals Inc., of Cambridge, Mass., and marketing partner Glaxo Wellcome plc, of London, are one step closer to European approval of the HIV protease inhibitor Agenerase (amprenavir). The Committee for Proprietary Medicinal Products recommended the European Commission approve the product for marketing in the 15 member states of the European Union. Agenerase already is approved in the U.S., Japan and several other countries.