¿ Alza Corp., of Palo Alto, Calif., said the FDA has accepted for priority review a supplemental new drug application for Doxil (liposomal doxorubicin) to treat refractory ovarian cancer, an indication for which it has been granted orphan status. Doxil already is indicated for treatment of certain Kaposi¿s sarcoma patients.
¿ Calypte Biomedical Corp., of Alameda, Calif., closed on a financing involving the sale of 3.4 million shares, netting $7 million. Pacific Growth Equities Inc., of San Francisco, was the placement agent.
¿ Celgene Corp., of Warren, N.J., received orphan designation for its lead compound, Thalomid (thalidomide), for the treatment of Crohn¿s disease. The product is in Phase II testing in that indication.
¿ Encore Pharmaceuticals Inc., of Loma Linda, Calif., dosed the first patient in a Phase II trial of its lead compound, E-7869, in advanced or hormone-refractory prostate cancer. The 36-patient study is expected to be completed within one year.
¿ GelTex Pharmaceuticals Inc., of Waltham, Mass., said results from two Phase II studies of Cholestagel confirmed earlier results showing the drug, in combination with statins, resulted in statistically significant reductions in LDL cholesterol when compared to either drug by itself. The company plans to complete its analysis and present data at a scientific meeting later this year. Also, the company said it remains on target for filing a new drug application by mid-year.
¿ Genelabs Technologies Inc., of Redwood City, Calif., and SmithKline Beecham plc, of London, are collaborating to develop a system for regulating expression of genes needed for survival or replication of certain bacteria. The collaboration is being funded by a one-year grant from the Defense Advanced Research Projects Agency.
¿ Genzyme Transgenics Corp., of Framingham, Mass., and Invitrogen Corp., of Carlsbad, Calif., launched their pBC1 Milk Expression Vector Kit, which allows for the production of recombinant proteins in the milk of transgenic mice.
¿ ICN Pharmaceuticals Inc., of Costa Mesa, Calif., completed a previously authorized $10 million stock buyback. It bought 200,000 shares for $4.5 million in the fourth quarter of 1998 and 223,967 shares for $5.5 million in the first quarter of this year.
¿ Inhibitex Inc., of Alpharetta, Ga., signed an exclusive licensing and research agreement with BioResearch Ireland, the national agency commercializing biotechnology from Irish universities and research institutions. The focus of the deal is discovery and characterization of cell-surface adhesins from Staphylococcus aureus and coagulase-negative staphylococci. The research will be conducted at BioResearch Ireland¿s National Pharmaceutical Biotechnology Centre at Trinity College, in Dublin, and at the Moyne Institute of Preventive Medicine. Adhesins discovered through the collaboration will be used by Inhibitex to develop immunotherapeutics targeting hospital-acquired, antibiotic-resistant staph infections.
¿ Kinetix Pharmaceuticals Inc., of Medford, Mass., completed an $8.8 million series B private financing to advance its kinase inhibitor discovery programs. Investors included Schroder Ventures International Life Sciences Fund; JAFCO Co. Ltd.; Lombard-Odier Immunology Fund; Zero Stage Capital; and The Novartis Venture Fund.
¿ Kosan Biosciences Inc., of Hayward, Calif., received an undisclosed Phase I small business technology transfer research grant from the National Institutes of Health to research novel analogues of rapamycin and FK506 for nerve regeneration.
¿ PathoGenesis Corp., of Seattle, said its London subsidiary began enrolling patients in an open-label randomized trial of TOBI (tobramycin for inhalation) at 14 cystic fibrosis centers in the U.K. and Ireland. While not required for approval in Europe, the trial is intended to give clinicians hands-on experience with the drug.
¿ SciClone Pharmaceuticals Inc., of San Mateo, Calif., entered into an agreement with Italy-based Sigma-Tau S.p.A. that gives Sigma-Tau semi-exclusive rights to market Zadaxin (thymosin alpha 1) in Italy and Spain, and exclusive rights in Switzerland.
¿ Sugen Inc., of Redwood City, Calif., said it dosed the first patient with an oral formulation of SU6668, a tyrosine kinase inhibitor that has antitumor and anti-angiogenesis properties. The trial is being conducted in patients with advanced cancers who have failed other treatment options.
¿ Telik Inc., of South San Francisco, and Sankyo Co. Ltd., of Tokyo, established a collaboration that will use Telik¿s TRAP chemoinformatics technology to screen its small-molecule library for compounds against up to 10 Sankyo targets. Sankyo will make an undisclosed up-front payment and have an option to acquire a license to develop identified molecules. It is Telik¿s fifth deal with a Japanese company, and third this year.
¿ Trimeris Inc., of Durham, N.C., filed an investigational new drug application to begin clinical trials of T-1249, a synthetic peptide that blocks fusion of HIV with host cells. The Phase I study, expected to begin this quarter, will be conducted in up to 60 patients and involve different doses and while assessing antiviral activity as well as safety.
¿ Zonagen Inc., of The Woodlands, Texas, said a U.S. District Court in Texas dismissed with prejudice class action lawsuits consolidated in May 1998 against the company. Lawsuits alleged the company made false and misleading statements relating to patents on Vasomax and ImmuMax, and trials of Vasomax. The court ruled the suits failed to state a claim under federal securities laws.