Alkermes Inc., of Cambridge, Mass., said partner Johnson & Johnson Pharmaceutical Research & Development, a unit of Johnson & Johnson, of New Brunswick, N.J., received approval to market Risperdal Consta (risperidone) in the UK, which followed the recent approval in Germany. Alkermes said the product, which is in late-stage regulatory review in number of other countries, would be launched in both countries this week. Alkermes' stock (NASDAQ:ALKS) gained $1.51 Friday, or 24.4 percent, to close at $7.70.
British Biotech plc, of Oxford, UK, entered an agreement for a broad-based collaboration with GeneSoft Inc., of South San Francisco, to discover and develop anti-infective drugs based on British Biotech's bacterial metalloenzyme inhibitors. GeneSoft will make an up-front payment of $4 million, and after beginning a Phase I study of BB-83698, expected in October, GeneSoft will pay $1 million as well as equity worth 3.45 percent of GeneSoft.
Columbia Laboratories Inc., of Livingston, N.J., submitted to the FDA a new drug application for its testosterone buccal bioadhesive product, a controlled- and sustained-release product containing 30 mg of testosterone. Data from a 98-patient U.S. Phase III trial showed the product's ability to deliver mean testosterone blood levels of 5.3 ng/ml (normal physiologic range is 3.0 to 10.5 ng/ml) for all patients, while 85 percent had a mean testosterone concentration over 24 hours within the physiologic range. In a European trial, 85 percent of those taking the product showed testosterone concentrations within the physiologic range, vs. 58 percent for a group using a competing product.
Ganeden Biotech Inc., of Prince William County, Va., received a Department of Defense award titled "Topical Strategy for the Prevention and Treatment of Fungal Infections in U.S. Marine Corps Personnel." Preliminary studies will be conducted to determine the safety and efficacy of Ganeden's topical antifungal lotion. Animal and human safety studies will employ a four-arm approach, with the animal phase beginning immediately.
ICOS Corp., of Bothell, Wash., adopted a stockholders rights plan and declared a dividend distribution of one preferred share purchase right on each outstanding share of its common stock. The rights will be exercisable if an entity acquires 15 percent or more of its outstanding common stock or intends to acquire 15 percent or more. The company said the plan is not being adopted in response to any specific acquisition effort.