• Basilea Pharmaceutica Ltd., of Basel, Switzerland, said a new drug application for ceftobiprole was submitted to the FDA by partner Johnson & Johnson Pharmaceutical Research and Development LLC, of New Brunswick, N.J., for the treatment of complicated skin and skin structure infections, including diabetic foot infections. The filing triggered a CHF24 million (US$19.6 million) milestone payment from a J&J subsidiary. Ceftobiprole is an anti-MRSA broad-spectrum cephalosporin antibiotic. The NDA was based on data from two Phase III trials involving 1,600 patients with Gram-negative and Gram-positive pathogens and with methicillin-resistant Staphylococcus aureus infections. In those studies, ceftobiprole was effective, achieving non-inferiority endpoints to either single drug or two-drug combination comparators. Ceftobiprole also is in development in hospital-acquired pneumonia and is in Phase III testing in that indication.
• Durect Corp., of Cupertino, Calif., said Voyager Pharmaceutical Inc., of Raleigh, N.C., has reported that the truncated Phase III trial with Memryte for Alzheimer's disease turned up positive outcome trends among women, but no positive effect among men. Durect, which has a development and commercialization deal with Voyager, has not independently verified the analysis performed or conclusions. Based on those results, however, Voyager intends to focus its efforts on developing Memryte for the treatment of Alzheimer's disease in women and on seeking a potential partner for the program.
• Fluxion Biosciences Inc., of San Francisco, received a $1.2 million National Institutes of Health grant for the development of a multiplexed single-cell electroporation system. The Phase II SBIR grant continues the development funded by NIH as part of a Phase I project completed last year.
• Inverness Medical Innovations Inc., of Waltham, Mass., and Biosite Inc., of San Diego, reached an agreement to merge the two companies. Inverness will acquire all of Biosite's outstanding common stock not already owned by Inverness for $92.50 per share. Ahead of the deal, Biosite terminated merger plans with Beckman Coulter Inc., of Fullerton, Calif., which had offered to buy Biosite for $90 per share. Beckman gets a $54 million breakup fee from Biosite. (See BioWorld Today, April 11, 2007.)
• Molecular Insight Pharmaceuticals Inc., of Cambridge, Mass., entered a purchase agreement to buy a commercial-scale radiopharmaceutical manufacturing facility located in Denton, Texas. Molecular Insight is acquiring the facility from NeoRx Manufacturing Group Inc., a wholly owned subsidiary of Poniard Pharmaceuticals Inc., of South San Francisco, for $3 million.
• Valentis Inc., of Burlingame, Calif., received notification from Nasdaq that its securities will be delisted from the Nasdaq Capital Market at the opening of business today. The Nasdaq delisting notice was based upon the failure of Valentis to achieve by specified dates certain milestones under its plan of compliance, as presented to a Nasdaq panel March 1.