• Acusphere Inc., of Watertown, Mass., said its product candidate, AI-850, has a comparable pharmacokinetic profile to the breast cancer drug Abraxane, marketed by Los Angeles-based Abraxis Bioscience Inc. and London-based AstraZeneca plc, based on human data available in publications on each drug. That means AI-850, which is Acusphere's formulation of paclitaxel, might be eligible for regulatory approval as a bioequivalent, with an accelerated development timeline. Acusphere said it plans to make changes in the formulation to make it a "more suitable commercial formulation" and will seek a partner to help bring the drug to market.

• BioMarin Pharmaceutical Inc., of Novato, Calif., said the FDA delayed the action date on the new drug application for its phenylketonuria drug, Kuvan, by about three weeks, citing an unanticipated staffing constraint at the agency. The delay is not due to any issues identified in the NDA. The new PDUFA date is Dec. 14, 2007. BioMarin filed for regulatory approval in May for Kuvan (sapropterin dihydrochloride) and intends to market the product on its own in the U.S. The company is partnered with Geneva-based Merck Serono for European commercialization. (See BioWorld Today, May 25, 2007.)

• Crucell NV, of Leiden, the Netherlands, said DSM Biologics, a business unit of Crucell and DSM Pharmaceutical Products, signed a nonexclusive PER.C6 technology research licensing agreement with Brazilian-based Recepta Biopharma SA. That deal allows Recepta to use the technology to develop four antibodies it in-licensed from the Ludwig Institute for Cancer Research. Financial terms were not disclosed.

• NexMed Inc., of East Windsor, N.J., granted Fajardo, Puerto Rico-based Warner Chilcott Co. Inc., a subsidiary of Warner Chilcott Ltd., exclusive U.S. rights to its topically applied alprostadil cream for erectile dysfunction. NexMed submitted a new drug application for the product in September. Under the agreement, NexMed received an up-front payment and is eligible for additional milestone and royalty payments. Specific financial terms were not disclosed.

• Osmetech plc, of London, licensed exclusive rights to a new warfarin biomarker discovered at the Marshfield Clinic in Marshfield, Wis., which it will use to develop and market a genetic test that will more accurately determine the initial level of warfarin, an anticoagulant, that should be prescribed to individual patients. Financial terms were not disclosed.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., said the FDA extended the PDUFA date for rilonacept (IL-Trap) in cryopyrin-associated periodic syndromes (CAPS) by three months, from Nov. 29 to Feb. 29, 2008. The agency needed more time to review the company's Oct. 26 amendment to the June biologics license application, including supplemental chemistry, manufacturing and controls information requested by the agency. Rilonacept is a long-acting agent designed to inhibit interleukin-1. (See BioWorld Today, June 11, 2007.)

• ThromboGenics NV, of Leuven, Belgium, and co-development partner BioInvent International, of Lund, Sweden, said data published in Cell showed that antibodies against PIGF (placental growth factor) can inhibit both cancer tumor growth and the development of metastases in preclinical models, without affecting healthy tissues. The companies plan to advance their lead anti-PIGF monoclonal antibody, TB-403, into the clinic by the end of 2007.