• Acceleron Pharma Inc., of Cambridge, Mass., said it was selected to receive a Biotech Investment Award from the Multiple Myeloma Research Foundation to support the research and development of ACE-011, a bone-forming agent, for the treatment of multiple myeloma. In addition, Acceleron said it began a randomized, double-blind, placebo-controlled multiple ascending dose study of ACE-011. The multiple dose study will be conducted in healthy, postmenopausal women. Subjects will receive four monthly subcutaneous doses of either ACE-011 or placebo. The primary objective of the study is to assess the safety, tolerability and pharmacokinetics of ACE-011. The pharmacodynamic effects of ACE-011 on bone also will be measured.

• BioMS Medical Corp., of Edmonton, Alberta, said the Federal Trade Commission has cleared the global licensing and development agreement granting Indianapolis-based Eli Lilly and Co. exclusive worldwide rights to BioMS Medical's lead multiple sclerosis compound, MBP8298. The clearance means the transaction may proceed. Under the terms of the agreement, Lilly and BioMS will collaborate on the development of MBP8298 and also will share in certain development costs, with Lilly being responsible for future R&D, manufacturing and marketing activities. BioMS will receive an up-front payment of $87 million, as well as potential development and sales milestones up to $410 million and escalating royalties on sales commensurate with the current stage of development of the product if MBP8298 is commercialized successfully. (See BioWorld Today, Dec. 19, 2007.)

• EpiCept Corp., of Tarrytown, N.Y., said its marketing authorization application for Ceplene in the European Union has advanced to the next step. The company has submitted written responses to the Committee for Human Medicinal Products addressing outstanding issues related to the application. The next regulatory milestone will be an oral explanation before all member states reviewing the application. EpiCept also said it expects to unblind and announce the results from its Phase II Neuracept trial for EpiCept NP-1 cream in patients suffering from diabetic peripheral neuropathy in the near future.

• ImmuneRegen BioSciences, of Scottsdale, Ariz., a wholly owned subsidiary of IR BioSciences Holdings Inc. has finalized a material transfer agreement with Celgene Cellular Therapeutics, of Summit, N.J., under which ImmuneRegen will ship its potential therapeutic Homspera to CCT for testing. CCT will explore Homspera's impact when used in conjunction with CCT's human stem/progenitor cell active products and developmental candidates. ImmuneRegen and Celgene also agreed to explore other opportunities, which may lead to complementary product development pipelines.

• Interleukin Genetics Inc., of Waltham, Mass., has appointed Lewis H. Bender as chief executive officer. The company said it expects to add Bender to its board of directors. Thomas R. Curran Jr., who served as interim CEO since July 2007, will continue to serve as a member of the board. Previously, Bender was chief technology officer and interim CEO of Emisphere Technologies Inc.

• NovaDel Pharma Inc., of Flemington, N.J., said the FDA has accepted for filing its new drug application for ZolpiMist (zolpidem tartrate) Oral Spray for the short-term treatment of insomnia. The company expects the FDA will complete its review by the end of the year. The results of two previous clinical trials demonstrated bioequivalence between ZolpiMist and Ambien. Also included in the submission were data from process validation and registration stability batches produced at the intended commercial manufacturing facility.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said Nasdaq has provided the firm with an additional 180-calendar-day extension period, or until July 21, to regain compliance with the $1 minimum bid price rule. The letter states that, though Peregrine has not yet regained compliance with that rule, it has met all other initial inclusion criteria. Company shares (NASDAQ:PPHM) gained 1 cent Wednesday to close at 37 cents.

• Polydex Pharmaceuticals Ltd., of Toronto, was notified by Nasdaq that the company's bid price per share for its common stock had closed below the $1 minimum bid price for 30 consecutive business days. The company has until July 14 to correct the deficiency.

• ProMetic Life Sciences Inc., of Montreal, said its Cambridge, UK-based subsidiary ProMetic BioSciences Ltd, successfully completed the first phases of development using Edingburgh, Scotland-based Pathogen Removal and Diagnostic Technologies Inc.'s ligand technology for prion binding and removal from a plasma product for biopharmaceutical use marketed by a major European plasma fractionator. The program is expected to complete the scale-up phase in June, and is worth approximately $1 million to ProMetic. That will be followed by a multimillion dollar long-term supply agreement for the prion reduction resin, the company said.

• SciGen Ltd., of Sydney, Australia, said it has been awarded the GMP certification for its manufacturing facility in Rehovot, Israel where its third-generation hepatitis B vaccine Sci B Vac is manufactured. GMP certification is a prerequisite for the renewal of health registration in those countries where Sci B Vac previously was registered prior to the change of manufacturing site and the start of health regulatory submissions in all parts of the world including the EMEA in Europe, the FDA in the U.S. and other major health regulatory agencies.

• Sinovac Biotech Ltd., of Beijing, has entered into a securities purchase agreement with an unnamed institutional investor for a private placement of 2.5 million shares of its common stock to an institutional investor, which will raise about $9.75 million in gross proceeds. The shares were priced at $3.90 each, the last closing price prior to signing of the agreement. Sinovac specializes in developing vaccines against infectious diseases, and has products in hepatitis A and B, influenza, and is developing vaccines against the H5N1 strain of pandemic influenza and Japanese encephalitis.