• Ascenta Therapeutics Inc., of Malvern, Pa., said the Leukemia and Lymphoma Society will support clinical development of AT-406, a small-molecule IAP inhibitor for acute myeloid leukemia. A Phase I trial is slated to begin next year.
• Champions Biotechnology Inc., of Baltimore, signed a partnership with Jerusalem-based Teva Pharmaceutical Industries Ltd. Champions will use its Tumorgraft platform to evaluate an anti-angiogenic drug from Teva. Terms were not disclosed.
• Cubist Pharmaceuticals Inc., of Lexington, Mass., filed a citizen petition with the FDA, urging the agency to refrain from approving any abbreviated new drug applications for generic versions of Cubicin (daptomycin) until applicants have demonstrated the comparability of their products to Cubicin using appropriate microbiological potency, chemical and in vivo testing; monitored and controlled for impurities that may be present in their daptomycin products, which may not be detectable using conventional methods; and have demonstrated the compatibility of their products with commonly used infusion systems and plastic syringes to prevent leaching of potentially dangerous extractables, including 2-mercaptobenzothiazole.
• GenVec Inc., of Gaithersburg, Md., reported preclinical data with a vaccine using the company's technology, which showed sustained production of neutralizing antibodies and a lack of immunological responses associated with adverse events linked to prior vaccine approaches for respiratory syncytial virus. Data were presented at the Respiratory Syncytial Virus Symposium in Rotterdam, the Netherlands.
• GTC Biotherapeutics Inc., of Framingham, Mass., completed its sale of about 61.1 million shares of common stock to LFB Biotechnologies SAS, of Les Ulis, France, in a private placement for 30 cents per share, or about $18.3 million. Following the private placement and conversion of preferred stock, LFB owned at least 90 percent of GTC outstanding stock. GTC agreed in November to go private via a stock purchase and merger agreement with long-time partner LFB. (See BioWorld Today, Nov. 9, 2010.)
• Gruenenthal GmbH, of Aachen, Germany, licensed the Phase II small-molecule analgesic GRT 6005 and follow-on compound GRT 6006 to Forest Laboratories Inc., of New York. Forest will pay an up-front fee, milestones and royalties in exchange for U.S. and Canadian rights and a co-promotion option in Europe. Specific terms were not disclosed.
• Human Genome Sciences Inc., of Rockville, Md., and its partner GlaxoSmithKline plc, of London, reported that the FDA extended the PDUFA date for priority review of the biologics license application for Benlysta (belimumab) as a potential treatment for systemic lupus erythematosus from Dec. 9, 2010, to March 10, 2011. After the FDA's Arthritis Advisory Committee met on Nov. 16 to consider Benlysta's BLA, during which panelists voted 13 to 2 in favor of approval, regulators requested some additional information from HGSI, which the firm said has been submitted. Monness Crespi Hardt analyst Avik Roy noted Wall Street already had anticipated the potential for a delay in Benlysta's approval. (See BioWorld Today, Nov. 17, 2010.)
• Merrion Pharmaceuticals plc, of Dublin, Ireland, signed a deal with an undisclosed pharmaceutical company to evaluate whether Merrion's GIPET drug delivery technology can boost the bioavailability of three of the pharma's drugs. Following the feasibility study, the pharma will have an option to license the technology. Terms were not disclosed.
• NeuroVive Pharmaceutical AB, of Lund, Sweden, was granted orphan drug designation by the FDA for NeuroSTAT (cyclosporine), a cremophor- and ethanol-free intravenous cyclosporine product, as a treatment for moderate to severe traumatic brain injury.
• Nile Therapeutics Inc., of San Mateo, Calif., was notified by Nasdaq that its stock would be delisted for failing to meet the $1 minimum bid price rule. The company intends to request a hearing, which will stay any action until the panel renders a decision.
• NovaBay Pharmaceuticals Inc., of Emeryville, Calif., and Galderma SA, of Lausanne, Switzerland, expanded their multiyear collaboration agreement initially formed in March 2009, under which Galderma agreed to exercise its option to advance the clinical development program for Aganocide compounds against impetigo and will pay a $3.25 million continuation fee together with additional R&D funding in 2010 and 2011. NovaBay has the potential to receive up to $62 million in milestones from Galderma, as well as escalating double-digit royalties on net sales of products once commercialized. Galderma will be financially responsible for all the development and clinical costs and will reimburse NovaBay for the costs incurred in support of the collaboration. NovaBay retains the right to co-market products resulting from the agreement in Japan. In addition, NovaBay has retained rights in certain Asian markets outside of Japan, and has exclusive rights to promote the products developed under the agreement in hospital and other health care institutions in North America. (See BioWorld Today, March 26, 2009.)
• PolyTherics Ltd., of London, is collaborating with MacroGenics Inc., of Rockville, Md., to apply PolyTherics' site-specific pegylation technologies to an initial dual-affinity re-targeting (DART) protein for evaluation by MacroGenics. Under the terms, MacroGenics has the option to use PolyTherics' technologies for additional DART candidates in the future and holds an option to license use of the technologies for further development and commercialization activities. Financial terms were not disclosed.
• Sangart Inc., of San Diego, entered a Cooperative Research and Development Agreement with the U.S. Navy to develop MP4 in traumatic brain injury. MP4 is a pegylated hemoglobin molecule designed to enhance oxygen delivery to the capillaries and target tissues.
• SuppreMol GmbH, of Martinsried, Germany, was awarded €1.6 million (US$2.12 million) by the German Federal Ministry of Education and Research to support a research project to explore the therapeutic potential of the company's lead candidate SM101, a recombinant, soluble, nonglycosylated version of the Fc gamma receptor IIb, in patients with systemic lupus erythematosus, particularly lupus nephritis, as well as a project to evaluate the drug in animal models for the treatment of chronic obstructive pulmonary disease.