• Actelion Ltd., of Allschwil, Switzerland, said its South San Francisco-based subsidiary received a subpoena from the U.S. Attorney's Office for the Northern District of California seeking documents relating to the firm's U.S. marketing and sales practices of its pulmonary arterial hypertension drug Tracleer (bosentan). The company said it intended to cooperate with the investigation.

• Amgen Inc., of Thousand Oaks, Calif., will face an FDA Cardiovascular and Renal Drugs Advisory Committee review of its Phase III TREAT study, in which Aranesp (darbepoetin alfa) failed to significantly reduce heart attacks and other cardiovascular events or delay renal replacement therapy in anemic chronic kidney disease patients with Type II diabetes. The advisory committee meeting is set for Oct. 18 and is a follow-up to the Sept. 2007 meeting on the risks and benefits of erythropoeisis-stimulating agents. (See BioWorld Today, Sept. 13, 2007, and Aug. 27, 2009.)

• Athersys Inc., of Cleveland, said preclinical results published in the October 2010 issue of Experimental Neurology demonstrated that intravenous injection of MultiStem, the firm's multipotent adult progenitor stem cell therapy, provided neurovascular protection after traumatic brain injury. MultiStem enabled the preservation of the blood-brain barrier while also reducing the effects and extent of the brain injury.

• Epistem plc, of Manchester, UK, reported preclinical results demonstrating that its therapeutic antibodies significantly reduced the symptoms of disease using a chronic adoptive T-cell transfer model of human colitis. The firm said the results will be presented next week in Chantilly, Va., at the Inflammation Research Association conference.

• Epitomics Inc., of Burlingame, Calif., plans to distribute a panel of LRRK2 monoclonal antibodies jointly developed with the Michael J. Fox Foundation for Parkinson's Research to the entire Parkinson's disease research community at a low cost to help advance therapeutic development efforts.

• Genzyme Corp., of Cambridge, Mass., gained Japanese approval of Synvisc (hylan G-F 20) for osteoarthritis of the knee and signed a Japanese commercialization deal with Teijin Pharma Ltd. Specific financial terms for the deal were not disclosed, but Osaka, Japan-based Teijin will pay Genzyme certain milestones and a predetermined supply price for Synvisc. Synvisc and single-injection version Synvisc-One are already FDA approved.

• Global Health Ventures Inc., of Vancouver, British Columbia, initiated development of a sublingual formulation of telcagepant (formerly MK-0974), an antimigraine drug originally developed by Merck & Co. Inc., of Whitehouse Station, N.J. Telcagepant blocks the clacitonin gene-related hormone receptor, a vasodilator protein believed to be a key player in migraine. Merck's Phase IIa exploratory study found that a small number of patients taking telcagepant twice daily for three months for the prevention of migraine were found to have marked elevations in liver transaminases, although the daily dosing regimen was different than the one used in Merck's Phase III studies. Global Health said a sublingual formulation would enter the blood first, reaching the site of action before entering the liver, and therefore, would be safer.

• Harbor BioSciences Inc., of San Diego, was notified by Nasdaq that it has not complied with listing rules and unless the firm appeals, trading of its common stock will be suspended and its securities will be delisted. Harbor said it does not intend to appeal the delisting determination and anticipates its stock to be suspended and delisted at the opening of business on Sept. 23.

• Myrexis Inc., of Salt Lake City, reported preclinical data demonstrating that treatment with MPC-9528 resulted in significant tumor growth inhibition. The data also showed that the co-administration of niacin improved the therapeutic index of MPC-9528. Additional data from a large panel of tumor cell lines and primary human tumor tissue indicated that about 40 percent of all cancers may carry a biochemical defect making them respond well to the combination of niacin and MPC-9528 treatment.

• OctoPlus NV, of Leiden, Netherlands, signed a feasibility agreement with an unnamed U.S.-based pharmaceutical company relating to the use of OctoPlus' controlled-release technology. Under the contract, OctoPlus will develop a controlled-release formulation of an undisclosed compound using its proprietary drug delivery technology PolyActive. If the evaluation is successful, the companies may decide to enter into a full process development, manufacturing and licensing agreement. Financial terms of the current agreement were not disclosed.

• Oxygen Biotherapeutics Inc., of Durham, N.C., amended an existing cooperative research and development agreement with the U.S. Naval Medical Research Center to include preclinical trials using swine models to assess the safety and efficacy of the company's Oxycyte perfluorocarbon emulsion for spinal cord injury due to decompression sickness and for hemorrhagic shock. The spinal cord injury trial will measure safety and efficacy of Oxycyte in conjunction with recompression therapy, while the hemorrhagic shock protocol will examine the therapy's ability to preserve systemic oxygenation in large porcine models.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., provided an update on its Defense Department contract. The two-year base period has been extended by six months to March 2011 to evaluate bavituximab in advanced models of viral hemorrhagic fever, and includes about $2.4 million in additional funding. The contract began June 30, 2008, and was originally for a five-year period. The base period now provides for up to $24.7 million in funding for a total of up to $36.3 million in funding for the duration of the contract.

• Signum Biosciences Inc., of Princeton, N.J., recently received two Small Business Innovation Research (SBIR) Phase I grants by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, part of the National Institutes of Health, totaling more than $684,000 for development of G-protein coupled receptor modulating therapeutics designed to treat common skin disorders. Through the first SBIR grant, Signum will develop anti-inflammatory agents to reduce chronic redness (erythema) associated with eczema, atopic dermatitis and rosacea. A second SBIR grant was awarded to fund Signum's identification and development of multifunctional, safe, topical anti-acne therapeutics.