• Acceleron Pharma Inc., of Cambridge, Mass, named John Knopf CEO. Knopf, a founder of the company, recently served as Acceleron's president and was the firm's executive vice president of corporate development. Before helping to form the company, Knopf headed the Cambridge research site for Madison, N.J.-based Wyeth Pharmaceuticals.

• ActiveSight, a San Diego-based division of Rigaku Americas Corp., said it will collaborate on a fragment-based lead discovery project with CHDI Inc., a Los Angeles-based nonprofit organization. Using a Huntington disease target chosen by CHDI, ActiveSight will screen fragment libraries using X-ray crystallography to visualize fragments that bind to the target. The fragments will then be linked or grown into larger, drug-like compounds. Terms of the deal were not disclosed.

The Agency for Healthcare Research and Quality (AHRQ) and the FDA are collaborating to study medications used to treat attention-deficit/hyperactivity disorder and the potential for increased risk of heart attack, stroke or other cardiovascular problems. The agencies will examine the clinical data of about 500,000 children and adults who have taken ADHD drugs to determine whether those drugs increase cardiovascular risks. The analysis will take about two years to complete. In May 2006, the FDA asked drug manufacturers to revise product labeling to reflect concerns about adverse cardiovascular and psychiatric events.

• Amura Holdings Ltd., of Cambridge, UK, said preclinical study results showed that oral administration of the firm's cathepsin K inhibitor compounds resulted in sustained and potent reduction of serum bone turnover biomarkers, which clinically correlates with a significant reduction in fracture rates. Cathepsin K, a member of a large family of cysteine peptidases, is an enzyme that breaks down the collagen bone matrix as part of a normal biological process.

• Aphios Corp., of Woburn, Mass., and collaborator Boston University Medical School were awarded a Phase I Small Business Technology Transfer Grant in an undisclosed amount from the National Cancer Institute to develop a novel, nontoxic vitamin D analogue for hormone-refractory prostate cancer.

• Artisan Pharma Inc., of Waltham, Mass., and A-Bio Pharma Pte. Ltd., of Singapore, finalized a mutually exclusive manufacturing relationship on the process development, scale-up and manufacture of ART-123, a recombinant protein for the treatment of disseminated intravascular coagulation in sepsis. A-Bio will undertake the various development and validation activities necessary to ensure further clinical development and commercial supply of ART-123 for Artisan. In return, Artisan will enter into a preferential and long-term supply agreement with A-Bio. Specific terms of the relationship were not disclosed. ART-123 is a recombinant, soluble thrombomodulin. A regulatory submission for approval of ART-123 in the treatment of DIC has been filed in Japan, while Artisan has initiated an 800-patient Phase IIb trial.

• BG Medicine Inc., of Waltham, Mass., and the Spinal Muscular Atrophy Foundation entered a collaboration to discover plasma biomarkers of drug efficacy for spinal muscular atrophy, the leading genetic cause of mortality in infants and toddlers. The project seeks to discover a clinically useful molecular biomarker, which then could be used to monitor the efficacy of potential drugs in trials. Terms were not disclosed.

• Celera Group, a Rockville, Md.-based business of Applera Corp., and collaborators published a paper describing novel variants in the TRAF1/C5 gene region that predict individual susceptibility to, and severity of, rheumatoid arthritis. The work from Celera and the Leiden University Medical Centre in the Netherlands and the Karolinska Institute in Sweden is scheduled to appear in the September 2007 edition of the Public Library of Science, and currently is available on the journal's website. Compared with noncarriers, carriers of the risk variants (about 65 percent to 70 percent of the general population) had an approximate 37 percent increased risk for developing RA.

• Eden Bioscience Corp., of Bothell, Wash., said it received a Nasdaq staff deficiency letter, notifying the company that its bid price per share had closed below the $1 minimum bid requirement for 30 consecutive trading days and that, as a result, the firm no longer meets one of the requirements for continued listing. Eden has until March 10 to regain compliance.

• Enzo Biochem Inc., of New York, reported data from preclinical studies of Enzo-D58, showing that, when administered orally, the small-molecule drug prevented alveolar bone loss in a rat periodontal model. Data stems from laboratory research as part of a drug discovery program initiated by Enzo that combines structural biology, computational screening and biological assays to screen for compounds for treating osteoporosis and other conditions resulting from bone loss. Findings were presented at the American Society of Bone Mineral Research meeting in Honolulu.

• EpiCept Corp., of Tarrytown, N.Y., said the assessment of its European Union centralized marketing authorization application for its lead oncology product Ceplene is advancing according to the anticipated regulatory timetable, following a meeting. Ceplene (histamine dihydrochloride) has demonstrated clinical benefit in the maintenance of remission for patients with acute myeloid leukemia, and EpiCept has provided data on Ceplene's effect on quality of life and on long-term follow-up of at least five years on leukemia-free survival for AML patients. EpiCept gained rights to Ceplene through its acquisition of Maxim Pharmaceuticals Inc., of San Diego.

• Genzyme Corp., of Cambridge, Mass., is expanding its flagship manufacturing facility at Allston Landing in Boston. The $150 million project is focused on adding space, including 86,000 square feet of new office and manufacturing support space and a 26,000-square-foot co-generation facility. It is expected to create about 90 jobs.

• Intra-Cellular Therapies Inc., of New York, said it has developed a novel series of nonhormonal compounds that show promise in the treatment of female sexual dysfunction. The small-molecule agents are specific and potent inhibitors designed to regulate neuronal activity in selected regions of the brain, according to the company, which believes the compounds may have utility in the treatment of hypoactive sexual desire disorder, a condition that affects a significant percentage of older, peri- and postmenopausal women and is one of the disorders commonly classified as female sexual dysfunction. The molecules have demonstrated promising activity in animal models of sexual behavior, specifically eliciting enhanced female sexual interest and activity, Intra-Cellular said.

• Medarex Inc., of Princeton, N.J., granted Oxford Genome Sciences Ltd., of Abingdon, UK, access to its fully human antibody technology in exchange for undisclosed licensing fees, milestone payments and royalties on commercial sales of any products that may result from the deal. The agreement potentially will enable OGS to accelerate development of its own pipeline of fully human antibodies in the field of cancer. OGS will license Medarex's transgenic mouse technology to generate antibody therapeutics against cancer targets that OGS identifies using its OGAP database. OGS will retain full worldwide rights to the new human antibodies generated.

• MorphoSys AG, of Martinsried, Germany, said a HuCAL Gold-derived fully human antibody against an undisclosed target molecule in the therapeutic area of oncology has been advanced to the Phase I trial stage. The investigational new drug application filing, resulting from MorphoSys' collaboration with Novartis AG, of Basel, Switzerland, triggered an undisclosed milestone payment to MorphoSys. In May 2004, Novartis and MorphoSys signed a wide-ranging strategic antibody alliance to jointly develop new antibody-based therapeutics to treat a range of illnesses, and they expanded the deal in June 2006. The collaboration is scheduled to continue through May 2011.

• Nanobac Pharmaceuticals Inc., of Tampa, Fla., signed an agreement with NASA's Johnson Space Center in Houston for research on calcifying nanoparticles and their nature and role in pathological calcification, including the detection and treatment of the pathogen. Astronauts may be more prone to an increased rate of pathological calcification while in a zero-gravity environment. The partners are interested in pathological calcium phosphate particles found in diseases such as kidney stones, prostatitis and arthritis, which all are conditions that accelerate in humans in a zero-gravity environment.

• Nektar Therapeutics Inc., of San Carlos, Calif., said it has created two new research units to drive the company's PEGylation and pulmonary research initiatives. The firm appointed Tim Riley as vice president of the PEGylation research unit and John Sisco as vice president of the pulmonary research unit. As part of the organizational change, the company said David Johnston, Nektar's former senior vice president of research and development, will leave the company to pursue other interests.

• OSI Pharmaceuticals Inc., of Melville, N.Y., received a notice of final determination from the U.S. Patent and Trademark Office that the patent for Tarceva (erlotinib), U.S. Patent No. 5,747,498, covering composition of matter, processes for its preparation, methods of treating cancer and pharmaceutical compositions containing Tarceva, has been extended through Nov. 8, 2018. OSI also has a crystalline polymorph patent (U.S. Patent No. 6,900,221) for Tarceva that expires in 2020. Tarceva was approved by the FDA in November 2004 for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of at least one chemotherapy regimen.

• Point Therapeutics Inc., of Wellesley, Mass., received a staff determination letter from Nasdaq, notifying the company that trading of Point's common stock on the Nasdaq capital market will be suspended at the opening of business Friday, unless the company requests an appeal of the determination. The company intends to appeal Nasdaq's determination.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., is partnering with the University of Maryland in Baltimore and the state of Maryland, through the Maryland Industrial Partnerships program, to develop a pharmaceutical product specifically aimed at preventing reperfusion injury associated with cardiac ischemia. The state is contributing $100,000 of the $232,000 per year to the project at UMB, with an agreement to provide second-year funding upon successful completion of the first year's goals. RegeneRx is contributing about $54,000 to the project and retains the right to exclusively license all intellectual property emerging from the partnership.

• Senesco Technologies Inc., of New Brunswick, N.J., granted Bayer CropScience AG, of Monheim, Germany, exclusive worldwide rights to the firm's proprietary gene technology for use in rice. The agreement anticipates that the licensed technology will enable Bayer to significantly enhance seed yields. In return, Senesco is entitled to development milestone payments and royalties on resulting sales. Specific financial terms of the deal were not disclosed.

• Vion Pharmaceuticals Inc., of New Haven, Conn., said it has been notified by Nasdaq that the firm is not in compliance with the 30-day bid price rule for continued listing because its shares had closed below the required minimum bid price of $1 per share. Vion said it has until March 17 to demonstrate compliance with the rule.

No Comments