• Acorda Therapeutics Inc., of Hawthorne, N.Y., has acquired two key licensing and research agreements in a stock deal with Neurorecovery Inc., of Memphis, Tenn. The licenses relate to the use of aminopyridines in peripheral neuropathies and to two early stage development candidates. Acorda also acquired Neurorecovery's preclinical and clinical data, regulatory filings (including orphan drug designations), copyrights, trademarks and domain names relating to the three products. Two Phase II studies of the aminopyridine compound Ampydin for the treatment of chronic functional motor and sensory deficits resulting from Guillain-Barre syndrome have been completed. Acorda issued 100,000 shares of its common stock as the purchase price. The transaction will be accounted for as an acquisition of in-process research and development assets and, as such, will result in a noncash expense in the first quarter of approximately $2.7 million.
• BioMarck Pharmaceuticals, of Research Triangle Park, N.C., has obtained FDA approval for its plans for a Phase II trial of the respiratory drug, BIO-11006 Inhalation Solution. Phase I studies of BIO-11006, an inhaled drug designed to combat the oversecretion of mucus and inflammation in diseases such as chronic obstructive pulmonary disease (COPD), asthma and cystic fibrosis were conducted on healthy volunteers and demonstrated that the treatment is safe and well tolerated. BioMarck's Phase II clinical trial will be a multicenter, placebo-controlled, double-blind trial involving approximately 160 COPD patients. The primary objective of the study is to demonstrate that BIO-11006 treatment improves lung function in COPD patients.
• CellCyte Genetics Corp., of Kirland, Wash., has been sued by a group of shareholders alleging that the company misled investors by publishing false information about the history and experience of company CEO Gary A. Reys. A similar lawsuit was filed last month by Hagens Berman Sobol Shapiro LLP.
• Karo Bio, of Stockholm, Sweden, and Zylus Cadila, of Ahmedabad, India, have entered into a three-year collaboration to develop new drugs for the treatment of inflammatory diseases. The goal is selective glucocorticoid receptor modulators for conditions such as rheumatoid arthritis, bowel disorders, psoriasis and asthma. Zylus Cadila will carry out preclinical work, filing of the investigational new drug application and preclinical studies and human clinical trials. Karo will use its expertise in nuclear receptor drug discovery including structural biology, drug design and compound characterization. Financial terms were not disclosed.
• Neurogen Corp., of Branford, Conn., has appointed Stephen R. Davis president and CEO. William Koster, former CEO, has retired and remains a member of the board of directors. Since September, Davis has held the title of president.
• Oncolytics Biotech Inc., of Calgary, Alberta, reported data showing that combining reovirus and radiotherapy significantly increased cancer cell killing both in vitro and in vivo, particularly in cell lines with moderate susceptibility to reovirus alone. The data were published by the UK-based Institute of Cancer Research, London, in a paper published online in the Feb. 1, 2008, issue of Clinical Cancer Research.
• PDI Inc., of Saddle River, N.J., has signed an agreement with an unnamed pharmaceutical company for a new contract sales engagement. The deal involves PDI's Select Access Team to reach pediatricians. The fee-for-service contract is expected to generate approximately $7.5 million over its 12-month term.
• Progen Pharmaceuticals Ltd., of Brisbane, Australia, said the company has executed a definitive agreement to acquire privately held U.S. oncology company CellGate Inc., of Redwood City, Calif. The purchase price includes $1 million up front, and assumption by Progen of up to $1 million in CellGate liabilities. In addition, CellGate shareholders could receive up to $19.5 million upon the achievement of clinical and regulatory milestones. The acquisition gives Progen's several preclinical and clinical oncology compounds focused on polyamine and epigenetic targets, including CellGate's lead product candidate in Phase I and 10 preclinical compounds.
• Seaside Therapeutics, of Cambridge, Mass., has awarded a $4.5 million collaborative research contract to Vanderbilt University Medical Center to discover compounds to potentially suppress the manifestations of fragile X syndrome. Scientists at Vanderbilt have identified more than 400 novel compounds belonging to multiple chemical classes that inhibit mGluR5.
• VioQuest Pharmaceuticals, of Basking Ridge, N.J., said the FDA has granted orphan drug status to product candidate VQD-002 for the treatment of multiple myeloma. VQD-002 is a small-molecule anticancer compound that inhibits protein kinase B, a key component of a signaling pathway known to promote cancer cell growth and survival as well as resistance to chemotherapy and radiotherapy. VioQuest has reported preliminary Phase I results from ongoing studies in both solid tumors and hematological malignancies, and the company plans to advance VQD-002 into Phase II development in 2008. Orphan drug designation entitles VioQuest to seven years of marketing exclusivity upon regulatory approval. In addition, VioQuest is exploring a range of clinical research study opportunities in collaboration with the Institute for Myeloma & Bone Cancer Research in California.