• Endo Pharmaceuticals Holdings Inc., of Chadds Ford, Pa., and Vernalis plc, of Winnersh, UK, said the FDA is requiring an additional three months to review Endo's supplemental new drug application for Frova (frovatriptan succinate) 2.5 mg tablets for the expanded indication of short-term prevention of menstrual migraine. The agency now anticipates completing its review of this application on or before Aug. 19. The original PDUFA date was May 19. The companies said the request relates to the presentation of the data, rather than content, and that no additional data have been requested.
• Exelixis Inc., of South San Francisco, submitted an investigational new drug application for cancer compound XL147, an oral small-molecule phosphoinositide-3 kinase inhibitor. In preclinical studies, the drug slowed tumor growth or caused tumor shrinkage in multiple models, including breast, lung, ovarian and prostate cancers, and gliomas. It also demonstrated an ability to enhance the antitumor effects of several chemotherapeutic agents and an inhibitor of epidermal growth factor receptor in preclinical models.
• MedImmune Inc., of Gaithersburg, Md., agreed to lease a portion of Human Genome Sciences Inc.'s facility in Rockville, Md., for the development and manufacturing of clinical trial material for cell culture-based seasonal and pandemic influenza vaccine. Financial terms were not disclosed, but MedImmune said the expanded capability will support its commitment to pandemic influenza vaccine development per a five-year, $170 million contract awarded last year by the Department of Health and Human Services.
• Neuralstem Inc., of Rockville, Md., raised $5.1 million in a private placement of 2.1 million units priced at $2.50 each to institutional investors. Each unit consists of one share of common stock and one-half warrant exercisable at $3 per share. The company plans to use proceeds for its anticipated clinical trials in ischemic spastic paraplegia, as well as for working capital and other general corporate purposes. Neuralstem's technology is designed to produce neural stem cells of the human brain and spinal cord, and the company expects to submit its first investigational new drug application this year. T.R. Winston and Co. acted as the placement agent.
• Oncolytics Biotech Inc., of Calgary, Alberta, said results of a preclinical study of its reovirus for melanoma showed that it effectively replicated in and killed a range of human melanomas in vitro. Intratumoral injection of the reovirus also significantly delayed tumor growth in a mouse implanted with a human melanoma tumor. In addition, the melanoma cell death caused by reovirus also triggered an immune response leading to additional antitumor activity. Data were presented at the International Conference on Oncolytic Viruses as Cancer Therapeutics in Carefree, Ariz.
• Titan Pharmaceuticals Inc., of South San Francisco, received a commitment of up to $25 million in common stock equity financing from Azimuth Opportunity Ltd., which may be drawn down, from time to time at Titan's discretion, over the next 24 months in exchange for common stock. Proceeds will be used for product development activities, as well as for general corporate purposes. The company entered that agreement shortly after terminating a September 2005 equity line of credit agreement with Cornell Capital Partners LLC. Under that deal, Titan drew down a total of $4 million, of a potential $35 million, but had not drawn down any funds within the last 12 months.
