o AltaRex Corp., of Waltham, Mass., submitted an investigational new drug amendment to the FDA that would allow it to conduct a second potentially pivotal Phase IIb trial of OvaRex Mab, for late-stage ovarian cancer patients. The new Phase IIb study will be randomized, double-blind and placebo-controlled, and will test the safety and efficacy of OvaRex Mab in ovarian cancer patients with an elevated serum CA 125 who have completed first line treatment and have no other evidence of disease.
o American Home Products Corp., of Madison, N.J., said its Wyeth-Ayerst Pharmaceuticals division submitted a marketing authorization application to the European Medicines Evaluation Agency for Enbrel (etanercept), for the treatment of active rheumatoid arthritis. Immunex Corp., of Seattle, recently won FDA approval for the drug. (See BioWorld Today, Nov. 3, 1998, p. 1.)
o Alza Corp., of Palo Alto, Calif., acquired exclusive marketing and distribution rights to Urispas (flavoxate hydrochloride) in the U.S. from SmithKline Beecham plc., of London. Alza will make an undisclosed up-front payment and may make additional milestone payments, while SmithKline will manufacture the product for Alza. Urispas, a smooth muscle relaxant that counteracts muscle spasms in the urinary tract, is used to relieve symptoms associated with urinary incontinence and painful urination.
o Calypte Biomedical Corp., of Berkeley, Calif., signed a purchase agreement to sell 3,102,500 shares of its common stock to institutional investors in a private placement. The net proceeds to the company are estimated at about $2.8 million.
o Dura Pharmaceuticals Inc., of San Diego, and Spiros Development Corp. Inc., of San Diego, received word from the FDA that the new drug application (NDA) for Albuterol Spiros is not approvable until certain deficiencies are addressed. The FDA wants additional trials on the Spiros inhaler in order to ensure inhaler reliability and replicate the clinical outcomes of the initial trials. It also wants to resolve a number of chemistry, manufacturing and control issues. The company plans to meet with the FDA later this month.