Biovail Initiates Buspirone Clinical Trials.Business Editors, Health/Medical Writers TORONTO--(BW HealthWire)--Feb. 4, 2000 Biovail Corporation International (NYSE NYSE See: New York Stock Exchange :BVF BVF Biovail Corporation (stock symbol) BVF Berufsverband der Frauenärzte eV (Muenchen, Germany) BVF Bearing Versus Frequency )(TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). :BVF) announced today that as a result of a successful Phase II clinical program with respect to the company's once daily controlled release formulation of Buspirone, Phase III clinical trials have been initiated. Buspirone is currently marketed in the United States by Bristol Myers Squibb and is only available in an immediate release, three times per day dosage format. Buspirone is indicated for the treatment of generalized anxiety disorders (GAD Gad, in the Bible, son of Jacob and Zilpah and eponymous founder of one of the 12 tribes of Israel. Its allotment was half of Gilead; this was the land best suited to the pastoral life, which Gad, like Reuben, continued after the years in Egypt. ). Completion of the Phase III clinical trials is expected this year, allowing for an anticipated New Drug Application filing with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. by late 2000 to early 2001. Biovail also stated that it is in late stage development of three additional novel once daily controlled release formulations in the therapeutic classes of diabetes, pain management and anxiety disorders Anxiety disorders A group of distinct psychiatric disorders characterized by marked emotional distress and social impairment, including generalized anxiety disorder, panic disorder, obsessive-compulsive disorder, and posttraumatic stress disorder. . The Company anticipates the initiation of Phase III clinical trials over the next 12-18 months. Biovail also announced the appointment of Dr. David Tierney, M.D. as President of Biovail Technologies Ltd. Dr. Tierney will have operational responsibility for all of Biovail's research and development, regulatory and clinical activities and will be based in Chantilly, Virginia. Dr. Tierney was previously Senior Vice President, Drug Development for Roberts Pharmaceutical Corporation with overall responsibility for drug development, medical affairs, worldwide regulatory affairs and chemical process development. Prior to joining Roberts in 1997, Dr. Tierney held senior positions with Elan Pharmaceutical Research. Biovail Corporation International is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies. &uot;Safe Harbor&uot; statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA and TPP TPP thiamine pyrophosphate. Thiamine pyrophosphate (TPP) The coenzyme containing thiamine that is essential in converting glucose to energy. Mentioned in: Beriberi TPP 1. total plasma protein. 2. approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the Company's filings with the U.S. Securities and Exchange Commission. |
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