Biovail and Elan Sign Generic Adalat CC Agreement; Biovail to Accelerate Launch of Adalat CC'S 30mg Dosage.TORONTO--(BW HealthWire)--Oct. 14, 1999-- Biovail Corporation International (NYSE NYSE See: New York Stock Exchange ,TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). :BVF) announced today the acquisition of exclusive marketing rights for the U.S. to Elan Corporation plc's generic versions of Adalat(R) CC in return for certain upfront payments and future royalties. Adalat(R) CC, a Nifedipine nifedipine /ni·fed·i·pine/ (ni-fed´i-pen) a calcium channel blocking agent used as a coronary vasodilator in the treatment of coronary insufficiency and angina pectoris; also used in the treatment of hypertension. product, is prescribed for the treatment of hypertension. Adalat(R) CC had brand sales in excess of $350 million for the twelve months ended June 30, 1999. As a result of this acquisition, Biovail, through its U.S. exclusive marketing subdistributor, Teva Pharmaceuticals USA, will , by launching Elan's 30mg product, be able to market a generic version of Adalat(R) CC's 30 mg dosage strength six months earlier than scheduled. In addition, Biovail was the first to file, and has received tentative 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. approval for, a generic version of Adalat(R) CC's 60 mg dosage strength. As a result, Biovail will enjoy six months of marketing exclusivity after commercial launch. 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. "Safe Harbor" 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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