Biovail Receives Generic Adalat CC Tentative Approval.TORONTO--(BW HealthWire)--June 30, 1999-- Biovail Corporation International (NYSE NYSE See: New York Stock Exchange :BVF)(TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). :BVF.) today announced that it has received tentative approval for its 30mg and 60mg generic versions of Adalat CC (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. ) from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. ("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. "). Adalat CC is indicated for the treatment of hypertension and is marketed by Bayer Corporation. Sales of approximately $357 million were achieved in 1998 for Adalat CC, of which the 60mg strength accounted for approximately 45% and the 30mg strength accounted for 35% of sales, respectively. Biovail was the first company to file an abbreviated new drug application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar ("ANDA ANDA abbr. abbreviated new drug application ") with the FDA for the 60mg strength of Adalat CC and will be entitled to 180 days of marketing exclusivity. A competitor was the first to file for the 30mg strength and that product has received tentative FDA approval. Accordingly, Biovail will be able to launch its 30 mg strength of Adalat CC upon expiry of the competitors exclusivity. Market introduction of Biovail's 60 mg and 30mg strengths, as well as the competitors 30 mg strength will depend upon the settlement of legal and patent issues with Bayer. Upon introduction, Biovail's generic version of Adalat CC will be marketed in the US by Teva Pharmaceuticals USA Inc., one of the premier marketers of generic products in the country. Eugene Melnyk, Chairman of the Board, commented that, "the approval of Adalat CC is an exciting milestone achievement for Biovail and is an added demonstration of the scientific and developmental capability of the company. In addition to Adalat CC, we also have our generic versions of Cardizem CD, Procardia XL, Voltaren SR and Dilacor XR awaiting FDA approval and expect to receive these approvals in due coarse." 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 TPD 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 Securities and Exchange Commission. |
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