Biovail Announces Generic Voltaren-XR Filing

Business Wire, Dec 3, 1998

TORONTO--(BW HealthWire)--Dec. 3, 1998--Biovail Corporation International (NYSE:BVF) (TSE:BVF) today announced that the Food and Drug Administration (FDA) has accepted an Abbreviated New Drug Application (ANDA) for its generic controlled-release version of Voltaren-XR, a nonsteroidal anti-inflammatory drug (NSAID) for the treatment of osteoarthritis and rheumatoid arthritis. This once daily brand of Diclofenac is marketed by Novartis Pharmaceutical Corporation and represents a generic market opportunity in the U.S. in excess of $100 million.

This represents the fourth ANDA filing accepted by the FDA for Biovail in 1998. Biovail currently has seven controlled-release generic products awaiting approval by the FDA representing brand sales in the U.S. in excess of $2.0 billion. Under the terms of the December 1997 Exclusive Distribution Agreement with a subsidiary of Teva Pharmaceutical Industries Limited, Biovail will earn a $4.0 million fee as a result of the acceptance of this ANDA by the FDA.

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 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.