Biovail Receives Hart-Scott-Rodino Approval; Biovail Begins Co-Promotion of Wellbutrin SR Immediately; Initiates 500 Person Sales Force Expansion Program

Business Wire, Dec 10, 2001

Business Editors & Health/Medical Writers

TORONTO--(BW HealthWire)--Dec. 10, 2001

Biovail Corporation (NYSE:BVF)(TSE:BVF) today announced that the Federal Trade Commission has allowed the waiting period under the Hart-Scott-Rodino Antitrust Improvement Act of 1976 to expire with respect to the Agreement between Biovail and GlaxoSmithKline, thus allowing the implementation of the Agreement. On October 29, 2001, Biovail and GlaxoSmithKline (GSK) announced that they had entered into multiple agreements associated with Biovail's licensing to GSK a novel controlled-release, once-daily formulation of bupropion hydrochloride (HCI), co-promotion arrangements for Wellbutrin(R) SR and Biovail's acquisition of the U.S. marketing rights to the topical anti-viral Zovirax(R) line from GSK.

Biovail intends to add approximately 500 sales representatives, complementing its current 400 person North American sales organization beginning early in 2002. This expanded sales force will become a permanent and strategic asset through which the Company intends to launch internally developed products as well as a number of acquired product opportunities.

Biovail will begin promoting Wellbutrin(R) SR with GSK immediately. Wellbutrin(R) SR, a twice-daily medication for the treatment of depression, is currently marketed by GSK in the U.S. with revenues in excess of $900 million.

Biovail and GSK expect to submit the once-daily formulation of bupropion HCI to the Food and Drug Administration (FDA) for approval in the first half of 2002 and intend to launch the product during the first half of 2003. Biovail will manufacture and supply GSK on a worldwide basis for all current and future indications and will receive a percentage of net sales for manufacturing and supplying the product.

In addition, Biovail will complete the acquisition of the U.S. marketing and distribution rights to GSK's Zovirax(R) topical anti-viral product line (Ointment and Cream preparations) effective January 1, 2002 for $133 million, subject to certain conditions. Beginning on that date, Biovail will receive the financial benefits associated with marketing and distributing Zovirax(R) Ointment. The Zovirax(R) Ointment product line is currently generating in excess of $70 million and is prescribed for the management of initial herpes genitalis. As part of the Acquisition Agreement, GSK will complete the filing of a New Drug Application (NDA) for Zovirax(R) Cream. The Zovirax(R) Cream has shown promising clinical results in the treatment of cold sores and will target a $700 million market in the U.S. Biovail plans to launch Zovirax(R) Cream upon FDA approval expected in the first half of 2003.

Biovail Corporation is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, sale and promotion of pharmaceutical 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 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.