Biovail Announces FDA Submission for Once-daily Bupropion HCl Formulation by GlaxoSmithKline

Business Wire, August 27, 2002

Business Editors/Health & Medical Writers

TORONTO--(BUSINESS WIRE)--Aug. 27, 2002

Biovail Corporation (NYSE:BVF) (TSE:BVF) announced that GlaxoSmithKline (GSK) has submitted a New Drug Application (NDA) for a once-daily formulation of bupropion HCl. This is a significant step toward formal approval for the product by the FDA. GSK has applied for the tradename Wellbutrin XL(TM) Extended Release Tablets.

In October 2001, Biovail licensed this novel, controlled-release formulation to GSK for sales and distribution on a worldwide basis as part of a multi-faceted deal, which also allowed Biovail to co-promote Wellbutrin SR(R) for five quarters and gave Biovail exclusive promotion and distribution rights for topical presentations of Zovirax(R) in the United States. Under the terms of the Agreements and subject to FDA approval, Biovail will manufacture and supply worldwide trade and sample supply requirements of the once-daily bupropion HCl formulation for GSK. Biovail's supply price is based on a percentage of the net sales for the product and Biovail is responsible for the cost of manufacturing.

Bupropion HCl is currently marketed as Wellbutrin SR(R) by GSK for the treatment of depression and is sold in sustained-release, twice daily and three times daily dosage formats. The drug became available in the U.S. for treatment of depression in 1989. Potentially, the once-daily formulation could offer patients additional dosing convenience.

According to the National Institute of Mental Health, over 18.8 million American adults, or 9.5% of the population, suffer from a depressive illness in any given one year period. The U.S. antidepressant market generates approximately $13.5 billion in U.S. sales and is growing at approximately 15% annually.

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.

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

For further information, please contact Ken Howling at 416-285-6000 or send inquiries to ir@biovail.com.

"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.