Biovail and GlaxoSmithKline Sign Licensing Agreements for Once Daily Formulation of Wellbutrin and Distribution Rights for Zovirax Ointment & Cream.

Business Editors & Health/Medical Writers

TORONTO & LONDON--(BW HealthWire)--Oct. 29, 2001

Biovail Corporation (NYSE, TSE:BVF) and GlaxoSmithKline plc (GSK) today announced that Biovail has licensed to GSK a novel controlled-release, once-daily formulation of bupropion hydrochloride (HCI) for sales and distribution on a world-wide basis.

Bupropion HCI, which is marketed for the treatment of depression as Wellbutrin SR by GSK, is currently sold in a sustained-release, twice daily, dosage format. Under the terms of the Wellbutrin Once Daily agreement, Biovail will manufacture and supply the product to GSK for a share of the future sales of the product. GSK and Biovail will co-promote Wellbutrin SR and, Biovail will have the option to co-promote Wellbutrin Once Daily upon approval, in the United States. GSK and Biovail intend to file a New Drug Application (NDA) for Wellbutrin Once Daily with the United States Food and Drug Administration (FDA) during the first half 2002.

In addition, Biovail has acquired exclusive promotion and distribution rights for Zovirax Ointment for the United States and Puerto Rico. Under the terms of the agreement, GSK will manufacture and supply Zovirax Ointment and Zovirax Cream to Biovail and, in return, Biovail will pay GSK $133 million for certain rights to the product, subject to certain conditions. Biovail will begin promotional efforts related to Zovirax Ointment in January 2002 and intends to launch Zovirax Cream upon FDA approval. In order to gain FDA approval for Zovirax Cream, GSK will work with the FDA to reinstate a New Drug Application (NDA) previously filed by the GSK for the product. GSK will also conduct a paediatric Phase IV study for Zovirax Cream.

Commenting on the agreements, Eugene Melnyk, Chairman of the Board, Biovail Corporation said: "Our agreements with GlaxoSmithKline are the latest example of Biovail's stated mission of continuing to grow and expand our base business and to capitalise on the opportunities that our rich and deep pipeline of controlled-release and FlashDose(R) products represent. Our new association with GlaxoSmithKline for the licensing and promotion of Wellbutrin Once Daily and Wellbutrin SR and, the acquisition of US distribution rights for Zovirax topical products, further demonstrates our commitment to building Biovail into one of North America's premier developers and marketers of pharmaceutical products."

Dr Jean-Pierre Garnier, Chief Executive Officer, GlaxoSmithKline commented: "This agreement with Biovail represents a further strengthening of our late stage product development pipeline and is indicative of our intention to become the partner of choice for those companies wishing to maximise the commercial potential of their products and increase their global presence. The new Wellbutrin Once Daily will offer physicians greater prescribing flexibility, the potential for improved patient convenience and compliance as well as a modified drug release profile."

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.

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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.