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Biovail Acquires Canadian Rights to Wellbutrin SR & Zyban From GlaxoSmithKline

Business Wire, Dec 27, 2002

Business Editors/Health/Medical Writers

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

(NYSE:BVF)(TSX:BVF)

Biovail and GSK Canada Enter into Marketing Agreement: Wellbutrin(R) XL Will Be Registered in Canada and Marketed by Biovail

or Licensee Upon Approval

Biovail Corporation (NYSE:BVF)(TSX:BVF) announced today that it has entered into an agreement with Glaxo Group Limited of England (Glaxo) to acquire the Canadian rights to Wellbutrin(R) SR and Zyban(R). Through this agreement and upon marketing approval from Canadian authorities, Biovail has the option to market Wellbutrin(R) XL, a once-daily bupropion product for the treatment of depression. Wellbutrin(R) SR is usually prescribed twice daily for the treatment of depression and Zyban(R) is administered for the treatment of nicotine addiction as an aid to smoking cessation. Both products are formulations of bupropion hydrochloride.

"This provides Biovail with the option to market our own proprietary once-daily bupropion formulation in Canada under the well-respected trade mark for Wellbutrin(R)," commented Eugene Melnyk, Chairman and CEO of Biovail. "These agreements further reconfirm our continued commitment to expanding our portfolio of branded pharmaceutical products targeting large market opportunities in Canada."

Earlier this year, GlaxoSmithKline USA filed Biovail's once-daily bupropion formulation, Wellbutrin(R) XL, with the United States Food and Drug Administration (FDA). Today's agreement allows Biovail access to information and data from past and future clinical studies conducted by GSK in the U.S. This data and information will be used to support the registration of once-daily Wellbutrin(R) XL in Canada and, upon the product's approval from Canada's Therapeutics and Products Directorate regulatory agency, will be used to support the sale of Wellbutrin(R) in Canada.

For the time being, GSK Canada shall continue to market, distribute and promote Wellbutrin(R) SR and Zyban(R) in Canada.

The total antidepressant market in Canada was valued at over US$450 million for the 12 months ended October 2002 and is growing at a rate of approximately 17% annually. Approximately 18 million prescriptions were written for antidepressants in this same time period reflecting growth of 12% over the previous 12 months. The combined annual sales for Wellbutrin(R) SR and Zyban(R) in Canada are expected to reach over US$30 million in 2002 and are expected to grow significantly over the next five years. U.S. sales for Wellbutrin(R) SR in 2002 surpassed US$1.4 billion dollars for the 12 months ended October 2002.

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.

(R) ZYBAN (bupropion hydrochloride) and (R) WELLBUTRIN (bupropion hydrochloride) are registered trademarks of the GlaxoSmithKline Group of Companies, used under license by Biovail Laboratories Incorporated.

For further information, please contact Ken Howling at 905-286-3000 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.

COPYRIGHT 2002 Business Wire
COPYRIGHT 2008 Gale, Cengage Learning

 

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