Biovail Corporation has entered into an agreement with Glaxo Group Limited of England (Glaxo) to acquire the Canadian rights to Wellbutrin SR and Zyban. Through this agreement and upon marketing approval from Canadian authorities, Biovail has the option to market Wellbutrin XL, a once-daily bupropion product for the treatment of depression. Wellbutrin SR is usually prescribed twice daily for the treatment of depression and Zyban 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," 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 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 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 in Canada.
For the time being, GSK Canada shall continue to market, distribute and promote Wellbutrin SR and Zyban 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 per cent over the previous 12 months. The combined annual sales for Wellbutrin SR and Zyban 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 SR in 2002 surpassed US$1.4 billion dollars for the 12 months ended October 2002.