Healthcare Industry News: Biovail
News Release - April 12, 2006
Biovail Launches Wellbutrin XL to Canadian PhysiciansTORONTO--(HSMN NewsFeed)--April 12, 2006--Biovail Corporation (NYSE:BVF ; TSX:BVF ) announced today that WellbutrinŽ XL, the first once-daily extended-release formulation of bupropion hydrochloride approved for the Canadian market for the treatment of depression in adults, has been officially launched and is commercially available.
WellbutrinŽ XL, is being marketed and distributed by Biovail Pharmaceuticals Canada (BPC), the Canadian sales and marketing division of Biovail Corporation. WellbutrinŽ XL, which received a Notice of Compliance from the Therapeutic Products Directorate (Canada) in January 2006, is available in 150mg and 300mg dosage strengths. In addition to physician calls to introduce the features and benefits of WellbutrinŽ XL, launch elements include sampling, marketing and other promotional activities.
Doug Herman, Vice-President and General Manager of BPC, said that WellbutrinŽ XL is an effective first-line treatment for depression with a low incidence of side effects of greatest concern to patients.
"The favorable side-effect profile of WellbutrinŽ XL is due to its unique dual-mode of action on norepinephrine and dopamine," Mr. Herman said. "As the only first-line anti-depressant that does not affect serotonin, WellbutrinŽ XL has a low risk of sexual dysfunction, weight gain and somnolence."
WellbutrinŽ XL is efficacious in the treatment of depression in adults, and is among the agents recommended for the first-line treatment of major depressive disorder. As a result of the unique dual-mode of action of bupropion (norepinephrine and dopamine), WellbutrinŽ XL is typically not associated with those adverse effects common to agents that affect serotonin, such as sexual dysfunction, weight gain and somnolence.
Since it was launched in the United States in September 2003 by Biovail's marketing partner GlaxoSmithKline, WellbutrinŽ XL has captured 7.4% of the anti-depressant market in the United States. For the month ended February 28, 2006, WellbutrinŽ XL captured 57.9% of new prescriptions written for the WellbutrinŽ brand, including generics.
Canadian Depression Market
WellbutrinŽ XL will participate in the C$770-million depression market in Canada. For the 12-month period ended December 31, 2005, bupropion SR prescriptions grew at more than twice the rate of the overall market.
Depression affects an estimated 5%, or 1.45 million Canadians at any given time. A recent study conducted by Health Canada suggests that depression and distress cost Canadians at least $14.4 billion per year in treatment, medication, lost productivity and premature death. Depression is the second-leading cause of long-term disability among workers.
About WellbutrinŽ XL
WellbutrinŽ XL is the first and only once-daily norepinephrine dopamine reuptake inhibitor for the treatment of depression in adults. The active ingredient in WellbutrinŽ XL, bupropion, acts upon norepinephrine and dopamine, two chemicals in the brain believed to help regulate different aspects of mood, cognition, and behavior. Imbalances in these brain chemicals may be associated with depressed mood and other symptoms of depression. Bupropion has no clinically significant impact on serotonin.
WellbutrinŽ, WellbutrinŽ SR, and WellbutrinŽ XL are trademarks of The GlaxoSmithKline Group of Companies, and are used by Biovail under license.
"Safe Harbor" Statement Under the Private Securities Litigation Reform Act of 1995
To the extent any statements made in this press release contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and within the meaning of the "safe harbor" provisions of applicable Canadian securities legislation. These forward-looking statements relate to, among other things, our objectives, goals, strategies, intentions, plans estimates and outlook, and can generally be identified by the use of words such as "believe", "anticipate", "expect", "intend", "plan", "will", "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements.
Although Biovail believes that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties, and undue reliance should not be placed on such statements. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations include, among other things: acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, regulatory matters including compliance with pharmaceutical regulations, availability of raw materials and finished products, the regulatory environment, the outcome of legal proceedings, consolidated tax-rate assumptions, fluctuations in operating results and other risks detailed from time to time in the Company's filings with the U.S. Securities and Exchange Commission ("SEC"), the Ontario Securities Commission ("OSC"), and other securities regulatory authorities in Canada. Additional information about these factors and about the material factors or assumptions underlying any such forward-looking statements may be found in our current Annual Report on Form 20-F, and in particular under the heading "Risk Factors" under Item 3, Sub-Part D. Biovail cautions that the foregoing list of important factors that may affect future results is not exhaustive. When relying on our forward-looking statements to make decisions with respect to the Company, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. We undertake no obligation to update or revise any forward-looking statement.
About Biovail Corporation
Biovail Corporation is a specialty pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, and commercialization of pharmaceutical products utilizing advanced drug-delivery technologies. For more information about Biovail, visit the Company's Web site at www.Biovail.com.
For further information, please contact Ken Howling at 905-286-3000 or send inquiries to ir@Biovail.com.
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