Biovail Launches Wellbutrin XL to Canadian Physicians.TORONTO -- Biovail Corporation (NYSE NYSE See: New York Stock Exchange :BVF BVF Biovail Corporation (stock symbol) BVF Berufsverband der Frauenärzte eV (Muenchen, Germany) BVF Bearing Versus Frequency )(TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension :BVF) announced today that Wellbutrin(R) XL, the first once-daily extended-release formulation of bupropion hydrochloride bu·pro·pi·on hydrochloride n. A drug used to treat depression and nicotine dependence. bupropion hydrochloride Budeprion SR, Budeprion XL, Wellbutrin, Wellbutrin SR, Wellbutrin XL, Zyban approved for the Canadian market for the treatment of depression in adults, has been officially launched and is commercially available. Wellbutrin(R) XL, is being marketed and distributed by Biovail Pharmaceuticals Canada (BPC BPC British Potato Council BPC Brewton-Parker College (Mt Vernon, GA) BPC Bible Presbyterian Church BPC Bangladesh Petroleum Corporation (Chittagong, Bangladesh) BPC British Pharmaceutical Codex ), the Canadian sales and marketing division of Biovail Corporation. Wellbutrin(R) XL, which received a Notice of Compliance from the Therapeutic Products Directorate Therapeutic Products Directorate (TPD) is a Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use, a role performed by the Food and Drug Administration in the United States. (Canada) in January 2006, is available in 150mg and 300mg dosage strengths. In addition to physician calls to introduce the features and benefits of Wellbutrin(R) XL, launch elements include sampling, marketing and other promotional activities. Doug Herman, Vice-President and General Manager of BPC, said that Wellbutrin(R) XL is an effective first-line treatment for depression with a low incidence of side effects Side effects Effects of a proposed project on other parts of the firm. of greatest concern to patients. "The favorable side-effect profile of Wellbutrin(R) XL is due to its unique dual-mode of action on norepinephrine norepinephrine (nôr'ĕpīnĕf`rən), a neurotransmitter in the catecholamine family that mediates chemical communication in the sympathetic nervous system, a branch of the autonomic nervous system. and dopamine dopamine (dōp`əmēn), one of the intermediate substances in the biosynthesis of epinephrine and norepinephrine. See catecholamine. dopamine One of the catecholamines, widely distributed in the central nervous system. ," Mr. Herman said. "As the only first-line anti-depressant that does not affect serotonin, Wellbutrin(R) XL has a low risk of sexual dysfunction, weight gain and somnolence somnolence /som·no·lence/ (som´no-lens) drowsiness or sleepiness, particularly in excess. som·no·lence n. 1. A state of drowsiness; sleepiness. 2. ." Wellbutrin(R) 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 Major depressive disorder A mood disorder characterized by profound feelings of sadness or despair. Mentioned in: Conduct Disorder major depressive disorder . As a result of the unique dual-mode of action of bupropion bupropion /bu·pro·pi·on/ (bu-pro´pe-on) a monocyclic compound structurally similar to amphetamine, used as the hydrochloride salt as an antidepressant and as an aid in smoking cessation. (norepinephrine and dopamine), Wellbutrin(R) 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, Wellbutrin(R) XL has captured 7.4% of the anti-depressant market in the United States. For the month ended February 28, 2006, Wellbutrin(R) XL captured 57.9% of new prescriptions written for the Wellbutrin(R) brand, including generics. Canadian Depression Market Wellbutrin(R) 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. About Depression 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 Wellbutrin(R) XL Wellbutrin(R) XL is the first and only once-daily norepinephrine dopamine reuptake inhibitor Dopamine Reuptake Inhibitors (DARI), Dopamine Uptake Inhibitors, Dopamine Transporter Inhibitors are compounds that inhibit the reuptake of extracellular dopamine back into the presynaptic cell by blocking the cell membrane-spanning dopamine transporter. for the treatment of depression in adults. The active ingredient in Wellbutrin(R) 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. Wellbutrin(R), Wellbutrin(R) SR, and Wellbutrin(R) 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 The Ontario Securities Commission (OSC) is a regulatory agency which administers and enforces securities legislation in the Canadian province of Ontario. The OSC is an Ontario Crown corporation which reports to the Ontario legislature through the Minister of Finance. ("OSC O.S.C. n. short for Order to Show Cause. (See: Order to Show Cause) "), 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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