Biovail Receives Approval for Wellbutrin(R) XL to Treat Depression in Canada.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) today announced that 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 (TPD TPD Tons Per Day TPD Therapeutic Products Directorate TPD Total and Permanent Disablement (insurance) TPD Temperature Programmed Desorption TPD Temporary Partial Disability (insurance) ) has issued a Notice of Compliance (NOC (Network Operations Center) A central or regional location for monitoring a large network. Also called a "network management center" (NMC), "service management center" (SMC) or "network control center" (NCC), a NOC may be used to manage a large enterprise network, ) for 150mg and 300mg tablet strengths of Wellbutrin(R) XL, a 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 (HCl) for the treatment of major depressive illness in adults. Upon launch, Wellbutrin(R) XL will be the first and only once-daily formulation 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. available in Canada. 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 ), Biovail's Canadian sales and marketing division, will introduce the features and benefits of Wellbutrin(R) XL to health-care professionals throughout Canada. BPC anticipates launching Wellbutrin(R) XL late in the first quarter of 2006. "Once-daily Wellbutrin(R) XL is an effective first-line treatment for depression with a low incidence 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. ," said Douglas Herman, Vice-President and General Manager of BPC. "This tolerability profile is important, given that drug-related side effects of anti-depressants are a major reason why treatment may be discontinued." First-Line Efficacy with Excellent Tolerability Profile Wellbutrin(R) XL is efficacious in the treatment of depression, and is recommended by Canadian depression guidelines for first-line use. It is unique among first-line anti-depressants due to its 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. . As the only agent that does not affect serotonin, Wellbutrin(R) XL has a low risk of sexual dysfunction, weight gain, and somnolence. Canadian Depression Market Wellbutrin(R) XL will vie for a share of the C$760-million depression market in Canada. For the 12-month period ended November 30, 2005, bupropion SR prescriptions grew at more than twice the rate of the overall market. Safety Precautions As with all medications, patients who are prescribed Wellbutrin(R) XL may experience side effects, which are most likely to present shortly after the commencement of treatment. The most common side effects that occurred in three pivotal, controlled, clinical trials with Wellbutrin(R) XL (greater than or equal to 5%) were headache, dry mouth, nausea, constipation, insomnia, dizziness, diarrhea, anxiety and decreased appetite. Seizure is a rare but potentially serious side effect of anti-depressant agents, including bupropion. It can occur in approximately one in 1,000 patients. About Depression Depression affects an estimated 1.4 million Canadians at any given time and is responsible for over C$3 billion in direct medical costs. It 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. Biovail developed the formulation for Wellbutrin(R) XL and in October 2001, entered into a distribution-and-supply agreement with GlaxoSmithKline for the United States and the rest of the world, excluding Canada. Since it was launched in the United States in September 2003, Wellbutrin(R) XL has become an established once-daily treatment for the symptomatic relief of depression. Wellbutrin(R), Wellbutrin(R) SR, and Wellbutrin(R) XL are trademarks of The GlaxoSmithKline Group of Companies, and are used by Biovail under license. 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. "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 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. We have based these forward-looking statements on our current expectations and projections about future events. Our actual results could differ materially from those discussed in, or implied by, these forward-looking statements. Forward-looking statements are identified by 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. Forward-looking statements include, but are not necessarily limited to, risks and uncertainties, including the difficulty of predicting U.S. Food and Drug Administration and Canadian Therapeutic Products Directorate 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, tax rate assumptions, availability of raw materials and finished products, the regulatory environment, the outcome of legal proceedings, fluctuations in operating results and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission and 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. . Biovail undertakes no obligation to update or revise any forward-looking statement. |
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