Biovail Corporation
NYSE : BVF
TSX : BVF

Biovail Corporation

January 17, 2006 08:30 ET

Biovail Receives Approval for Wellbutrin® XL to Treat Depression in Canada

TORONTO--(CCNMatthews - Jan 17, 2006) -

Biovail Corporation (NYSE:BVF)(TSX:BVF) today announced that the Therapeutic Products Directorate Canada (TPD) has issued a Notice of Compliance (NOC) for 150mg and 300mg tablet strengths of Wellbutrin® XL, a once-daily, extended-release formulation of bupropion hydrochloride (HCl) for the treatment of major depressive illness in adults.

Upon launch, Wellbutrin® XL will be the first and only once-daily formulation of bupropion available in Canada.

Biovail Pharmaceuticals Canada (BPC), Biovail's Canadian sales and marketing division, will introduce the features and benefits of Wellbutrin® XL to health-care professionals throughout Canada. BPC anticipates launching Wellbutrin® XL late in the first quarter of 2006.

"Once-daily Wellbutrin® XL is an effective first-line treatment for depression with a low incidence of sexual dysfunction, weight gain, and somnolence," 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® 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 and dopamine. As the only agent that does not affect serotonin, Wellbutrin® XL has a low risk of sexual dysfunction, weight gain, and somnolence.

Canadian Depression Market

Wellbutrin® 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® 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® 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® XL

Wellbutrin® XL is the first and only once-daily norepinephrine dopamine reuptake inhibitor for the treatment of depression in adults. The active ingredient in Wellbutrin® 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® 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® XL has become an established once-daily treatment for the symptomatic relief of depression.

Wellbutrin®, Wellbutrin® SR, and Wellbutrin® 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 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. Biovail undertakes no obligation to update or revise any forward-looking statement.

Contact Information

  • Biovail Corporation
    Kenneth G. Howling, 905-286-3000