Biovail Launches Ralivia™ To Canadian Physicians

Main Category: Pain / Anesthetics
Article Date: 06 Nov 2007 - 9:00 PDT

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Biovail Corporation (NYSE:BVF)(TSX:BVF) announced that Ralivia™, the Company's once-daily tramadol formulation, has been officially launched in Canada, and is now commercially available. Ralivia™ is indicated for the management of pain of moderate severity in patients who require continuous treatment for several days or more.

The features and benefits of Ralivia™, which received a Notice of Compliance from the Therapeutic Products Directorate on August 31, are being introduced to health-care professionals throughout the country by Biovail Pharmaceuticals Canada, the Company's Canadian sales and marketing division.

"For patients with chronic pain, Ralivia™ provides comparable efficacy to non-steroidal anti-inflammatory drugs (NSAIDs) and COX-2 inhibitors without the long-term cardiovascular and gastrointestinal risks associated with their continuous use," said Scott Smith, Vice-President and General Manager of BPC. "Ralivia™ is the only once-daily tramadol formulation that has also been approved by the United States Food and Drug Administration (FDA), and the only one with over 20 months of U.S. patient experience, during which time approximately 1.6 million prescriptions have been written. Further, Ralivia™ is the only tramadol formulation indicated for continuous use."

Ralivia™, which is available in 100mg, 200mg and 300mg dosage strengths, is produced using the Company's proprietary Smartcoat™ technology, which provides 24-hour delivery for more constant plasma concentration and clinical effects with less peak-to-trough fluctuation. Ralivia™ is identical to Biovail's once-daily tramadol formulation that was approved in September 2005 by the U.S. FDA. That product, Ultram® ER, was launched in the U.S. and Puerto Rico in February 2006 by Ortho-McNeil, Inc., a Johnson & Johnson company, and to date is the only once-daily tramadol in the U.S.

Clinical Trials

In clinical trials, Ralivia™ was studied in more than 3,000 patients with chronic, moderate-to-severe pain due to osteoarthritis of the knee and/or hip, and low back pain, in four 12-week, randomized, double-blind, parallel-group, placebo-controlled trials. An additional study confirmed the safety and efficacy of Ralivia™ administered for up to 58 weeks.

Ralivia™ has been shown to produce significant reductions in pain intensity relative to placebo as early as the first day of treatment, with analgesic efficacy increasing throughout the first four weeks of treatment. Ralivia™ has also been shown to produce significant improvements in sleep in approximately 60% of patients, including improvements in sleep quality, trouble falling asleep, and awakening by pain at night and in the morning.

Dosage Regimen

Ralivia™ should normally be started at a dose of 100mg once daily, and may gradually be increased by 100mg increments every five days, as necessary, and depending upon tolerability, for the relief of pain. The maximum dose of Ralivia™ is 300mg a day.

Safety Precautions

Patients who are prescribed Ralivia™ may experience side effects, including dizziness, nausea, constipation and headache. These side effects are most likely to present shortly after the commencement of treatment. Patients in whom these side effects persist should contact their doctor immediately.

Tramadol has a potential to cause psychic and physical dependence. Tramadol should not be used in opioid-dependent patients. In patients with a tendency to abuse drugs or a history of drug dependence, and in patients who are chronically abusing opioids, treatment with tramadol is not recommended. Withdrawal symptoms may occur following abrupt discontinuation of therapy. Patients on prolonged therapy should be withdrawn gradually from tramadol if it is no longer required for pain control.

Patients and health-care professionals who wish to obtain more information about Ralivia™ are encouraged to visit the Products subdirectory on the Company's Web site at http://www.biovail.com.

"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.

http://www.biovail.com