TORONTO, November 1 /CNW/ - Biovail Corporation (NYSE: BVF)(TSX:BVF) today
announced that Ralivia(TM), the Company's once-daily tramadol formulation, has
been officially launched in Canada, and is now commercially available.
Ralivia(TM) 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(TM), 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(TM) 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(TM) 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(TM) is the only tramadol formulation indicated for continuous use."
Ralivia(TM), which is available in 100mg, 200mg and 300mg dosage
strengths, is produced using the Company's proprietary Smartcoat(TM)
technology, which provides 24-hour delivery for more constant plasma
concentration and clinical effects with less peak-to-trough fluctuation.
Ralivia(TM) is identical to Biovail's once-daily tramadol formulation that was
approved in September 2005 by the U.S. FDA. That product, Ultram(R) 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
In clinical trials, Ralivia(TM) 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(TM) administered for up to 58 weeks.
Ralivia(TM) 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(TM) 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.
Ralivia(TM) 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(TM) is 300mg a day.
Patients who are prescribed Ralivia(TM) 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(TM) are encouraged to visit the Products
subdirectory on the Company's Web site at www.biovail.com or to call Biovail
Medical Information at 1-866-825-8120.
"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
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
For further information, please contact Nelson F. Isabel at 905-286-3000
or send inquiries to email@example.com.
For further information:
For further information: Biovail Corporation Nelson F. Isabel,
Vice-President, Investor Relations and Corporate Communications, 905-286-3000