Company to Launch Once-Daily Tramadol Product Shortly
TORONTO, September 4 /CNW/ - Biovail Corporation (NYSE: BVF)(TSX:BVF)
today announced that the Therapeutic Products Directorate (TPD) Canada has
issued a Notice of Compliance (NOC) for 100mg, 200mg and 300mg tablet
strengths of Ralivia(TM), the Company's once-daily, extended-release
formulation of tramadol hydrochloride indicated for the management of pain of
moderate severity in patients who require continuous treatment for several
days or more.
Biovail Pharmaceuticals Canada (BPC), Biovail's Canadian sales and
marketing division, will introduce the features and benefits of Ralivia(TM) to
health-care professionals throughout Canada. BPC anticipates launching
"The receipt of a Notice of Compliance for once-daily Ralivia(TM) is the
first important pillar in the establishment of Biovail's family of
pain-management medicines in Canada," said Scott Smith, Vice-President and
General Manager of BPC. "Ralivia(TM) is formulated using Biovail's proprietary
Smartcoat(TM) technology to provide 24-hour delivery for more constant plasma
concentration and clinical effects with less peak-to-trough fluctuation.
Therefore, Biovail believes that the availability of Ralivia(TM) will offer
health-care practitioners another compelling treatment option for their
patients who suffer from pain of moderate severity."
The Ralivia(TM) formulation approved by the TPD is identical to Biovail's
once-daily formulation of tramadol that received approval from the United
States Food and Drug Administration (FDA) in September 2005. The product,
Ultram(R) ER, was launched in the U.S. and Puerto Rico by Ortho-McNeil, Inc.,
a Johnson & Johnson company, and is the only once-daily, extended-release
formulation of tramadol available in the United States.
Comprehensive Clinical Package
Ralivia(TM) was approved based on clinical and safety data obtained from
four original adequate and well-controlled trials involving more than 3,000
patients who received doses of up to 400mg once daily. Biovail's NDS
submission also included 12 definitive and five supportive pharmacokinetic
Significant Market Opportunity
A significant market opportunity exists for once-daily formulations of
tramadol hydrochloride in the Canadian pain market. Statistics from IMS Health
show that sales for the 12 months ended June 30, 2007 for pain products in
Canada were $872.2 million on 27.3 million total prescriptions.
As with all medications, patients who are prescribed Ralivia(TM) may
experience side effects, which are most likely to present shortly after the
commencement of treatment. The most common side effects identified by patients
taking tramadol include: dizziness, nausea, constipation and headache.
Tramadol is a centrally acting synthetic opioid analgesic, effective in
the treatment of pain. Tramadol has two complementary mechanisms of action:
binding to opioid receptors and inhibition of the reuptake of norepinephrine
Caution Regarding Forward-Looking Information and "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 firstname.lastname@example.org.
For further information:
For further information: Biovail Corporation Nelson F. Isabel,
905-286-3000 Vice-President, Investor Relations and Corporate Communications