News: Biovail Announces Canadian Commercial Availability of 1,000 …
Biovail Corporation (NYSE:BVF) (TSX:BVF) today announced the
Canadian launch of 1,000mg dosage strength of Glumetza(TM), a
once-daily, extended-release formulation of metformin hydrochloride
(HCl) for the treatment of type 2 diabetes.
The features and benefits of Glumetza(TM) 1,000mg, which received
a Notice of Compliance (NOC) from the Therapeutic Products Directorate
(TPD) in October 2007, are being introduced to health-care
professionals throughout the country by Biovail Pharmaceuticals Canada
(BPC), the Company’s Canadian sales and marketing division.
“This once-daily dosage represents an important treatment
opportunity for patients with type 2 diabetes who depend on the
efficacy and safety of metformin to control their illness,” says Scott
Smith, Vice-President and General Manager of BPC. “Clinical data
exists to show that reducing the frequency of daily dosing of oral
diabetes medication can cause an improvement in patient compliance and
metabolic control. The launch of Glumetza(TM) 1,000mg is an important
development for the majority of patients who require more than 500mg
of metformin daily as part of their treatment.
“Glumetza(TM) 1,000 mg is an important addition to both the
Glumetza(TM) family of products and to BPC’s expanding portfolio of
products, which now includes Wellbutrin XL(R), Tiazac(R) XC and
Ralivia(TM).”
About Glumetza(TM)
Glumetza(TM) (metformin hydrochloride) extended-release tablets in
500mg and 1,000mg dosage strengths are indicated for the control of
hyperglycemia in adult patients with type 2 diabetes
(non-insulin-dependant, mature onset), as an adjunct to dietary
management, exercise and weight reduction, or when insulin therapy is
not appropriate. Glumetza(TM) may be used as monotherapy, or
concomitantly with a sulfonylurea.
Glumetza(TM) is a once-daily formulation, which must be taken with
food to ensure optimum delivery of metformin to the systemic
circulation. Clinical data demonstrates that administration of
Glumetza(TM) in the fed state significantly increases the systemic
delivery of metformin, compared with the fasted state. Glumetza(TM)
can also be of value in the treatment of obese diabetic patients.
About Diabetes
Diabetes affects an estimated 2.25 million Canadians, and is
increasing by approximately 60,000 new cases each year in Canada
alone. Approximately 90% of diabetics suffer from type 2 diabetes, the
most common metabolic disease in the world and the seventh-deadliest
disease in the Canada. Diabetes is the leading cause of blindness,
end-stage renal disease and non-traumatic loss of limb and can also
lead to heart disease, stroke, high blood pressure, kidney disease and
other serious conditions. In Canada, the public health cost of
diabetes is estimated to be more than C$9 billion per year.
About Biovail Pharmaceuticals Canada (BPC)
BPC is the Canadian sales and marketing division of Biovail
Corporation. Since its entry into the Canadian market in 1997 BPC has
established a reputation for providing quality pharmaceutical products
to Canadian health-care professionals. BPC markets and distributes a
select portfolio of products, including Wellbutrin XL(R), Tiazac(R)
XC, Ralivia(TM), Glumetza(TM), Zyban(R) and Monocor(R).
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 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 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, and other risks detailed from time to time in the
Company’s filings with the Securities and Exchange Commission and the
Canadian Securities Administrators, as well as the Company’s ability
to anticipate and manage the risks associated with the foregoing.
Additional information about these factors and about the material
factors or assumptions underlying such forward-looking statements may
be found in the body of this news release, as well as under the
heading “Risk Factors” contained in Item 3(D) of Biovail’s most recent
Annual Report on Form 20-F/A. 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 at www.biovail.com.
For further information, please contact Nelson F. Isabel at
905-286-3000 or send inquiries to ir@biovail.com.
