TORONTO--(BUSINESS WIRE)--May. 15, 2009--
Biovail Corporation (NYSE: BVF)(TSX: BVF) today announced that the
Company has received the 2009 Corporate Award from the National
Organization for Rare Disorders (NORD) for the development of Xenazine®
for the treatment of chorea in association with Huntington’s disease.
The Award was presented last night at NORD’s Partners in Progress Gala
in Washington D.C.
In accepting the award, Dr. Robert Ashworth, Biovail’s Vice-President,
Regulatory Affairs said, “This award to Biovail represents the
culmination of a collaborative effort among investigators, patient
advocacy groups, industry and FDA. We gratefully acknowledge the
contribution of another honoree, the Huntington's Disease Society of
America, in educating patients and caregivers about the appropriate use
of Xenazine.”
Dr. Ashworth added, “The greatest validation of efforts in drug
development derives from satisfying an unmet medical need. While
Xenazine is not a cure, it can transform lives devastated by the
uncontrollable movements symptomatic of an unremitting neurodegenerative
disease.”
Biovail acquired North American rights to tetrabenazine through the
September 2008 acquisition of Prestwick Pharmaceuticals, Inc.
About Xenazine (tetrabenazine)
Tetrabenazine is a highly selective and reversible centrally-acting
dopamine depleting drug that works by inhibiting a molecule known as
vesicular monoamine transporter 2 (VMAT2). Xenazine was approved by the
FDA on August 15, 2008, for the treatment of chorea associated with
Huntington’s disease, based on the results of a double-blind,
placebo-controlled, Phase 3 study that found Xenazine significantly
reduced patients’ chorea burden, improved global outcome scores, and was
generally safe and well tolerated. Additional post-marketing preclinical
studies further elucidating the safety profile of the product are being
conducted. Tetrabenazine has been available in Europe for more than 30
years and in Canada since 1996. Full prescribing information is
available on the Investor Relations page of Biovail’s website at www.biovail.com.
Important Safety Information
The most frequent adverse events reported with Xenazine include
sedation/somnolence, fatigue, insomnia, depression, akathisia and
nausea. Xenazine can increase the risk of depression and suicidal
thoughts and behavior (suicidality) in patients with Huntington’s
disease and the drug is therefore contraindicated in patients who are
actively suicidal, and in patients with untreated or inadequately
treated depression. Xenazine is also contraindicated in patients with
impaired hepatic function and in patients taking monoamine oxidase
inhibitors or reserpine. Xenazine was approved with a required Risk
Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of
the drug outweigh its risks, particularly the risks of depression and
suicidal thoughts and actions. REMS is a strategy to manage a known or
potential serious risk associated with a drug or biological product.
About Huntington’s Disease
Affecting an estimated 25,000 Americans, Huntington’s disease is a
devastating neurodegenerative disease that causes progressive movement
disorders, cognitive dysfunction and behavioral changes and is
ultimately a fatal condition. Chorea is the most common symptom,
affecting approximately 90% of Huntington’s disease patients, and is
characterized by excessive, involuntary and repetitive movements, which
are the most visible and dangerous manifestations of Huntington’s
disease and interfere with patients’ abilities to perform activities of
daily living, including dressing, bathing and caring for themselves. For
more information about Huntington’s disease, please visit http://www.hdfoundation.org
or http://www.hdsa.org.
About NORD
The National Organization for Rare Disorders (NORD) is a unique
federation of voluntary health organizations dedicated to helping people
with rare "orphan" diseases and assisting the organizations that serve
them. NORD is committed to the identification, treatment, and cure of
rare disorders through programs of education, advocacy, research, and
service.
Caution Regarding Forward-Looking Information and “Safe Harbor”
Statement
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, and may be forward-looking information within the meaning
defined under applicable Canadian securities legislation (collectively,
"forward-looking statements"). These forward-looking statements relate
to, among other things, our objectives, goals, targets, strategies,
intentions, plans, beliefs, estimates and outlook, and can generally be
identified by the use of words such as "believe", "anticipate",
"expect", "intend", "plan", "will", "may", "target" 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 readers are cautioned not to place undue reliance
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, the risks detailed in our
Management Proxy Circular and from time to time in our filings with the
U.S. Securities and Exchange Commission and the Canadian Securities
Administrators, as well as our 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.
The Company cautions that the foregoing list of important factors that
may affect future results is not exhaustive. When relying on Biovail's
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. Biovail undertakes
no obligation to update or revise any forward-looking statement, except
as required by law.
About Biovail Corporation
Biovail Corporation is a specialty pharmaceutical company engaged in the
formulation, clinical testing, registration, manufacture, and
commercialization of pharmaceutical products. The Company is focused on
the development and commercialization of medicines that address unmet
medical needs in niche specialty central nervous system (CNS) markets.
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.
Source: Biovail Corporation
Biovail Corporation
Nelson F. Isabel, (905) 286-3000
Vice-President,
Investor Relations and Corporate Communications