Source: BUSINESS WIRE
Monday, June 22, 2009
Represents Another Solid Step in Transformation to a Leading
Specialty CNS Company
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TORONTO--(BUSINESS WIRE)--Biovail Corporation (NYSE:BVF) (TSX:BVF) today announced that a wholly
owned subsidiary has completed the acquisition of the worldwide
development and commercialization rights to the entire portfolio of
tetrabenazine products, including Xenazine®/Nitoman®
(tetrabenazine tablets), and the associated intellectual property rights
held by Cambridge Laboratories (Ireland) Limited and its affiliates
(“Cambridge”).
Under the terms of the agreement, Biovail has paid $200 million and will
pay an additional $30 million in two tranches over the next 24 months to
acquire the worldwide development, manufacturing, and commercialization
rights to the tetrabenazine product portfolio. This includes a
controlled-release formulation of tetrabenazine in development for
Tourette Syndrome (BVF-018), as well as RUS-350 – an isomer of
tetrabenazine that may enter Phase 2 clinical development in the next 12
months. In addition, Biovail has obtained a broad range of intellectual
property for the product portfolio, including issued and pending patents.
In addition to the U.S. and Canada, where Biovail already held certain
licensing rights through the September 2008 acquisition of Prestwick
Pharmaceuticals, Inc., tetrabenazine is marketed through distribution
agreements in a number of other countries, including Australia, Denmark,
France, Germany, Ireland, Israel, Italy, New Zealand, Portugal, Spain,
Switzerland and the United Kingdom, with license applications pending in
several European territories.
Biovail will earn revenue from the worldwide sales that have been
established through Cambridge’s network of marketing partners in
approved territories. In addition, the agreement enables Biovail to
capture the gross margin earned by Cambridge on its supply of product
for the U.S. and Canadian markets. Biovail has assumed a royalty
obligation to a third party.
As previously disclosed, the transaction is immediately accretive to
revenues and margins, and is expected to provide minimal operating cash
flows in 2009 and in the range of $23 million to $26 million in 2010.
About Xenazine/Nitoman (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.
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.
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.
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 under applicable
Canadian provincial 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, including, without
limitation, statements concerning the terms of the transaction,
anticipated product development and the anticipated impact of the
transaction on our revenues, margins and cash flows, 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,
uncertainties associated with the development, launch and
commercialization of new products, reliance on key strategic alliances,
contractual disagreements with third parties, availability of raw
materials and finished products, the difficulty of predicting the impact
of post-marketing studies on U.S. Food and Drug Administration
approvals, the regulatory environment generally, consolidated tax rate
assumptions, fluctuations in operating results 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.
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.
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.