Biovail Announces Acquisition of Worldwide Rights to Tetrabenazine

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Mon May 18, 2009 8:00am EDT

Transaction Directly Aligned with Specialty CNS Strategy; Immediately Accretive
To Revenues, Margins & Cash Flows


TORONTO--(Business Wire)--
Biovail Corporation (NYSE:BVF) (TSX:BVF) today announced a wholly owned
subsidiary has entered into a definitive agreement to acquire 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) Ltd and its affiliates. The transaction is anticipated to close within
90 days, subject to customary closing conditions. In November 2008, Xenazine was
launched in the United States, where it has orphan drug status through August
2015 for the treatment of chorea associated with Huntington`s disease. In
Canada, Nitoman has been available since 1996 and is indicated for a number of
hyperkinetic movement disorders, including Huntington`s chorea, Tourette
Syndrome and tardive dyskinesia. Tetrabenazine is marketed through distribution
agreements in a number of 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. 

"This acquisition will be immediately accretive to revenues, margins and
operating cash flows, and is anticipated to be moderately accretive to GAAP
earnings per share in 2010. The transaction represents another solid step in our
transformation to a leading specialty CNS company," said Bill Wells, Chief
Executive Officer of Biovail. "Xenazine is showing strong commercial success in
the U.S. in treating chorea associated with Huntington`s disease. By acquiring
these worldwide rights, we believe we will be able to maximize the value of this
asset in the near term for shareholders. In addition, the acquisition further
expands our specialty CNS pipeline, which bolsters our long-term revenue growth
outlook." 

Under the terms of the agreement, Biovail will make a payment of $200 million
upon closing of the transaction and will pay an additional $30 million in two
tranches over the subsequent 24 months to acquire these 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 a tetrabenazine-derived
new chemical entity (NCE), RUS350 - a next-generation molecule that may enter
Phase 2 clinical development in the next 12 months. 

In addition, Biovail will obtain a broad range of intellectual property for the
product portfolio, including issued and pending patents. The agreement enables
Biovail to capture the gross margin earned by Cambridge on its supply of product
for the US and Canadian markets. Biovail will assume a royalty obligation to a
third party. 

Tetrabenazine tablets in Canada are marketed under the Nitoman brand name by the
Biovail Pharmaceuticals Canada sales force. In the United States, Biovail
supplies Xenazine tablets to its commercialization partner for a variable
percentage of the product`s annual net sales. For net sales up to $125 million,
Biovail`s supply price is 72% of net sales. Beyond $125 million, Biovail`s
supply price is 65% of net sales. Upon closing of the transaction, Biovail will
earn revenue from the worldwide sales that have been established through
Cambridge`s network of marketing partners in approved territories. Biovail
anticipates seeking marketing approval in countries where treatment for chorea
associated with Huntington`s disease will be commercially viable. 

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,
including the terms for such supply and promotion, anticipated clinical
development and the anticipated impact of the transaction on our revenues,
margins, earnings per share 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: the
satisfaction of certain closing conditions by the parties to the transaction,
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. 





Biovail Corporation
Nelson F. Isabel, 905-286-3000
Vice-President, Investor Relations & Corporate Communications 

Copyright Business Wire 2009

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