TORONTO, August 8 /CNW/ - Biovail Corporation (NYSE: BVF)(TSX:BVF) today
announced that a subsidiary, Biovail Laboratories International SRL, has
entered into a license and development agreement with an undisclosed,
privately held, drug-development company for the exclusive global rights to
BVF-324, a novel product for the treatment of a prevalent sexual dysfunction.
The agreement allows for the licensing of clinical data, intellectual
property and the rights to develop, manufacture and market BVF-324 globally.
In return, Biovail has paid an upfront fee, and is contingently obligated to
make additional milestone payments, including upon the initiation of the first
Phase III trial for the product and upon the first commercial sale of the
product in the United States. The agreement also stipulates that Biovail make
tiered, single-digit royalty payments on net commercial sales of the product.
"This agreement provides Biovail the opportunity to enter the
multi-billion-dollar, global sexual-dysfunction market with a novel treatment
option that has generated robust Phase II data, and that has intellectual
property protection beyond 2020 through a method-of-use patent," said Dr.
Douglas Squires, Biovail's Chief Executive Officer. "This exciting product has
the potential to address a large unmet clinical need, and to make a
significant difference in the lives of millions of men and women."
A meeting with the U.S. Food and Drug Administration to discuss the
development program for BVF-324 is scheduled for the Fall. Following a
positive outcome, Biovail would anticipate initiating Phase III studies for
the product in the first half of 2008, which could lead to a New Drug
Application (NDA) filing in mid-2009.
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 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 of the "safe harbor" provisions
of 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,
expectations regarding intellectual property protection, expectations
regarding the potential impact of BVF-324, and expectations regarding the
initiation of Phase III studies and the filing of an NDA, 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
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
difficulty of predicting U.S. Food and Drug Administration, Canadian
Therapeutic Products Directorate and European regulatory approvals, acceptance
and demand for new pharmaceutical products, the impact of competitive products
and pricing, new product development and launch, reliance on key strategic
alliances, availability of raw materials and finished products, the regulatory
environment, tax rate assumptions, the outcome of legal proceedings,
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
Ontario Securities Commission, 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.
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 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,
Vice-President, Investor Relations and Corporate Communications, 905-286-3000