Biovail Corporation (NYSE:BVF)(TSX:BVF) today announced that a
subsidiary of the Company has reached an agreement with the United
States Department of Justice (DOJ) in respect of criminal allegations
related to activities surrounding the 2003 commercial launch of Cardizem®
LA. In particular, the allegations relate to prior management’s
actions in 2002 and 2003 in respect of the Cardizem®
LA clinical experience program, titled PLACE (Proving L.A. through
Clinical Experience). The agreement eliminates any criminal liability
for Biovail Corporation arising from this matter, and preserves the
Company’s ability to conduct business in the
United States. Without this agreement, the Company was at risk of being
excluded from doing business with any health program sponsored by the
U.S. federal government. These programs represent a material proportion
of Biovail’s business.
The agreement is subject to approval at a court hearing that is expected
to take place on a date between July 31, 2008 and September 15, 2008.
Under the terms of the agreement, the subsidiary, Biovail
Pharmaceuticals, Inc. (BPI), would plead guilty to charges relating to
making payments to induce purchasing or ordering of Cardizem®
LA in 2003 and would pay $24.6 million to fully settle this matter. As
part of the agreement, Biovail Corporation expects to receive full
releases for all matters related to the DOJ’s
investigation.
“We are pleased to resolve another legacy
action. The agreement with the DOJ represents the fourth such action to
be resolved in the past six months,” said Bill
Wells, Biovail’s Chief Executive Officer. “This
is an important and positive result for Biovail and its shareholders as
the agreement eliminates the significant exposure to the Corporation
related to this matter and should immediately reduce our ongoing legal
expenses.
“As we continue to work to resolve the
regulatory and legal matters that remain outstanding, our primary focus
is on implementing our new strategic focus –
one we believe will enhance value for all shareholders.”
The agreement will not affect any current or future Biovail medicines
approved for use in the United States, and will not affect the continued
marketing of Cardizem® LA.
Caution Regarding Forward-Looking Information and “Safe
Harbor” Statement
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 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, the anticipated impact of this agreement
and the anticipated impact of the Company’s
new strategic focus, and can generally be identified by the use of words
such as “believe”, “anticipate”,
“expect”, “intend”,
“plan”, “will”,
“may”, “should”,
“could” 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 procedure involved in and
the uncertain outcome of legal and regulatory proceedings, the outcome
of the court hearing regarding approval of this agreement, the
anticipated proxy contest in connection with the election of the board
of directors at our upcoming shareholders meeting, and other risks
detailed from time to time in the Company’s
filings with the U.S. 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 under the heading “Risk
Factors” contained in Item 3(D) of Biovail’s
most recent Annual Report on Form 20-F.
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.
