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Biovail Announces Voluntary Recall of Certain Lots of Ultram(R) ER 100mg Tablets
TORONTO--(BUSINESS WIRE)--Dec. 30, 2008--Biovail Corporation today announced a voluntary recall of certain lots
of Ultram(R) ER (extended-release tramadol hydrochloride) 100mg tablets
from pharmacies and wholesalers. Biovail is taking this action as a
result of certain lots being out-of-specification by approximately 1%
with respect to maximum dissolution at the eight-hour mark. This minor
dissolution variance does not impact patient health or safety.
Importantly, the root cause of the dissolution variance, which relates
to excipients used in the coating process during the manufacturing of
the tablets, has been identified and corrective measures are currently
being implemented. Biovail estimates that the recall will negatively
impact Ultram(R) ER revenues by $4.4 million in the fourth quarter of
2008, the majority of which is expected to be recognized in the first
quarter of 2009 as replacement shipments of Ultram(R) ER 100mg tablets are
made to Biovail's marketing partner, PriCara, a division of
Ortho-McNeil-Janssen Pharmaceuticals, Inc. In addition, the voluntary
recall is expected to result in inventory and administrative expenses of
approximately $3.0 million in the fourth quarter of 2008. At this time,
Biovail does not anticipate any product shortages at the pharmacy level.
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 anticipated impact to
fourth-quarter 2008 Ultram(R) ER revenues, the expected inventory and
administrative costs associated with the recall, the timing of expected
shipments of replacement Ultram(R) ER 100mg product, the anticipated level
of supply at pharmacies, 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, including, but not limited to,
factors and assumptions regarding prescription trends, pricing and the
formulary and/or Medicare/Medicaid positioning for our products, the
competitive landscape in the markets in which we compete, including, but
not limited to, the availability or introduction of generic formulations
of our products, timelines associated with the development of, and
receipt of regulatory approval for, our new products, 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 and Canadian
Therapeutic Products Directorate approvals, acceptance and demand for
new pharmaceutical products, the impact of competitive products and
pricing, uncertainties associated with the development, acquisition and
launch of new products, reliance on key strategic alliances, contractual
disagreements with third parties, availability of raw materials and
finished products, the regulatory environment, the expense, timing and
uncertain outcome of legal and regulatory proceedings and settlements
thereto, market liquidity for our common shares and our satisfaction of
applicable laws for the repurchase of our common shares, availability of
capital, satisfaction of applicable laws for dividend payments and the
ability to generate operating cash flow, the continuation of the recent
financial market turmoil, 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 and contained in Biovail's Form
6-K for the quarterly period ended September 30, 2008.
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.
CONTACT: Biovail Corporation
Nelson F. Isabel, 905-286-3000
Vice-President, Investor Relations and
Corporate Communications
Source: Biovail Corporation
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