WOODCLIFF LAKE, N.J., March 20 /PRNewswire-FirstCall/ -- Barr
Pharmaceuticals, Inc. (NYSE: BRL) today confirmed that its subsidiary, Barr
Laboratories, Inc., has initiated a challenge of the patent listed by Otsuka
Pharmaceutical Co., Ltd in connection with its ABILIFY(R) (aripiprazole)
tablets, 2mg, 5mg, 10mg, 15mg, 20mg & 30mg.
Barr's Abbreviated New Drug Application (ANDA) containing a paragraph IV
certification for a generic ABILIFY product was received as acceptable for
filing by the U.S. Food & Drug Administration (FDA) on November 15, 2006, the
first date the FDA could accept an ANDA with a paragraph IV certification for
this product. Following receipt of the notice from the FDA that Barr's ANDA
had been accepted for filing, Barr notified Otsuka, the New Drug Application
(NDA) and patent holder. Barr believes it is one of several companies to file
an application challenging Otsuka's patent.
On March 19, 2007, Otsuka announced it had filed suit in the U.S. District
Court of New Jersey to prevent Barr from proceeding with the commercialization
of its product. This action formally initiates the patent challenge process
under the Hatch-Waxman Act.
ABILIFY (aripiprazole) tablets, 2mg, 5mg, 10mg, 15mg, 20mg & 30mg is
indicated for the treatment of schizophrenia, and for the treatment of acute
manic and mixed episodes associated with Bipolar Disorder. The product had
sales of approximately $1.9 billion in the U.S., based on IMS sales data
ending January 2007.
About Barr Pharmaceuticals, Inc.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company
that operates in more than 30 countries worldwide and is engaged in the
development, manufacture and marketing of generic and proprietary
pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. A
holding company, Barr operates through its principal subsidiaries: Barr
Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its
subsidiaries. The Barr Group of companies markets more than 245 generic and
25 proprietary products in the U.S. and more than 1,200 products globally
outside of the U.S.
Except for the historical information contained herein, the statements
made in this presentation constitute forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. Forward-looking statements can be identified
by their use of words such as "expects," "plans," "projects," "will," "may,"
"anticipates," "believes," "should," "intends," "estimates" and other words of
similar meaning. Because such statements inherently involve risks and
uncertainties that cannot be predicted or quantified, actual results may
differ materially from those expressed or implied by such forward-looking
statements depending upon a number of factors affecting the Company's
business. These factors include, among others: the difficulty in predicting
the timing and outcome of legal proceedings, including patent-related matters
such as patent challenge settlements and patent infringement cases; the
outcome of litigation arising from challenging the validity or non-
infringement of patents covering our products; the difficulty of predicting
the timing of FDA approvals; court and FDA decisions on exclusivity periods;
the ability of competitors to extend exclusivity periods for their products;
our ability to complete product development activities in the timeframes and
for the costs we expect; market and customer acceptance and demand for our
pharmaceutical products; our dependence on revenues from significant
customers; reimbursement policies of third party payors; our dependence on
revenues from significant products; the use of estimates in the preparation of
our financial statements; the impact of competitive products and pricing on
products, including the launch of authorized generics; the ability to launch
new products in the timeframes we expect; the availability of raw materials;
the availability of any product we purchase and sell as a distributor; the
regulatory environment in the markets where we operate; our exposure to
product liability and other lawsuits and contingencies; the increasing cost of
insurance and the availability of product liability insurance coverage; our
timely and successful completion of strategic initiatives, including
integrating companies (such as PLIVA d.d.) and products we acquire and
implementing our new SAP enterprise resource planning system; fluctuations in
operating results, including the effects on such results from spending for
research and development, sales and marketing activities and patent challenge
activities; the inherent uncertainty associated with financial projections;
our expansion into international markets through our PLIVA acquisition, and
the resulting currency, governmental, regulatory and other risks involved with
international operations; our ability to service our significantly increased
debt obligations as a result of the PLIVA acquisition; changes in generally
accepted accounting principles; and other risks detailed in our SEC filings,
including in our Transition Report on Form 10-K/T for the six months ended
December 31, 2006.
The forward-looking statements contained in this presentation speak only
as of the date the statement was made. The Company undertakes no obligation
(nor does it intend) to publicly update or revise any forward-looking
statements, whether as a result of new information, future events or
otherwise, except to the extent required under applicable law.
NOTE TO EDITORS: Barr news releases and corporate information are also
available on Barr's website (http://www.barrlabs.com). For complete
indications, warnings and contraindications, contact Barr Laboratories'
Product Information Department at 1-800-Barr Lab. All trademarks referenced
herein are the property of their respective owners.
Carol A. Cox
Barr Pharmaceuticals, Inc.