MONTVALE, N.J., March 3 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals,
Inc. (NYSE: BRL) today announced that the U.S. District Court for the District
of New Jersey has ruled in favor of its subsidiary, Barr Laboratories, Inc.,
in the challenge of the patent listed by Bayer Schering Pharma, AG in
connection with Bayer Schering's Yasmin(R) (drospirenone and ethinyl
estradiol) oral contraceptive. In his ruling, Judge Peter G. Sheridan found
that the patent at issue was invalid, because it was obvious.
"We are delighted that Judge Sheridan has invalidated the patent on
Yasmin," said Bruce L. Downey, Barr's Chairman and CEO. "We are currently
reviewing the opinion in the case and evaluating all of our options. Clearly,
this is a positive development for the Company and we are evaluating what the
potential impact could be on our earnings guidance for 2008."
Yasmin provides an oral contraceptive regimen consisting of 21 active
tablets each containing 3 mg of drospirenone and 0.03 mg of ethinyl estradiol
and 7 inert tablets. Yasmin is indicated for the prevention of pregnancy in
women who elect to use an oral contraceptive. The product had annual sales of
approximately $572 million for the twelve months ended December 2007, based on
IMS sales data.
Barr filed its Abbreviated New Drug Application (ANDA) containing a
paragraph IV certification for a generic Yasmin product with the U.S. Food &
Drug Administration (FDA) in January 2005, and received notification of the
application's acceptance for filing in February 2005. Following receipt of
the notice from the FDA, Barr notified Berlex, the New Drug Application (NDA)
holder, and Schering AG, the patent owner. In April 2005, Schering AG and
Berlex filed a patent infringement suit against Barr in the U.S. District for
the District of New Jersey. In June 2006, Bayer AG acquired Schering AG. In
November 2007, the patent infringement case was heard in front of Judge
Sheridan.
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 120 generic and 26
proprietary products in the U.S. and approximately 1,025 products globally
outside of the U.S. For more information, visit www.barrlabs.com.
Forward-Looking Statements
Except for the historical information contained herein, the statements
made in this press release 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 press release 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 Pharmaceuticals, Inc. news releases are available
free of charge through PR Newswire's News On-Call site at
http://www.prnewswire.com/comp/089750.html. Barr news releases and corporate
information are also available on Barr's website (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.
CONTACT:
Carol A. Cox
Barr Pharmaceuticals, Inc.
+1-201-930-3720
ccox@barrlabs.com
