MONTVALE, N.J., June 26 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals,
Inc. (NYSE: BRL) today announced that U.S. District Court for Delaware has
ruled in favor of its subsidiary, Barr Laboratories, Inc., in the challenge of
the patent listed by Boehringer Ingelheim Pharmaceuticals, Inc. in connection
with Boehringer Ingelheim's Mirapex(R) Tablets (pramipexole dihydrochloride)
0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg.
In his ruling, District Court Judge Joseph J. Farnan, Jr. found that the
patent claims at issue in the litigation were invalid on the grounds of
nonstatutory double patenting.
Barr's Abbreviated New Drug Application (ANDA) for a generic Mirapex
product received final approval from the U.S. Food and Drug Administration
(FDA) in February 2008. Barr believes that it is the first company to file an
ANDA with a paragraph IV certification for Mirapex Tablets, 0.125mg, 0.25mg,
0.5mg, 1mg & 1.5mg.
“We are very pleased with the Court's favorable decision regarding the patent on Mirapex, and are currently reviewing the opinion in the case and evaluating our options,” said Bruce L. Downey, Barr's Chairman and CEO.
Barr filed its ANDA for generic Mirapex Tablets, 0.25mg containing a
paragraph IV certification with the FDA in May 2005 and in June 2005 amended
its application to include the tablet strengths 0.125mg, 0.5mg, 1mg, and
1.5mg. Following receipt of the notice from the FDA of the application's
acceptance for filing, Barr notified the New Drug Application (NDA) holder and
patent owner. On September 26, 2005, Boehringer Ingelheim filed suit in the
U.S. District Court in Delaware to prevent Barr from proceeding with the
commercialization of its product, formally initiating the patent challenge
process under the Hatch-Waxman Act. In March 2008, the patent infringement
case was heard in front of Judge Farnan.
Mirapex (pramipexole dihydrochloride) had annualized sales of
approximately $381 million for the twelve months ended April 2008, based on
IMS sales data.
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 27
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 and our forecasts; 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 Annual Report on Form 10-K for the year ended December 31,
2007.
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
Carol.Cox@barrlabs.com
