WOODCLIFF LAKE, N.J., Sept. 21 /PRNewswire-FirstCall/ -- Barr
Pharmaceuticals, Inc. (NYSE: BRL) today confirmed that Aventis
Pharmaceuticals, Inc. along with Albany Molecular Research, Inc. have filed a
motion for a preliminary injunction or expedited trial in the United States
District Court for the District of New Jersey. The motion seeks to enjoin
Barr and Teva Pharmaceutical Industries Ltd. from marketing their generic
versions of Allegra(R) (Fexofenadine Hydrochloride) Tablets, 30 mg, 60 mg and
180 mg, or to expedite the trial in the case. The injunction also seeks to
enjoin Ranbaxy Laboratories, Ltd. and Amino Chemicals, Ltd. from the
commercial production of generic Fexofenadine raw material.
On September 6, 2005, Barr and Teva Pharmaceutical Industries Ltd.
announced that they had entered into an agreement for the launch of
Fexofenadine Hydrochloride, 30 mg, 60 mg and 180 mg Tablets, the generic
version of Aventis Pharmaceuticals Allegra(R) tablets. Under the agreement,
Barr had taken the regulatory steps necessary to permit Teva to obtain final
U.S. Food and Drug Administration approval of Teva's Fexofenadine
Hydrochloride Tablets and to sell the product within Barr's 180-day
exclusivity. Teva launched the product and has been shipping product to
customers since that time.
"We intend to vigorously oppose this effort to prevent the marketing of a
more affordable generic Fexofenadine," said Bruce L. Downey, Barr's Chairman
and Chief Executive Officer.
Allegra (Fexofenadine Hydrochloride) is indicated for the relief of
symptoms associated with seasonal allergic rhinitis and for the treatment of
uncomplicated skin manifestations of chronic idiopathic urticaria in adults
and children 6 years of age and older. Allegra tablets had annual sales of
approximately $1.4 billion, based on IMS data for the twelve months ended July
2005.
Barr filed an ANDA for Fexofenadine Hydrochloride Tablets, 30 mg, 60 mg,
and 180 mg, in June 2001. Following receipt of notice of acceptance from FDA,
Barr notified Aventis of its ANDA filing. Aventis filed suit in the United
States District Court for the District of New Jersey seeking to prevent
approval of Barr's ANDA until after the expiration of various patents, the
last of which expires in 2017.
In July 2004, Barr announced that the U.S. District Court in New Jersey
had granted summary judgment of non-infringement with respect to three patents
in the Company's patent challenge litigation involving Allegra (Fexofenadine
Hydrochloride). On April 1, 2005, the Company announced that the Court
granted summary judgment of invalidity on an additional patent in the case.
The court has yet to rule on five patents related to the Allegra tablet
and capsule products remaining in the litigation -- three method-of-use
patents and two raw material patents. While no trial date has been set, Barr
anticipates that the case may be ready for trial early in 2006.
Barr Pharmaceuticals, Inc. (NYSE: BRL) is a holding company whose
principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals,
Inc., develop, manufacture and market generic and proprietary pharmaceuticals.
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; 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 and products we acquire
and implementing our new 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;
changes in generally accepted accounting principles; and other risks detailed
from time-to-time in our filings with the Securities and Exchange Commission,
including in our Annual Report on Form 10-K for the fiscal year ended June 30,
2004.
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.
SOURCE Barr Pharmaceuticals, Inc.
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http://www.barrlabs.com
Company News On-Call:
http://www.prnewswire.com/comp/089750.html
CONTACT:
Carol A. Cox of Barr Pharmaceuticals, Inc.,
+1-201-930-3720, ccox@barrlabs.com
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.
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