Barr and Teva To Continue Marketing Fexofenadine Hydrochloride Tablets
WOODCLIFF LAKE, N.J., Jan. 27 /PRNewswire-FirstCall/ -- Barr
Pharmaceuticals, Inc. (NYSE: BRL) today confirmed that the Unites States
District Court for the District of New Jersey has denied a motion filed by
Aventis Pharmaceuticals, Inc. and Albany Molecular Research, Inc. that would
have forced Barr and Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) to
cease marketing Fexofenadine Hydrochloride 30 mg, 60 mg and 180 mg Tablets,
the generic versions of Aventis' Allegra(R) Tablets. On September 6, 2005
Barr and Teva announced that they had entered into an agreement and launched
the Fexofenadine Hydrochloride Tablet products.
"We are extremely pleased that the Court decision will allow American
allergy sufferers to continue to save on their Fexofenadine Hydrochloride
Tablet prescription," said Bruce L. Downey, Barr's Chairman and Chief
Executive Officer. "Since our September launch, consumers have realized
considerable savings as a result of the competition our product has created.
We will continue to defend our launch of this product as we pursue the
underlying patent challenge litigation with Aventis."
Under its agreement with Teva, Barr took 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 period. Barr was the first generic applicant to
file an Abbreviated New Drug Application (ANDA) containing a paragraph IV
patent challenge on the patents related to the Allegra(R) tablet products and
consequently was granted 180 days exclusivity, which it has now transferred to
Teva.
In June 2004 Barr and Teva were granted summary judgment of
non-infringement with respect to three patents, and were granted summary
judgment of invalidity on an additional patent in the case in April 2005.
Several patents remain in the litigation. Although no trial date has been
set, the companies expect that a trial will occur sometime in 2006.
Allegra(R) (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.
Barr Pharmaceuticals, Inc. 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,
2005.
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
+1-201-930-3720
ccox@barrlabs.com
