WOODCLIFF LAKE, N.J., Sept. 6 /PRNewswire-FirstCall/ -- Barr
Pharmaceuticals, Inc. (NYSE: BRL) and Teva Pharmaceutical Industries Ltd.
(Nasdaq: TEVA) today announced that they have entered into an agreement for
the launch of Fexofenadine Hydrochloride 30 mg, 60 mg and 180 mg Tablets, the
generic versions of Aventis Pharmaceuticals' Allegra(R) Tablets. Allegra
tablets had annual sales of approximately $1.4 billion, based on IMS data for
the twelve months ended June 2005.
Under the agreement, Barr has 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. In return, Barr will receive a negotiated
percentage of the gross profit of Teva's product, both during and after the
exclusivity period. Teva will record the revenues resulting from sales of the
product and remit the negotiated percentage of its gross profit to Barr.
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.
"This agreement and launch represent an extraordinary opportunity for
consumers and for both companies," said Bruce L. Downey, Barr's Chairman and
Chief Executive Officer. "However, the courts have yet to resolve the pending
patent litigation concerning our generic products. The agreement with Teva
enables us to maximize the opportunity, while sharing the risk of the ongoing
litigation."
Israel Makov, Teva's President and Chief Executive Officer commented, "The
launch of Fexofenadine represents the culmination of many months of work
between Teva and Barr. It allows us to accelerate the availability of this
important generic product and expands the already large portfolio of generic
pharmaceutical products that we offer to American consumers."
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 tablet product and consequently was granted 180 days
exclusivity, which it has now transferred to Teva. 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.
About Barr
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.
About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the
top 20 pharmaceutical companies and among the largest generic pharmaceutical
companies in the world. The company develops, manufactures and markets generic
and innovative human pharmaceuticals and active pharmaceutical ingredients.
Close to 90% of Teva's sales are in North America and Europe.
Barr Pharmaceuticals, Inc. 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.
Teva Pharmaceutical Industries Ltd. Safe Harbor Statement Under the U. S.
Private Securities Litigation Reform Act of 1995: This release contains
forward-looking statements, which express the beliefs and expectations of
management. Such statements are based on management's current beliefs and
expectations and involve a number of known and unknown risks and uncertainties
that could cause Teva's future results, performance or achievements to differ
significantly from the results, performance or achievements expressed or
implied by such forward-looking statements. Important factors that could cause
or contribute to such differences include whether and when the proposed
acquisition with Ivax Corporation will be consummated and the terms of any
conditions imposed in connection with such closing, the terms and conditions
of the financing utilized by Teva for the Ivax acquisition, Teva's ability to
rapidly integrate Ivax's operations and achieve expected synergies, Teva's
ability to successfully develop and commercialize additional pharmaceutical
products, the introduction of competitive generic products, the impact of
competition from brand-name companies that sell or license their own generic
products under generic trade dress and at generic prices (so called
"authorized generics") or seek to delay the introduction of generic products,
regulatory changes that may prevent Teva from exploiting exclusivity periods,
potential liability for sales of generic products prior to a final court
decision, including that relating to the generic version of Neurontin(R), the
effects of competition on Copaxone(R) sales, the impact of pharmaceutical
industry regulation and pending legislation that could affect the
pharmaceutical industry, the difficulty of predicting U.S. Food and Drug
Administration, European Medicines Association and other regulatory authority
approvals, the regulatory environment and changes in the health policies and
structure of various countries, Teva's ability to successfully identify,
consummate and integrate acquisitions, exposure to product liability claims,
dependence on patent and other protections for innovative products,
significant operations outside the United States that may be adversely
affected by terrorism or major hostilities, fluctuations in currency, exchange
and interest rates, operating results and other factors that are discussed in
Teva's Annual Report on Form 20-F and its other filings with the U.S.
Securities and Exchange Commission. Forward-looking statements speak only as
of the date on which they are made and the Company undertakes no obligation to
update publicly or revise any forward-looking statement, whether as a result
of new information, future developments or otherwise.
SOURCE Barr Pharmaceuticals, Inc.
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Related links:
http://www.barrlabs.com
Company News On-Call:
http://www.prnewswire.com/comp/089750.html
CONTACT:
Carol A. Cox, +1-201-930-3720,
ccox@barrlabs.com, of Barr Pharmaceuticals, Inc.; or Dan
Suesskind, Chief Financial Officer of Teva Pharmaceutical
Industries Ltd., +011-972-2-589-2840, or George Barrett of
President and CEO, Teva North America, +1-215-591-3030, or, Dorit
Meltzer, Director, Investor Relations, +011-972-3-926-7554, of
Teva Pharmaceutical Industries Ltd.
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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