Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) today announced that
its subsidiary, Teva Pharmaceuticals USA, Inc., and Barr Laboratories,
Inc. have signed an agreement with Aventis Pharmaceuticals, Inc.,
sanofi-aventis U.S. LLC and Albany Molecular Research, Inc. to settle
patent litigation involving Teva’s and Barr’s U.S. generic versions of
Aventis Pharmaceuticals’ Allegra® (fexofenadine) 30mg, 60mg and 180mg
tablets including all claims for patent infringement and damages. After
entering into a separate agreement with Barr, Teva launched its generic
fexofenadine tablets in the U.S. in September 2005.
The present agreement releases Barr and Teva for all past and future
activities in connection with the U.S. marketing and sale of Teva’s and
Barr’s generic fexofenadine tablets. Under the terms of the agreement,
Teva and Barr will each pay Aventis about $30 million. In addition, Teva
and Barr will pay Aventis an undisclosed royalty on future U.S. sales.
Under a consent decree related to Sanofi, the agreement is subject to
review by the Federal Trade Commission (FTC), which the parties expect
will require up to 45 days to complete. The parties may prevent the
agreements from becoming effective or terminate the agreements if the
FTC or state attorney generals raise objections that cannot be resolved
by the parties.
About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among
the top 20 pharmaceutical companies in the world and is the world's
leading generic pharmaceutical company. The Company develops,
manufactures and markets generic and innovative human pharmaceuticals
and active pharmaceutical ingredients, as well as animal health
pharmaceutical products. Over 80 percent of Teva's sales are in North
America and Europe.
Safe Harbor Statement under the U.S. Private Securities Litigation
Reform Act of 1995:
This release contains forward-looking statements, which express the
current 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 our
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 risks relating to: our ability to
successfully develop and commercialize additional pharmaceutical
products, the introduction of competing generic equivalents, the extent
to which we may obtain U.S. market exclusivity for certain of our new
generic products and regulatory changes that may prevent us from
utilizing exclusivity periods, competition from brand-name companies
that are under increased pressure to counter generic products, or
competitors that seek to delay the introduction of generic products, the
impact of consolidation of our distributors and customers, potential
liability for sales of generic products prior to a final resolution of
outstanding patent litigation, including that relating to the generic
versions of Allegra®, Neurontin®, Lotrel® and Protonix®, the effects of
competition on our innovative products, especially Copaxone® 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 Agency
and other regulatory authority approvals, the regulatory environment and
changes in the health policies and structures of various countries, our
ability to achieve expected results though our innovative R&D efforts,
our ability to successfully identify, consummate and integrate
acquisitions, including the pending acquisition of Barr Pharmaceuticals
Inc., potential exposure to product liability claims to the extent not
covered by insurance, dependence on the effectiveness of our patents and
other protections for innovative products, significant operations
worldwide that may be adversely affected by terrorism, political or
economical instability or major hostilities, supply interruptions or
delays that could result from the complex manufacturing of our products
and our global supply chain, environmental risks, fluctuations in
currency, exchange and interest rates, and other factors that are
discussed in this report and in our other filings with the U.S.
Securities and Exchange Commission ("SEC").