SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Report of Foreign Private Issuer
Pursuant to Rule 13a‑16 or 15d‑16
under the Securities Exchange Act of 1934
For the month of March 2010
Commission File Number 0-16174
Teva Pharmaceutical Industries Limited
(Translation of registrant's name into English)
5 Basel Street, P.O. Box 3190
Petach Tikva 49131 Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
|
Form 20-F X |
Form 40-F |
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Contact: |
Elana Holzman |
Teva
Pharmaceutical Industries Ltd. |
972 (3)
926-7554 |
For Immediate Release
Teva Provides Update on Generic Temodar®
Jerusalem, March 17, 2010 - Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that the parties to the patent litigation regarding Barr`s U.S. generic version of Schering`s Temodar® have entered into an agreement pending resolution of Schering`s appeal to the Federal Circuit of the U.S. District Court`s decision holding the `291 Patent unenforceable. Under the terms of the agreement, subject to limited exceptions, Teva will only market a generic product should the Federal Circuit uphold the District Court`s decision. Furthermore, the agreement grants Teva the right to commence selling its generic product as of August 2013, during the period of Schering`s pediatric exclusivity.
About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is
among the top 15 pharmaceutical companies in the world and is the leading
generic pharmaceutical company. The company develops, manufactures and markets
generic and innovative pharmaceuticals and active pharmaceutical ingredients.
Over 80 percent of Teva's sales are in North
America and Western Europe.
Teva's 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, potential liability for sales of generic
products prior to a final resolution of outstanding patent litigation,
including that relating to the generic versions of Neurontin®, Lotrel®, Protonix®
and Eloxatin®, the current economic conditions, 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
effects of competition on our innovative products, especially Copaxone® sales,
including potential oral and generic competition for Copaxone®, dependence on
the effectiveness of our patents and other protections for innovative products,
the impact of consolidation of our distributors and customers, the impact of
pharmaceutical industry regulation and pending legislation that could affect
the pharmaceutical industry, our ability to achieve expected results though our
innovative R&D efforts, the difficulty of predicting U.S. Food and Drug
Administration, European Medicines Agency and other regulatory authority
approvals, the uncertainty surrounding the legislative and regulatory pathway
for the registration and approval of biotechnology-based products, the
regulatory environment and changes in the health policies and structures of
various countries, supply interruptions or delays that could result from the
complex manufacturing of our products and our global supply chain, our ability
to successfully identify, consummate and integrate acquisitions, the potential
exposure to product liability claims to the extent not covered by insurance,
our exposure to fluctuations in currency, exchange and interest rates,
significant operations worldwide that may be adversely affected by terrorism,
political or economical instability or major hostilities, our ability to enter
into patent litigation settlements and the intensified scrutiny by the U.S. government,
the termination or expiration of governmental programs and tax benefits,
impairment of intangible assets and goodwill, environmental risks, and other
factors that are discussed in this report and in our other filings with the
U.S. Securities and Exchange Commission ("SEC").
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Teva Pharmaceutical Industries Ltd. Web Site: www.tevapharm.com
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
(Registrant)
By: /s/ Eyal Desheh
Name:
Eyal Desheh
Title:
Chief Financial Officer
Date March 17, 2010
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