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 May 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:
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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):
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Website:
www.tevapharm.com
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Contact: |
Elana Holzman |
Teva
Pharmaceutical Industries Ltd. |
+972 (3)
9267554 |
For immediate release
Teva Reaches Settlement Agreement With AstraZeneca Regarding Generic Entocort® EC Capsules
Jerusalem, May 18, 2010 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it has entered into an agreement with AstraZeneca to settle patent litigation regarding Teva's U.S. generic version of AstraZeneca`s Entocort EC (budesonide) capsules.
Under the terms of the agreement, AstraZeneca has granted Teva an exclusive license to enter the U.S. market with its generic budesonide capsules on February 15, 2012, subject to regulatory approval, or earlier in certain circumstances. Other terms of the settlement are confidential.
Entocort EC (budesonide)
capsules had annual sales of approximately $265 million in the United States,
based on IMS sales data.
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®
and Protonix®, the extent to which any manufacturing or quality
control problems damage our reputation for high quality production, the effects
of competition on sales of our innovative products, especially Copaxone® (including
potential generic and oral competition for Copaxone®), the impact of
continuing consolidation of our distributors and customers, our ability to
identify, consummate and successfully integrate acquisitions, interruptions in
our supply chain or problems with our information technology systems that
adversely affect our complex manufacturing processes, intense competition in
our specialty pharmaceutical businesses, any failures to comply with the
complex Medicare and Medicaid reporting and payment obligations, our exposure
to currency fluctuations and restrictions as well as credit risks, the effects
of reforms in healthcare regulation, adverse effects of political or economical
instability, major hostilities or acts of terrorism on our significant
worldwide operations, increased government scrutiny in both the U.S. and Europe
of our agreements with brand companies, dependence on the effectiveness of our
patents and other protections for innovative products, our ability to achieve
expected results through our innovative R&D efforts, the difficulty of
predicting U.S. Food and Drug Administration, European Medicines Agency and
other regulatory authority approvals, uncertainties surrounding the legislative
and regulatory pathway for the registration and approval of biotechnology-based
products, potentially significant impairments of intangible assets and
goodwill, potential increases in tax liabilities resulting from challenges to
our intercompany arrangements, our potential exposure to product liability
claims to the extent not covered by insurance, the termination or expiration of
governmental programs or tax benefits, current economic conditions, any failure
to retain key personnel or to attract additional executive and managerial
talent, 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 May 18, 2010
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