Form 6-K TEVA PHARMACEUTICAL INDU For: Jan 26
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
Teva Pharmaceutical Industries Ltd. ����������������������������������� |
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(Translation of registrant�s name into English) | ||||
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Israel ����������������������������������� | ||||
(Jurisdiction of incorporation or organization) | ||||
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5 Basel Street, P.O. Box 3190 Petach Tikva 4951033 Israel |
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����������������������������������� (Address of principal executive office) |
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Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:��[x]�Form 20-F����[�]�Form 40-F | ||||
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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):��[�] | ||||
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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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Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934:��[�]�Yes����[x]�No | ||||
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If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b):����n/a� |
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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. |
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� | � | Teva Pharmaceutical Industries Ltd. |
� | � | � |
Date: 01/26/2015 | By: |
Eyal Desheh |
� | Name:� | Eyal Desheh |
� | Title: | Group EVP & CFO |
� | � | � |
Exhibit No. | � | Description |
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99.1 | � | TEVA RECEIVES FDA APPROVAL FOR FIRST GENERIC NEXIUM� DELAYED-RELEASE CAPSULES IN THE UNITED STATES |
� | � | � |
TEVA RECEIVES FDA APPROVAL FOR FIRST GENERIC NEXIUM��DELAYED-RELEASE CAPSULES�IN THE UNITED
STATES
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Jerusalem, January�26, 2015 � Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announces the Food and Drug Administration (FDA)�approval of the first generic equivalent to Nexium�(esomeprazole magnesium) Delayed-Release Capsules in the United States.
Teva is preparing to launch the product in the near future.
Nexium�Delayed-Release Capsules, marketed by AstraZeneca, had annual sales of approximately $6 billion in the United States, according to IMS data as of November�2014.
About Teva
Teva Pharmaceutical Industries Ltd. is a leading global pharmaceutical company, committed to
increasing access to high-quality healthcare by developing, producing and marketing affordable
generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical
ingredients. Headquartered in Israel, Teva is the world�s leading generic drug maker, with a global
product portfolio of more than 1,000 molecules and a direct presence in approximately 60 countries.
Teva�s Specialty Medicines businesses focus on CNS, respiratory, oncology, pain, and women�s health
therapeutic areas as well as biologics. Teva currently employs approximately 45,000 people around
the world and reached $20.3�billion in net revenues in 2013.
Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which 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 develop and commercialize additional pharmaceutical products; competition for our
innovative products, especially COPAXONE�(including competition from orally-administered
alternatives, as well as from potential purported generic equivalents); the possibility of material
fines, penalties and other sanctions and other adverse consequences arising out of our ongoing FCPA
investigations and related matters; our ability to achieve expected results from the research and
development efforts invested in our pipeline of specialty and other products; our ability to reduce
operating expenses to the extent and during the timeframe intended by our cost reduction program;
our ability to identify and successfully bid for suitable acquisition targets or licensing
opportunities, or to consummate and integrate acquisitions; the extent to which any manufacturing
or quality control problems damage our reputation for quality production and require costly
remediation; our potential exposure to product liability claims that are not covered by insurance;
increased government scrutiny in both the U.S. and Europe of our patent settlement agreements; our
exposure to currency fluctuations and restrictions as well as credit risks; the effectiveness of
our patents, confidentiality agreements and other measures to protect the intellectual property
rights�of our specialty medicines;�the effects of reforms in healthcare regulation and
pharmaceutical pricing, reimbursement and coverage; governmental investigations into sales and
marketing practices, particularly for our specialty pharmaceutical products; uncertainties related
to our recent management changes;�the effects of increased leverage and our resulting reliance on
access to the capital markets; any failure to recruit or retain key personnel, or to attract
additional executive and managerial talent; adverse effects of political or economical instability,
major hostilities or acts of terrorism on our significant worldwide operations; interruptions in
our supply chain or problems with internal or third-party information technology systems that
adversely affect our complex manufacturing processes; significant disruptions of our information
technology systems or breaches of our data security;competition for our generic products, both from
other pharmaceutical companies and as a result of increased governmental pricing pressures;
competition for our specialty pharmaceutical businesses from companies with greater resources and
capabilities; decreased opportunities to obtain U.S. market exclusivity for significant new generic
products; potential liability in the U.S., Europe and other markets for sales of generic products
prior to a final resolution of outstanding patent litigation; any failures to comply with complex
Medicare and Medicaid reporting and payment obligations; the impact of continuing consolidation of
our distributors and customers; significant impairment charges relating to intangible assets and
goodwill; potentially significant increases in tax liabilities; the effect on our overall effective
tax rate of the termination or expiration of governmental programs or tax benefits, or of a change
in our business; variations in patent laws that may adversely affect our ability to manufacture our
products in the most efficient manner; environmental risks; and other factors that are discussed in
our Annual Report on Form 20-F for the year ended December�31, 2013 and in our 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 we assume no obligation to update or revise any forward-looking
statement, whether as a result of new information, future events or otherwise.
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