UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Teva Pharmaceutical Industries Ltd. |
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(Translation of registrants name into English) | ||||
Israel | ||||
(Jurisdiction of incorporation or organization) | ||||
5 Basel Street, P.O. Box 3190 Petach Tikva 49131 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 | ||||
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): [ ] | ||||
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 | ||||
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): n/a |
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 Ltd. | ||
Date: 10/01/2013 | By: |
Eyal Desheh |
Name: | Eyal Desheh | |
Title: | Chief Financial Officer | |
Exhibit No. | Description | |
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99.1 | TEVA ANNOUNCES LAUNCH OF GENERIC ZEMPLAR® IN THE UNITED STATES | |
TEVA ANNOUNCES LAUNCH OF GENERIC ZEMPLAR®
IN THE UNITED STATES
Jerusalem, October 1, 2013 Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announces the launch of the generic equivalent to Zemplar® (paricalcitol) tablets in the United States as of September 30, 2013. Teva was first to file, making the product eligible for 180 days of marketing exclusivity.
Zemplar® (paricalcitol) Capsules are an active form of vitamin D used to prevent and treat secondary hyperparathyroidism (increased parathyroid hormone levels) in patients with Stage 3 or Stage 4 chronic kidney disease and in Stage 5 patients on dialysis. It is an active form of vitamin D. Marketed by AbbVie Inc., Zemplar® had annual sales of approximately $115 million in the United States, according to IMS data as of June 30, 2013.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) 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 worlds leading generic drug
maker, with a global product portfolio of more than 1,000 molecules and a direct presence in about
60 countries. Tevas branded businesses focus on CNS, oncology, pain, respiratory and womens
health therapeutic areas as well as biologics. Teva currently employs approximately 46,000 people
around the world and reached $20.3 billion in net revenues in 2012.
Tevas 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 managements 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, including our ability to develop, manufacture,
market and sell biopharmaceutical products, competition for our innovative products, especially
COPAXONE® (including competition from innovative orally-administered alternatives, as well as from
potential purported generic equivalents), competition for our generic products (including from
other pharmaceutical companies and as a result of increased governmental pricing pressures),
competition for our specialty pharmaceutical businesses, our ability to achieve expected results
through our specialty, including innovative, R&D efforts, the effectiveness of our patents and
other protections for innovative products, decreasing opportunities to obtain U.S. market
exclusivity for significant new generic products, our ability to identify, consummate and
successfully integrate acquisitions, the effects of increased leverage as a result of recent
acquisitions, the extent to which any manufacturing or quality control problems damage our
reputation for high quality production and require costly remediation, our potential exposure to
product liability claims to the extent not covered by insurance, increased government scrutiny in
both the U.S. and Europe of our agreements with brand companies, potential liability for sales of
generic products prior to a final resolution of outstanding patent litigation, our exposure to
currency fluctuations and restrictions as well as credit risks, the effects of reforms in
healthcare regulation and pharmaceutical pricing and reimbursement, any failures to comply with
complex Medicare and Medicaid reporting and payment obligations, governmental investigations into
sales and marketing practices (particularly for our specialty pharmaceutical products),
uncertainties surrounding the legislative and regulatory pathways for the registration and approval
of biotechnology based products, adverse effects of political or economical instability,
corruption, major hostilities or acts of terrorism on our significant worldwide operations,
interruptions in our supply chain or problems with our information technology systems that
adversely affect our complex manufacturing processes, any failure to retain key personnel or to
attract additional executive and managerial talent, the impact of continuing consolidation of our
distributors and customers, variations in patent laws that may adversely affect our ability to
manufacture our products in the most efficient manner, potentially significant impairments of
intangible assets and goodwill, potential increases in tax liabilities, the termination or
expiration of governmental programs or tax benefits, environmental risks and other factors that are
discussed in our Annual Report on Form 20-F for the year ended December 31, 2012 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 the Company undertakes 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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