Form 6-K TEVA PHARMACEUTICAL INDU For: Apr 23
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 registrants name into English) | ||||
Israel | ||||
(Jurisdiction of incorporation or organization) | ||||
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 | ||||
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: 04/23/2015 | By: |
Eyal Desheh |
Name: | Eyal Desheh | |
Title: | Group EVP & CFO | |
Exhibit No. | Description | |
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99.1 | Teva Presents Data Comparing Early Treatment with COPAXONE® 40 mg/mL to Delayed Start Treatment at 67th American Academy of Neurology (AAN) Annual Meeting in Washington, D.C. | |
Teva Presents Data Comparing Early Treatment with COPAXONE® 40 mg/mL to Delayed
Start Treatment at 67th American Academy of Neurology (AAN) Annual Meeting in
Washington, D.C.
Results Show Benefits of Early Start of COPAXONE® Three-Times-a-Week
Jerusalem, April 23, 2015 Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) today announces new 36-month data from the placebo-controlled and open-label extension phases of the Glatiramer Acetate Low-frequency Administration (GALA) study evaluating the efficacy and safety of three-times-a-week COPAXONE® (glatiramer acetate injection) 40 mg/mL in patients with relapsing forms of multiple sclerosis. The data will be featured during Poster Session 7 at the 67th American Academy of Neurology (AAN) meeting in Washington, D.C. on Thursday, April 23, 2015 from 2:00 p.m. 6:30 p.m. ET.
The study compared early start (ES) patients (n=834) who received three-times-a-week COPAXONE® 40 mg/mL for 36 months versus delayed start (DS) patients (n=419), who started COPAXONE® after the 12-month placebo-controlled phase of the trial. The data show the adjusted mean annualized relapse rate was significantly lower for ES over 36 months (0.23 vs 0.30, risk ratio [RR]=0.770; P=0.0052). In addition, early treatment with three-times-a-week COPAXONE® 40 mg/mL resulted in a sustained reduction in lesion activity and the evolution of active lesions to chronic black holes. Adverse events observed in the trial were consistent with the established COPAXONE® 40 mg/mL safety profile.
Were pleased to see the sustained results from early treatment with three-times-a-week COPAXONE® 40 mg/mL in this trial, said Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific Officer at Teva. Teva is committed to product innovation and we continue to investigate COPAXONE® to ensure patients and physicians can make informed treatment decisions.
About COPAXONE®
COPAXONE® (glatiramer acetate injection) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. See additional important information at: www.CopaxonePrescribingInformation.com For hardcopy releases, please see enclosed full prescribing information. The COPAXONE® brand is approved in more than 50 countries worldwide, including the United States, Russia, Canada, Mexico, Australia, Israel, and all European countries.
Important Safety Information about COPAXONE®
Patients allergic to glatiramer acetate or mannitol should not take COPAXONE®. Some
patients report a short-term reaction right after injecting COPAXONE®. This reaction can
involve flushing (feeling of warmth and/or redness), chest tightness or pain with heart
palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes of an
injection, last about 15 minutes, and go away by themselves without further problems. During the
postmarketing period, there have been reports of patients with similar symptoms who received
emergency medical care. If symptoms become severe, patients should call the emergency phone number
in their area. Patients should call their doctor right away if they develop hives, skin rash with
irritation, dizziness, sweating, chest pain, trouble breathing, or severe pain at the injection
site. If any of the above occurs, patients should not give themselves any more injections until
their doctor tells them to begin again. Chest pain may occur either as part of the immediate post
injection reaction or on its own. This pain should only last a few minutes. Patients may experience
more than one such episode, usually beginning at least one month after starting treatment. Patients
should tell their doctor if they experience chest pain that lasts for a long time or feels very
intense. A permanent indentation under the skin (lipoatrophy or, rarely, necrosis) at the injection
site may occur, due to local destruction of fat tissue. Patients should follow proper injection
technique and inform their doctor of any skin changes. The most common side effects of
COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection,
flushing, rash, shortness of breath, and chest pain. These are not all of the possible side effects
of COPAXONE®. For a complete list, patients should ask their doctor or pharmacist.
Patients should tell their doctor about any side effects they have while taking
COPAXONE®.
Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions to millions of patients every day. Headquartered in Israel, Teva is the worlds largest generic medicines producer, leveraging its portfolio of more than 1,000 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Tevas net revenues in 2014 amounted to $20.3 billion. For more information, visit www.tevapharm.com.
Tevas Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which 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; competition for our innovative products, especially Copaxone® (including competition from orally-administered alternatives, as well as from potential purported generic equivalents) and our ability to migrate users to our 40 mg/mL version; 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; 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; adverse effects of political or economic 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; the impact of continuing consolidation of our distributors and customers; 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; our potential exposure to product liability claims that are not covered by insurance; any failure to recruit or retain key personnel, or to attract additional executive and managerial talent; any failures to comply with complex Medicare and Medicaid reporting and payment obligations; significant impairment charges relating to intangible assets, goodwill and property, plant and equipment; the effects of increased leverage and our resulting reliance on access to the capital markets; 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, 2014 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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