Form 6-K TEVA PHARMACEUTICAL INDU For: Apr 28
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. |
||||
(Translation of registrants name into English) | ||||
Israel | ||||
(Jurisdiction of incorporation or organization) | ||||
5 Basel Street, P.O. Box 3190 Petach Tikva 4951033 Israel |
||||
(Address of principal executive office) |
||||
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: 04/28/2015 | By: |
Eyal Desheh |
Name: | Eyal Desheh | |
Title: | Group EVP & CFO | |
Exhibit No. | Description | |
|
|
|
99.1 | TEVA CONTINUES TO INVIGORATE INJECTABLE PORTFOLIO WITH THE LAUNCH OF ARGATROBAN INJECTION IN THE UNITED STATES | |
TEVA CONTINUES TO INVIGORATE INJECTABLE PORTFOLIO WITH THE LAUNCH OF
ARGATROBAN INJECTION IN THE UNITED STATES
Jerusalem, April 28, 2015 Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announces the launch of Argatroban Injection in 0.9% sodium chloride, 250 mg/250 mL for intravenous infusion only, in the United States. Argatroban Injection is used to prevent or treat blood clots in adult patients who have developed antibodies to heparin or heparin-like products causing a decrease in platelets (known as heparin-induced thrombocytopenia). Argatroban Injection is also used as a blood thinner in adult patients during percutaneous coronary intervention (PCI), a cardiac procedure, in patients who have had or are at risk for heparin-induced thrombocytopenia.
Argatroban Injection works by blocking a certain natural substance (thrombin) that the body uses to form blood clots. This premixed formulation (250 mg in 250 mL aqueous sodium chloride solution) is supplied in a bag ready for intravenous infusion and does not require further dilution.
Argatroban Injection had annual sales of approximately $22 million in the United States, according to IMS data as of December 2014.
Teva is committed and focused on building a stronger generic injectable business globally. As the number one generics company in the world, we can quickly bring a range of high-quality, cost-effective generic injectable treatments to patients within the doctors office, hospital, or clinic. This month, Teva is also reintroducing Ondansetron Injection USP 40mg/20mL and Mesna Injection.
About Argatroban Injection in 0.9% Sodium Chloride
Argatroban Injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT). Argatroban Injection is also indicated as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI).
Important Safety Information
Argatroban is contraindicated in patients with major bleeding and in patients with a history of hypersensitivity to argatroban. Airway, skin, and generalized hypersensitivity reactions have been reported.
Hemorrhage can occur at any site in the body in patients receiving argatroban. An unexplained fall in hematocrit or hemoglobin or a fall in blood pressure should lead to consideration of a hemorrhagic event. Argatroban Injection should be used with extreme caution in disease states and other circumstances in which there is an increased danger of hemorrhage. Concomitant use of argatroban with antiplatelet agents, thrombolytics, and other anticoagulants may increase the risk of bleeding.
Use caution when administering argatroban to patients with hepatic impairment by starting with a lower dose and carefully titrating until the desired level of anticoagulation is achieved. Use of argatroban in PCI patients with clinically significant hepatic disease or AST/ALT levels = 3 times the upper limit of normal should be avoided.
Anticoagulation effects associated with argatroban infusion at doses up to 40 mcg/kg/min correlate with increases of the activated partial thromboplastin time (aPTT). The concomitant use of argatroban and warfarin results in prolongation of the PT and INR beyond that produced by warfarin alone.
In clinical trials, the most common (> 5%) adverse reactions for HIT patients were dyspnea, hypotension, fever, diarrhea, sepsis, and cardiac arrest. The most common (> 5%) adverse reactions for PCI patients were chest pain, hypotension, back pain, nausea, vomiting and headache.
Please see accompanying Full Prescribing Information.
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.
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.
###
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Alvotech and Teva Announce U.S. FDA Approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab)
- RE Royalties Publishes Green Bond Framework and Report, Assessed as Dark Green, and Announces Investor Appreciation Day
- Kellanova and Shaw's join No Kid Hungry to help end summer hunger for kids and families in Maine
Create E-mail Alert Related Categories
SEC FilingsSign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!