Form 6-K TEVA PHARMACEUTICAL INDU For: Jun 24
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: 06/24/2016 | By: |
Eyal Desheh |
Name: | Eyal Desheh | |
Title: | Group EVP & CFO | |
Exhibit No. | Description | |
|
|
|
99.1 | Teva Receives CHMP Positive Opinion for CINQAERO® (reslizumab) | |
Teva Receives CHMP Positive Opinion for CINQAERO® (reslizumab)
Add-On Therapy Targeting IL-5 in Adults with Severe Eosinophilic Asthma Pending
Marketing Authorization in Europe
Jerusalem, June 24, 2016 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for CINQAERO® (reslizumab), a humanized interleukin 5 antagonist monoclonal antibody for add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment.
As a company committed to providing medicines and solutions for people around the world living with respiratory disease, Teva is very pleased to report a positive opinion by CHMP for the first intravenous anti-IL-5 biologic therapy for severe eosinophilic asthma, said Rob Koremans, MD, President and CEO of Teva Global Specialty Medicines. In clinical trials, reslizumab was effective in reducing asthma exacerbations, improving lung function and improving asthma-related quality of life measures. It is our hope that we can expand the availability of reslizumab globally and soon bring this important treatment option to a specific group of severe eosinophilic asthma patients in Europe who struggle to control their symptoms despite todays standard of care.
The CHMP opinion is based on review of a Marketing Authorization Application (MAA) containing efficacy and safety data from Tevas global development program in asthma. The clinical trial program consisted of five placebo-controlled studies which demonstrated the efficacy and/or safety profile in a population of 1,028 adult and adolescent asthma patients treated with reslizumab 3 mg/kg that were inadequately controlled with inhaled corticosteroid (ICS)-based therapies. Three of these studies constituted the Phase III program in patients with asthma and elevated blood eosinophils greater than 400 cells/mcL, where reslizumab was administered for up to 52 weeks. They demonstrated that treatment with reslizumab reduced the annual rate of asthma exacerbations in the two 52-week trials by 50 and 59 percent, respectively. In addition, reslizumab was associated with significant improvement in lung function, patient-reported asthma control and asthma-related quality of life measures. The most commonly reported adverse reaction during treatment was increased blood creatinine phosphokinase, which occurred in approximately two percent of patients. These were mostly mild, transient, asymptomatic and did not lead to treatment discontinuation. Adverse reactions of myalgia and anaphylactic reaction were uncommon and occurred in less than one percent of patients.
The CHMP positive opinion is a formal recommendation to grant marketing authorization for reslizumab. The recommendation will now be reviewed by the European Commission, which has authority to approve medicines for use in the 28 countries of the European Union along with Norway, Liechtenstein and Iceland. The final decision by the European Commission is expected in the second half of 2016.
About CINQAERO® (reslizumab)
CINQAERO® (reslizumab) is a humanized interleukin-5 (IL-5) antagonist monoclonal
antibody (IgG4 kappa). IL-5 is the most selective eosinophil-active cytokine known and plays a
major role in the maturation, activation and survival of eosinophils. In asthma patients, the
eosinophilic phenotype is associated with compromised lung function, more frequent symptoms, and
increased risk of exacerbations. Reslizumab binds to human IL-5 and prevents it from binding to the
IL-5 receptor, thereby reducing eosinophilic inflammation. Reslizumab is currently approved and
marketed in the United States as CINQAIR® (reslizumab) Injection for intravenous use
with pending regulatory approvals in other markets.
About Teva Respiratory
Teva Respiratory develops and delivers high-quality treatment options for respiratory conditions, including asthma, COPD and allergic rhinitis. The Teva Respiratory portfolio is centered on optimizing respiratory treatment for patients and healthcare providers through the development of novel delivery systems and therapies that help address unmet needs. The companys respiratory pipeline and clinical trial program are based on drug molecules delivered in proprietary dry powder formulations and breath-actuated device technologies, as well as a targeted biologic treatment for severe asthma. Through research and clinical development, Teva Respiratory continually works to expand, strengthen and build upon its treatment portfolio to positively impact the lives of the millions of patients living with respiratory disease.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by 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 2015 amounted to $19.7 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 specialty
products, especially Copaxone® (which faces competition from orally-administered alternatives and a
generic version); our ability to consummate the acquisition of Allergan plcs worldwide generic
pharmaceuticals business (Actavis Generics) and to realize the anticipated benefits of such
acquisition (and the timing of realizing such benefits); the fact that following the consummation
of the Actavis Generics acquisition, we will be dependent to a much larger extent than previously
on our generic pharmaceutical business; potential restrictions on our ability to engage in
additional transactions or incur additional indebtedness as a result of the substantial amount of
debt we will incur to finance the Actavis Generics acquisition; the fact that for a period of time
following the consummation of the Actavis Generics acquisition, we will have significantly less
cash on hand than previously, which could adversely affect our ability to grow; 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
investments in our pipeline of specialty and other products; 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; competition for our generic products, both from other pharmaceutical
companies and as a result of increased governmental pricing pressures; 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 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, 2015 and in our other filings with the U.S. Securities and Exchange
Commission (the SEC). 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 statements or other
information, 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)
- Jesper and Jesse Will Work Together Again at rabbit!
- Bragar Eagel & Squire, P.C. Is Investigating Zoetis, and Morgan Stanley and Encourages Investors to Contact the Firm
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!