Form 6-K TEVA PHARMACEUTICAL INDU For: Nov 21
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: 11/21/2016 | By: |
Eyal Desheh |
Name: | Eyal Desheh | |
Title: | Group EVP & CFO | |
Exhibit No. | Description | |
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99.1 | Teva Secures European Approval of Trisenox® for First Line Treatment of Low to Intermediate Risk Acute Promyelocytic Leukemia (APL) | |
Teva Secures European Approval of Trisenox® for First Line Treatment of Low to
Intermediate Risk Acute Promyelocytic Leukemia (APL)
Decision solely based on published academic data endorsing the benefit of Trisenox®
as first chemotherapy-free treatment for APL and marks important advancement for patients in Europe
EU Commission grants an extension of indication to first line use of
Trisenox® in combination with retinoic acid
APL0406 study revealed a 99% overall survival rate in low to intermediate risk APL
patients with first line treatment with Trisenox® in combination with
retinoic acid1
JERUSALEM, November 21, 2016 Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced it has obtained approval from the European Commission for an indication extension of Trisenox® (arsenic trioxide). This marks an important advancement in treatment for Acute Promyelocytic Leukemia (APL) patients in Europe, as it is the first time that a form of acute leukemia can be effectively treated with a regimen that is entirely chemotherapy-free. APL is a rare and aggressive type of acute leukemia that can kill within hours or days if left untreated2. Trisenox®, in combination with retinoic acid, has shown a 99% overall survival rate with almost no relapses after more than four years (50 months) of median follow-up1.
Teva is committed to providing wider access to high-quality medicines to ensure more people can benefit from the treatments they need. Were very pleased by this decision of the European Commission, and we look forward to offering a chemotherapy-free treatment option for all newly diagnosed APL patients, said Rob Koremans, MD, President & CEO, Teva Global Specialty Medicines.
The decision by the European Commission, which follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on October 13, grants marketing authorization for first line use of Trisenox® in the 28 countries of the European Union. The indication extension is for newly diagnosed low to intermediate risk Acute Promyelocytic Leukemia (APL) in combination with retinoic acid. Todays announcement points to a recognition by the European Commission that treating low to intermediate risk APL with a chemo-free regimen of Trisenox® plus retinoic acid can increase survival rates, dramatically reduce the risk of relapse, and help avoid chemotherapy-related side effects, such as the risk of life-threatening infections.
Welcoming the approval, Francesco Lo-Coco, Professor of Haematology and Head of the Laboratory of Integrated Diagnosis of Oncohematologic Diseases, Department of Biomedicine and Prevention, University of Rome Tor Vergata, Italy said, This approval by the European Commission is good news for APL patients as we now have access to a cure for an acute leukemia without using chemotherapy. Moreover, this decision is a very positive endorsement by the European Commission, as it was made based solely on published academic research and studies. From now on, APL patients with non-high risk disease will have access to this chemotherapy-free regimen of Trisenox® plus retinoic acid at diagnosis, which has the potential to increase survival rates while minimizing side effects associated with chemotherapy.
In Europe, approximately 1,500 to 2,000 people are diagnosed with APL each year3. APL, a life-threatening form of leukemia, can cause uncontrollable bleeding leading rapidly to death if left untreated2. The rapid progression of APL leading to early mortality is a substantial problem, affecting up to 30% of patients4. Rapid diagnosis and commencement of treatment is essential to avoid early mortality2,5.
About Acute Promyelocytic Leukemia
Acute Promyelocytic Leukemia is a form of acute myeloid leukemia (AML), a cancer of the
blood-forming tissue (bone marrow). Approximately 5% to 10% of patients initially diagnosed with
AML present with the aggressive sub-type of the condition, APL6.
In normal bone marrow, hematopoietic stem cells produce red blood cells (erythrocytes) that carry oxygen, white blood cells (leukocytes) that protect the body from infection, and platelets (thrombocytes) that are involved in blood clotting. In APL, immature white blood cells called promyelocytes accumulate in the bone marrow. The overgrowth of promyelocytes leads to a shortage of normal white and red blood cells and platelets in the body, which causes many of the signs and symptoms of the condition.
People with APL are especially susceptible to developing bruises, small red dots under the skin (petechiae), nosebleeds, bleeding from the gums, blood in the urine (hematuria), or excessive menstrual bleeding. The most important lethal bleeding sites are pulmonary (35%) and intracranial (65%)7. The abnormal bleeding and bruising occur because leukemic blasts produce anticoagulant factors and substances are released that cause excessive blood clotting, leading as a consequence to a low number of platelets in the blood (thrombocytopenia). The low number of red blood cells (anemia) can cause people with acute promyelocytic leukemia to have pale skin (pallor) or excessive tiredness (fatigue). In addition, affected individuals may heal slowly from injuries or have frequent infections due to the decrease of normal white blood cells that fight infection. Furthermore, the leukemic cells can expand into the bones and joints, which may cause pain in those areas. Other general signs and symptoms may occur as well, such as fever, loss of appetite, and weight loss.
APL is generally diagnosed in much younger patients than in AML (the median age is approximately mid-408,9 for APL patients and 67 for AML patients10), and can be diagnosed in patients of any age.
About Trisenox®
On 5 March 2002, the European Commission granted approval for the Marketing Authorization
Application (MAA) for Trisenox®. The authorization, which was valid throughout the
European Union (EU), was granted to treat patients with relapsed or refractory acute promyelocytic
leukemia (APL) and characterized by the presence of the t(15;17) translocation and/or the presence
of the Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptoralpha (PML/(RAR) gene. Trisenox®,
a targeted drug, degrades the PML- RAR fusion protein. Trisenox® received marketing
authorization in 2000 by the U.S. Food and Drug Administration.
The marketing approval for Trisenox® was granted based on results from a multicenter study in which 40 relapsed APL patients were treated with Trisenox® 0.15 mg/kg until bone marrow remission or a maximum of 60 days. Thirty-four patients (85 percent) achieved complete remission after two cycles. When the results for these 40 patients were combined with those for the 12 patients in a pilot trial, an overall response rate of 87 percent was observed11.
1mL of Trisenox® contains 1mg of arsenic trioxide. Trisenox® is a concentrate for solution for infusion. It is a sterile, clear, colorless, aqueous solution. Trisenox® must be administered under the supervision of a physician who is experienced in the management of acute leukaemias, and special monitoring procedures must be followed.
Study Results
The APL0406 Intergroup GIMEMA-AMLSG-SAL study was a prospective, randomized, multicenter,
open-label, phase III non-inferiority study1. Eligible patients were adults between 18
and 71 years of age with newly diagnosed, genetically proven low- or intermediate-risk APL (WBC at
diagnosis 103 x 109/L). Overall, 276 patients were randomly assigned to
receive ATRA-ATO or ATRA-CHT between October 2007 and January 2013. Of 263 patients evaluable for
response to induction, 127 (100%) of 127 patients and 132 (97%) of 136 patients achieved complete
remission (CR) in the ATRA-ATO and ATRA-CHT arms, respectively (P = .12). After a median follow-up
of 40.6 months, the event-free survival, cumulative incidence of relapse, and overall survival at
50 months for patients in the ATRA-ATO versus ATRA-CHT arms were 97.3%v 80%, 1.9% v 13.9%, and
99.2% v 92.6%, respectively (P , .001, P = .0013, and P = .0073, respectively).
Post-induction events included two relapses and one death in CR in the ATRA-ATO arm and two instances of molecular resistance after third consolidation, 15 relapses, and five deaths in CR in the ATRA-CHT arm. Two patients in the ATRA-CHT arm developed a therapy-related myeloid neoplasm.
References:
1. | Journal of Clinical Oncology, July 11, 2016 as 10.1200/JCO.2016.67.1982.Improved Outcomes With Retinoic Acid and Arsenic Trioxide Compared With Retinoic Acid and Chemotherapy in NonHigh-Risk Acute Promyelocytic Leukemia: Final Results of the Randomized Italian-German APL0406 Trial. Professor Uwe Platzbecker et al. http://jco.ascopubs.org/cgi/doi/10.1200/JCO.2016.67.1982 |
2. | Coombs CC, et al. Blood Cancer J. 2015;5,e304. |
3. | Sant M, Allemani C, Tereanu C, De Angelis R, Capocaccia R, Visser O, et al. Incidence of hematologic malignancies in Europe by morphologic subtype: results of the HAEMACARE project. Blood 2010;116(19):3724-34. |
4. | Lehmann S, Ravn A, Carlsson L, et al. Continuing high early death rate in acute promyelocytic leukemia: a population based report from the Swedish Adult Acute Leukemia Registry. Leukemia 2011;25:112834 |
5. | Lo-Coco F. Blood. 2011;118:1188-9 |
6. | Cicconi L, Lo-Coco F. Ann Oncol. 2016;27:1847-81 |
7. | De la Serna J, et al. Blood. 2008;111:3395-402 |
8. | Howlader N, Noone AM, Krapcho M, et al, eds. SEER Cancer Statistics Review, 1975-2012, National Cancer Institute. Bethesda, MD. http://seer.cancer.gov/csr/1975 2012/, based on November 2014 SEER data submission, posted to the SEER web site, April 2015. Accessed June 8, 2016. |
9. | Lo-Coco F, Cicconi L, Breccia M. Current standard treatment of adult acute promyelocytic leukaemia. Br J Haematol. 2015. doi.10.1111.bjh.13890. |
10. | National Cancer Institute SEER Stat Factsheet Acute Promyelocytic Leukemia http://seer.cancer.gov/statfacts/html/amyl.html accessed 16 Nov 2016 |
11. | Soignet SL, et al. J Clin Oncol. 2001;19:3852-3860. |
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 1,800 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 were $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 integrate Allergan plcs worldwide generic
pharmaceuticals business (Actavis Generics) and to realize the anticipated benefits of the
acquisition (and the timing of realizing such benefits); the fact that following the consummation
of the Actavis Generics acquisition, we are 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
incurred to finance the Actavis Generics acquisition; the fact that for a period of time following
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
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