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Teva Pharmaceutical Industries Limited (TEVA) Announces Full FDA Approval Of SYNRIBO® (Omacetaxine Mepesuccinate) For Injection


2/13/2014 6:55:13 AM

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Teva Announces Full FDA Approval of SYNRIBO® (Omacetaxine Mepesuccinate) for Injection

JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval of SYNRIBO® (omacetaxine mepesuccinate) for injection. This oncology portfolio product received an accelerated approval in October, 2012 with additional clinical trial data required to fulfill post marketing requirements set forth by the FDA.

SYNRIBO is indicated for adult patients with chronic phase (CP) or accelerated phase (AP) chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs).

“With this approval, based on the final analysis of two Phase II trials that evaluated efficacy and tolerability data of SYNRIBO®, we believe healthcare providers can be even more confident in the clinical profile of this important medicine,” said Rob Koremans, M.D., President and CEO, Global Specialty Medicines. “This approval reinforces our ongoing commitment to providing SYNRIBO® to people living with CML who have failed two or more TKI therapies.“

Indication

SYNRIBO® is indicated for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI).

Important Safety Information

Warnings and Precautions

Myelosuppression: Patients with chronic phase and accelerated phase CML who used SYNRIBO® experienced severe and fatal myelosuppression including thrombocytopenia, neutropenia, and anemia. Patients with neutropenia are at increased risk for infections, and should be monitored frequently and advised to contact a physician if they have symptoms of infection or fever. Monitor complete blood counts weekly during induction and initial maintenance cycles and every two weeks during later maintenance cycles, as clinically indicated

Bleeding: SYNRIBO® causes severe thrombocytopenia which increases the risk of hemorrhage. Fatalities from cerebral hemorrhage have occurred. Severe, non-fatal gastrointestinal hemorrhages have also occurred. Monitor platelet counts as part of the complete blood count (CBC) monitoring as recommended. Avoid anticoagulants, aspirin, and nonsteroidal anti-inflammatory drugs (NSAIDs) when the platelet count is <50,000/µL as they may increase the risk of bleeding

Hyperglycemia: SYNRIBO® can induce glucose intolerance. Monitor blood glucose levels frequently, especially in patients with diabetes or risk factors for diabetes. Avoid SYNRIBO® in patients with poorly controlled diabetes mellitus until good glycemic control has been established

Embryo-fetal toxicity: SYNRIBO® can cause fetal harm when administered to a pregnant woman. Women should be advised to avoid becoming pregnant while using SYNRIBO®

Adverse Reactions

Serious adverse reactions (frequency =5%) in chronic phase patients: bone marrow failure, thrombocytopenia, febrile neutropenia, and infections

Serious adverse reactions (frequency =5%) in accelerated phase patients: febrile neutropenia, thrombocytopenia, anemia, diarrhea, and infections

Most common adverse reactions (frequency =20%) in chronic and accelerated phase patients: thrombocytopenia, anemia, neutropenia, diarrhea, nausea, fatigue, asthenia, injection site reaction, pyrexia, infection, and lymphopenia

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

About CML

Chronic myeloid leukemia (also called chronic myelogenous leukemia) is one of four main types of leukemia and is a cancer of the blood and bone marrow. In CML, part of the DNA from chromosome 9 breaks off and trades places with chromosome 22 during cell division. This results in the “Philadelphia chromosome,” which is an abnormal chromosome 22 that contains the BCR-ABL hybrid gene. This hybrid gene leads to over-production of the enzyme tyrosine kinase in the bone marrow, which causes too many stem cells to develop into white blood cells (granulocytes or blasts). The American Cancer Society estimates that in 2014, there will be 5,980 new cases of CML diagnosed in the United States, and 810 deaths from the disease. The prevalence of CML has grown significantly since 2001 after the introduction of new treatments. It is estimated that the prevalence of CML in the United States is 26,359, according to the Leukemia & Lymphoma Society.

About SYNRIBO®

SYNRIBO®, which was originally granted an accelerated approval by the FDA in October 2012, is the first protein synthesis inhibitor for CML. While a detailed understanding of how SYNRIBO® works has not been fully defined, it has been shown to prevent the production of specific proteins. The proteins affected by SYNRIBO® are known as Bcr-Abl and Mcl-1, as shown in laboratory studies not involving patients. These are examples of some of the proteins that are produced in higher levels by cancerous CML cells and help drive the disease. As a protein synthesis inhibitor, the way SYNRIBO® is believed to work does not directly depend on Bcr-Abl binding.

For Full Prescribing Information, click here.

About the Phase 2 Pivotal Studies (202 and 203)

The original approval of SYNRIBO® was based on an analysis of combined data subsets from two Phase 2, open-label, multicenter studies. The pooled analysis included patients who had received 2 or more approved TKIs and, at a minimum, had evidence of resistance or intolerance to dasatinib and/or nilotinib. 47% of CP patients and 63% of AP patients had failed treatment with imatinib, dasatinib, and nilotinib. The majority of patients had also received other treatments including hydroxyurea, interferon, and cytarabine.

For CP patients, 18% (14/76) achieved a major cytogenetic response (MCyR) with a mean time to MCyR onset of 3.5 months. The median duration of MCyR for these patients was 12.5 months (Kaplan-Meier estimate).

For AP Patients, 14% (5/35) achieved a major hematologic response (MaHR) with a mean time to response onset of 2.3 months. The median duration of MaHR for these patients was 4.7 months (Kaplan-Meier estimate).

Most common adverse reactions (frequency =20%) in chronic and accelerated phase patients: thrombocytopenia, anemia, neutropenia, diarrhea, nausea, fatigue, asthenia, injection site reaction, pyrexia, infection, and lymphopenia

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 world's leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in approximately 60 countries. Teva's branded businesses focus on CNS, oncology, pain, respiratory and women's health therapeutic areas as well as biologics. Teva currently employs approximately 45,000 people around the world and reached $20.3 billion in net revenues in 2013.

Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:

This release contains forward-looking statements, which are based on management’s 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); 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; our potential exposure to product liability claims that are not covered by insurance; 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; uncertainties related to our recent management changes; the effects of increased leverage and our resulting reliance on access to the capital markets; any failure to recruit or retain key personnel, or to attract additional executive and managerial talent; adverse effects of political or economical 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; 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; any failures to comply with complex Medicare and Medicaid reporting and payment obligations; the impact of continuing consolidation of our distributors and customers; significant impairment charges relating to intangible assets and goodwill; 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, 2013 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.

Contacts

Teva Pharmaceutical Industries Ltd.
IR:
Kevin C. Mannix
United States
215-591-8912
or
Ran Meir
United States
215- 591-3033
or
Tomer Amitai
Israel
972 (3) 926-7656
or
PR:
Iris Beck Codner
Israel
972 (3) 926-7687
or
Denise Bradley
United States
215-591-8974

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