Teva Receives Approval For SYNRIBOTM (Omacetaxine Mepesuccinate) for Injection

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Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) approved (omacetaxine mepesuccinate) for Injection to treat 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). The indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with SYNRIBO. It will be available for prescribing shortly.

Previously, CP and AP CML patients who failed on two or more TKIs have had limited treatment options. “While the CML treatment landscape has seen advancements with available TKI treatments, there are still cases where patients may not be able to continue using TKIs due to issues such as resistance, intolerance, suboptimal response, and disease progression,” said Jorge E. Cortes, M.D., deputy chair and professor of medicine in the Department of Leukemia at The University of Texas MD Anderson Cancer Center. “With SYNRIBO, physicians will now have access to another option, offering potential hope to patients who experience treatment failure.”

SYNRIBO received an accelerated approval that allows the FDA to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. The program is designed to provide patients with earlier access to promising new drugs. Full approval is expected following submission of more mature data from pivotal analysis.

“Teva Pharmaceuticals is pleased to bring SYNRIBO to the market for patients who need additional treatment options when others have failed,” said Michael R. Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer of Teva Pharmaceutical Industries Ltd. “SYNRIBO joins TREANDA and TRISENOX as important hematologic treatment options in the Teva Oncology portfolio.”

The approval is based on an analysis of combined data subsets from two Phase II, 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.

Administered subcutaneously, SYNRIBOwill bedosed twice daily for 14 consecutive days of a 28-day cycle at treatment induction, and twice daily for seven consecutive days of a 28-day cycle during maintenance therapy once a response is achieved.

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 one chromosome translocates with another chromosome to form the Philadelphia chromosome. The Philadelphia chromosome contains the Bcr-Abl hybrid gene, which leads to over-production in the bone marrow of tyrosine kinase, an enzyme that causes too many stem cells to develop into white blood cells (granulocytes or blasts).The American Cancer Society estimates that in 2012, there will be 5,430 new cases of CML diagnosed in the United States, and 610 people will die from the disease.

The mechanism of action of SYNRIBO has not been fully elucidated but includes inhibition of protein synthesis. It acts independently of direct Bcr-Abl binding to reduce protein levels of both the Bcr-Abl oncoprotein and Mcl-1 which inhibits apoptosis, in vitro. SYNRIBO also showed activity in mouse models of wild-type and T315I mutated Bcr-Abl CML. It is the first protein synthesis inhibitor for the treatment of CML.

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 1,300 molecules and a direct presence in about 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 46,000 people around the world and reached $18.3 billion in net revenues in 2011.

Teva Oncology is the U.S.-based branded oncology division of Teva Pharmaceutical Industries, Ltd. Teva Oncology is committed to the ever changing world of cancer care with a portfolio and pipeline across cancer therapeutics and supportive care.