Teva Receives Approval For SYNRIBOTM (Omacetaxine Mepesuccinate) for Injection

  Teva Receives Approval For SYNRIBOTM (Omacetaxine Mepesuccinate) for

Treats Chronic Myeloid Leukemia (CML) in Patients Who Have Become Resistant to
           or Intolerant of Two of More Tyrosine Kinase Inhibitors

Protein Synthesis Inhibitor Provides New Treatment Option for CML Patients who
                            Fail Prior TKI Therapy

Business Wire

JERUSALEM -- October 26, 2012

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that the U.S.
Food and Drug Administration (FDA) approved SYNRIBO (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.

  *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

Administered subcutaneously, SYNRIBO  will be  dosed 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 Philadelphiachromosome 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.


  *Serious adverse reactions, including myelosuppression, bleeding, and
    hyperglycemia, have been associated with SYNRIBO. Some reactions, such as
    myelosuppression and cerebral hemorrhage, have been fatal. Patients should
    be monitored closely for these reactions. Consider dose modifications for
  *Women should be advised to avoid becoming pregnant while using SYNRIBO
  *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


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.

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

The following discussion and analysis contains forward-looking statements,
which express the current beliefs and expectations of management. Such
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or contribute to such differences include risks relating to: our ability to
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the introduction of competing generic equivalents and due to increased
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Teva Pharmaceutical Industries Ltd.
Kevin C. Mannix
United States
Joseph Marczely
United States
Tomer Amitai
972 (3) 926-7656
Hadar Vismunski-Weinberg
972 (3) 926-7687
Denise Bradley
United States
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