Teva Receives Approval For SYNRIBOTM (Omacetaxine Mepesuccinate) for Injection

  Teva Receives Approval For SYNRIBOTM (Omacetaxine Mepesuccinate) for
  Injection

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
    lymphopenia

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.

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 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.

ABOUT SYNRIBO

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.

IMPORTANT SAFETY INFORMATION

  *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
    toxicities
  *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
    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 1,300 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.

ABOUT TEVA ONCOLOGY

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
statements 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 from
the introduction of competing generic equivalents and due to increased
governmental pricing pressures, the effects of competition on sales of our
innovative medicines, especially Copaxone® (including competition from
innovative orally-administered alternatives as well as from potential generic
equivalents), potential liability for sales of generic medicines prior to a
final resolution of outstanding patent litigation, including that relating to
our generic version of Protonix®, the extent to which we may obtain U.S.
market exclusivity for certain of our new generic medicines, the extent to
which any manufacturing or quality control problems damage our reputation for
high quality production and require costly remediation, our ability to
identify, consummate and successfully integrate acquisitions (including the
acquisition of Cephalon), our ability to achieve expected results through our
innovative R&D efforts, dependence on the effectiveness of our patents and
other protections for innovative medicines, intense competition in our
specialty pharmaceutical businesses, uncertainties surrounding the legislative
and regulatory pathway for the registration and approval of
biotechnology-based medicines, our potential exposure to product liability
claims to the extent not covered by insurance, any failures to comply with the
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to currency fluctuations and restrictions as well as credit risks, the effects
of reforms in healthcare regulation and pharmaceutical pricing and
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resulting from challenges to our intercompany arrangements, the termination or
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personnel or to attract additional executive and managerial talent,
environmental risks, and other factors that are discussed in our Annual Report
on Form 20-F for the year ended December 31, 2011, in this report and in our
other filings with the U.S. Securities and Exchange Commission ("SEC").
Forward-looking statements speak only as of the date on which they are made,
and we undertake no obligation to update any forward-looking statements or
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any additional disclosures we make in our reports to the SEC on Form 6-K. Also
note that we provide a cautionary discussion of risks and uncertainties under
"Risk Factors" in our Annual Report on Form 20-F for the year ended December
31, 2011. These are factors that we believe could cause our actual results to
differ materially from expected results. Other factors besides those listed
could also adversely affect us. This discussion is provided as permitted by
the Private Securities Litigation Reform Act of 1995.

Contact:

Teva Pharmaceutical Industries Ltd.
IR:
Kevin C. Mannix
United States
215-591-8912
or
Joseph Marczely
United States
267-468-4281
or
Tomer Amitai
Israel
972 (3) 926-7656
or
PR:
Hadar Vismunski-Weinberg
Israel
972 (3) 926-7687
or
Denise Bradley
United States
215-591-8974
 
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