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| [June 29, 2012] |
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Teva Announces Progress of Biologic Investigational Drugs Evaluated to Treat Neutropenia in Breast Cancer Patients Undergoing Chemotherapy
JERUSALEM --(Business Wire)--
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today the
presentation of clinical results for its biologic oncology candidates,
lipegfilgrastim and balugrastim, at the Multinational Association of
Supportive Care in Cancer (MASCC)/International Society of Oral Oncology
(ISOO) 2012 International Symposium on Supportive Care in Cancer being
held in New York June 28-30.
Lipegfilgrastim and balugrastim are long-acting granulocyte
colony-stimulating factors (G-CSF) being evaluated for their ability to
reduce the duration of severe neutropenia in breast cancer patients
undergoing chemotherapy. Neutropenia is a condition in which the number
of white blood cells is decreased, leaving patients more susceptible to
potentially life-threatening bacterial infections.
Both product candidates have completed phase III clinical trials. In
both phase III breast cancer studies the primary endpoint was achieved,
demonstrating reduction in the duration of severe neutropenia (DSN) in
cycle 1, comparable to pegfilgrastim results in both efficacy and safety
measures. Additional data from the phase I, II and III clinical studies
of these products, will be presented at the MASCC/ISOO symposium in both
oral and poster presentations
"Teva is committed to advancing these investigational biologic drugs,
which are the most advanced of several biologic products that we have in
development," said Dr. Michael Hayden, President of Global R&D and Chief
Scientific Officer for Teva Pharmaceutical Industries Ltd. "Biologics
constitute one of the fastest growing segments of the global
pharmaceutical market, aimed at offering safe and effective approaches
for patients with few therapeutic options."
About G-CSF
Granulocyte colony-stimulating factor (G-CSF) is a naturally occurring
hormone that is produced by the body to stimulate the bone marrow to
produce neutrophils, a type of white blood cell that helps the immune
system fight infection. Chemotherapy can damage the body's ability to
produce neutrophils, thereby causing neutropenia, an abnormally low
number of neutrophils. A common side effect of chemotherapy, neutropenia
makes patients prone to infection and sepsis. A recombinant form of
G-CSF (known as a biologic) is used to treat cancer patients with
neutropenia in order to stimulate the bone marrow to produce more white
blood cells.
About Lipegfilgrastim and Balugrastim
Lipegfilgrastim is a glycopegylated, recombinant form of G-CSF.
Pegylation extends the half-life of the drug so that less frequent
dosing is required compared with nonpegylated G-CSF. Balugrastim is a
recombinant G-CSF fused to human albumin. Both lipegfilgrastim and
balugrastim were designed to stimulate the bone marrow to produce white
blood cells to reduce the duration of severe neutropenia, but have
different mechanisms for achieving the longer half life in the blood.
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.
Teva's Safe Harbor Statement under the U.S. Private Securities
Litigation Reform Act of 1995:
This release contains forward-looking statements, which express the
current beliefs and expectations of management. Such statements 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 innovative orally-administered alternatives, as well as
from potential generic equivalents), competition for our generic
products (including from other pharmaceutical companies and as a result
of increased governmental pricing pressures), competition for our
specialty pharmaceutical businesses, our ability to achieve expected
results through our innovative R&D efforts, the effectiveness of our
patents and other protections for innovative products, decreasing
opportunities to obtain U.S. market exclusivity for significant new
generic products, our ability to identify, consummate and successfully
integrate acquisitions (including the acquisition of Cephalon), the
effects of increased leverage as a result of the acquisition of
Cephalon, the extent to which any manufacturing or quality control
problems damage our reputation for high quality production and require
costly remediation, our potential exposure to product liability claims
to the extent not covered by insurance, increased government scrutiny in
both the U.S. and Europe of our agreements with brand companies,
potential liability for sales of generic products prior to a final
resolution of outstanding patent litigation, including that relating to
the generic version of Protonix®, our exposure to currency fluctuations
and restrictions as well as credit risks, the effects of reforms in
healthcare regulation and pharmaceutical pricing and reimbursement, any
failures to comply with complex Medicare and Medicaid reporting and
payment obligations, governmental investigations into sales and
marketing practices (particularly for our specialty pharmaceutical
products), uncertainties surrounding the legislative and regulatory
pathway for the registration and approval of biotechnology-based
products, 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 our
information technology systems that adversely affect our complex
manufacturing processes, any failure to retain key personnel (including
Cephalon employees) or to attract additional executive and managerial
talent, the impact of continuing consolidation of our distributors and
customers, variations in patent laws that may adversely affect our
ability to manufacture our products in the most efficient manner,
potentially significant impairments of intangible assets and goodwill,
potential increases in tax liabilities, the termination or expiration of
governmental programs or tax benefits, environmental risks and other
factors that are discussed in our Annual Report on Form 20-F for the
year ended December 31, 2011 and in our other filings with the U.S.
Securities and Exchange Commission.

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