FDA Approves Teva’s TREANDA® (bendamustine HCI) Injection, a New Liquid Formulation

  FDA Approves Teva’s TREANDA® (bendamustine HCI) Injection, a New Liquid
  Formulation

              New Formulation Eliminates Need for Reconstitution

Business Wire

JERUSALEM -- September 17, 2013

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced that the U.S.
Food and Drug Administration (FDA) approved TREANDA (bendamustine HCI)
Injection, a new formulation of the currently approved TREANDA (bendamustine
HCI) for Injection. TREANDA is indicated for use in patients with indolent
B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six
months of treatment with rituximab or a rituximab-containing regimen, and in
patients with chronic lymphocytic leukemia (CLL). The efficacy of TREANDA in
CLL relative to first line therapies other than chlorambucil has not been
established.

This new liquid formulation removes the step of reconstituting lyophilized
powder with sterile water prior to adding the medicine to the dilutent and
administering to a patient.

“By eliminating the need for reconstitution, a step is removed making dose
preparation fast and convenient for healthcare professionals,” said Jim
Koeller, M.S., Professor, University of Texas at Austin, College of Pharmacy.

Teva was assigned a Priority Review designation for the supplemental New Drug
Application (sNDA) for the new liquid formulation of TREANDA, which was
submitted to the FDA on March 8, 2013. The FDA designates Priority Review for
drug applications that would be significant improvements in the safety or
effectiveness of the treatment, diagnosis, or prevention of serious conditions
when compared to standard applications.

“Teva is committed to continuously improving our medicines to deliver greater
value to all stakeholders,” said Bill Campbell, Vice President and General
Manager, Teva Oncology. “With this new liquid formulation of TREANDA, we are
building on the legacy of TREANDA, which has played a valuable role since 2008
in the treatment of patients with CLL or indolent B-cell NHL that has
progressed.”

Indications

TREANDA is indicated for the treatment of patients with chronic lymphocytic
leukemia (CLL). Efficacy relative to first-line therapies other than
chlorambucil has not been established.

TREANDA is indicated for the treatment of patients with indolent B-cell
non-Hodgkin lymphoma (NHL) that has progressed during or within six months of
treatment with rituximab or a rituximab-containing regimen.

Important Safety Information

  *Allergic Reactions: Patients with a known allergic response to
    bendamustine should not take TREANDA.
  *Serious Side Effects: TREANDA may cause serious side effects, including
    low blood cell counts, infections, unexpected responses to TREANDA when
    placed in your blood, sudden and severe allergic responses, kidney failure
    due to fast breakdown of cancer cells, other cancers, and leaking of
    TREANDA out of your vein and into your surrounding skin. Some of these
    side effects, such as low blood counts, infections, and severe allergic
    skin responses (when TREANDA was given with allopurinol and other
    medications known to cause severe allergic skin responses), have caused
    death. Tell your doctor right away if you have any of these side effects.
  *Changes in Therapy: Some serious side effects may require changes in
    therapy, such as lowering the amount of TREANDA given, stopping the use of
    TREANDA, or waiting longer than expected between doses of TREANDA.
  *Pregnancy: Women should avoid becoming pregnant while using TREANDA
    because it may cause fetal harm if you take TREANDA while pregnant.
  *Most Common Side Effects: The most common non-blood-related side effects
    associated with TREANDA (occurring in ≥15% of patients) are nausea,
    fatigue, vomiting, diarrhea, fever, constipation, loss of appetite, cough,
    headache, weight loss, difficulty breathing, rash, and mouth irritation.
    The most common blood-related side effects associated with TREANDA
    (frequency ≥15%) are decreased number of three different types of white
    blood cells (infection-fighting cells), low red blood cells
    (oxygen-carrying cells), and low platelets (blood-clotting cells).

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 TREANDA (bendamustine HCI) Injection

TREANDA was approved by the FDA for the treatment of chronic lymphocytic
leukemia (CLL) in March 2008. Efficacy relative to first line therapies other
than chlorambucil has not been established. TREANDA received its second
approval in October 2008 for the treatment of patients with indolent B-cell
non-Hodgkin lymphoma (NHL) that has progressed during or within six months of
treatment with rituximab or a rituximab-containing regimen.

TREANDA has a unique chemical structure that is synthesized to combine an
alkylating group and a purine-like benzimidazole component. Though the exact
mechanism of action of TREANDA remains unknown, bendamustine is active against
both quiescent and dividing cells. Preclinical studies suggest that TREANDA
may lead to cell death by a process known as apoptosis (programmed cell death)
as well as by an alternate cell death pathway which disrupts normal cell
division known as mitotic catastrophe (a non-apoptotic pathway).

About Chronic Lymphocytic Leukemia (CLL)

Chronic lymphocytic leukemia (CLL) is one of four main types of leukemia. CLL
begins with a change to a single white blood cell, or lymphocyte, of the bone
marrow. Over time, the CLL cells multiply, replacing normal lymphocytes in the
marrow and lymph nodes. As the amount of lymphocytes increases in the blood
and bone marrow, there is less room for healthy white and red blood cells as
well as platelets, which may result in infection, anemia and bleeding.

About Indolent Non-Hodgkin lymphoma (NHL)

Non-Hodgkin lymphoma (NHL) is a disease in which cancer cells form in the
lymphatic tissue in the body. Because lymph tissue is found throughout the
body, NHL can begin almost anywhere in the body and spread to almost any
tissue or organ. There are approximately 60 different types of NHL, which are
formed from either B-cells or T-cells. The majority of non-Hodgkin lymphomas
(80 to 90 percent) are formed by B-cells. Types of NHL are generally divided
into two categories–indolent and aggressive.

Indolent non-Hodgkin lymphomas (iNHL) are slow-growing lymphomas. The median
survival of patients with indolent lymphoma is approximately 10 years.
Indolent lymphomas are often responsive to therapy but usually relapse.

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 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 $20.3 billion in net revenues in 2012.

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, including our ability to
develop, manufacture, market and sell biopharmaceutical products, competition
for our innovative products, especially COPAXONE® (including competition from
innovative orally-administered alternatives, as well as from potential
purported 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 specialty,
including 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, the effects of
increased leverage as a result of recent acquisitions, 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, 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 pathways for the registration and
approval of biotechnology based products, adverse effects of political or
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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, 2012 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 the Company undertakes no obligation to update or
revise any forward looking statement, whether as a result of new information,
future events or otherwise.

Contact:

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