Teva Announces Launch of Generic Gleevec® Tablets in the United States

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today
announced the launch of the generic equivalent to Gleevec^®1(imatinib
mesylate) tablets,100 mg and 400 mg, in the United States for multiple
indications approved by the FDA.
Teva remains committed to strengthening its generics business with
continued investment in new and diverse, high quality products. With
nearly 375 generic medicines available, Teva has one of the largest
portfolios of FDA-approved generic products on the market. The addition
of this product to Teva’s oncology portfolio allows Teva to continue to
grow in this therapeutic area.
Imatinib mesylate tablets had annual sales of approximately $2.42
billion in the United States, according to IMS data as of May 2016.
About Imatinib Mesylate Tablets
Imatinib mesylate tablets are indicated for: newly diagnosed adult and
pediatric patients with Philadelphia chromosome positive chronic myeloid
leukemia (Ph+ CML) in chronic phase; patients with Ph+ CML in blast
crisis, accelerated phase, or in chronic phase after failure of
interferon-alpha therapy; adult patients with relapsed or refractory
Philadelphia chromosome positive acute lymphoblastic leukemia; adult
patients with myelodysplastic/myeloproliferative diseases associated
with PDGFR (platelet-derived growth factor receptor) gene
re-arrangements; adult patients with aggressive systemic mastocytosis
without the D816V c-Kit mutation or with c-Kit mutational status
unknown; adult patients with hypereosinophilic syndrome (HES) and/or
chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion
kinase (mutational analysis or FISH demonstration of CHIC2 allele
deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα
fusion kinase negative or unknown; adult patients with unresectable,
recurrent and/or metastatic dermatofibrosarcoma protuberans; and
adjuvant treatment of adult patients following complete gross resection
of Kit (CD117) positive gastrointestinal stromal tumors (GIST) .
Important Safety Information
Serious
adverse reactions associated with imatinib mesylate treatment include:
edema and severe fluid retention; anemia, neutropenia, and
thrombocytopenia; severe congestive heart failure and left ventricular
dysfunction; severe hepatotoxicity, including fatalities; Grade 3/4
hemorrhage in patients with newly diagnosed CML and with GIST;
gastrointestinal perforations, including fatalities; cardiogenic
shock/left ventricular dysfunction in patients with conditions
associated with high eosinophil levels; bullous dermatologic reactions,
including erythema multiforme and Stevens-Johnson syndrome;
hypothyroidism in thyroidectomy patients undergoing levothyroxine
replacement; fetal harm when administered to a pregnant woman; growth
retardation in children and pre-adolescents; and tumor lysis syndrome,
including fatalities.
Reports of motor vehicle accidents have been received in patients
receiving imatinib mesylate. Patients may experience dizziness, blurred
vision or somnolence during treatment with imatinib mesylate. The most
frequently reported adverse reactions (≥ 30%) for imatinib mesylate in
clinical trials were: edema, nausea, vomiting, muscle cramps,
musculoskeletal pain, diarrhea, rash, fatigue, and abdominal pain.
For more information, please see the accompanying Full
Prescribing Information.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by millions of patients every
day. Headquartered in Israel, Teva is the world’s largest generic
medicines producer, leveraging its portfolio of more than 1,000
molecules to produce a wide range of generic products in nearly every
therapeutic area. In specialty medicines, Teva has a world-leading
position in innovative treatments for disorders of the central nervous
system, including pain, as well as a strong portfolio of respiratory
products. Teva integrates its generics and specialty capabilities in its
global research and development division to create new ways of
addressing unmet patient needs by combining drug development
capabilities with devices, services and technologies. Teva’s net
revenues in 2015 amounted to $19.7 billion. For more information, visit www.tevapharm.com.
Teva’s Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
This release contains forward-looking statements, which 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 specialty products, especially Copaxone® (which
faces competition from orally-administered alternatives and a generic
version); our ability to consummate the acquisition of Allergan plc’s
worldwide generic pharmaceuticals business (“Actavis Generics”) and to
realize the anticipated benefits of such acquisition (and the timing of
realizing such benefits); the fact that following the consummation of
the Actavis Generics acquisition, we will be dependent to a much larger
extent than previously on our generic pharmaceutical business; potential
restrictions on our ability to engage in additional transactions or
incur additional indebtedness as a result of the substantial amount of
debt we will incur to finance the Actavis Generics acquisition; the fact
that for a period of time following the consummation of the Actavis
Generics acquisition, we will have significantly less cash on hand than
previously, which could adversely affect our ability to grow; the
possibility of material fines, penalties and other sanctions and other
adverse consequences arising out of our ongoing FCPA investigations and
related matters; our ability to achieve expected results from
investments in our pipeline of specialty and other products; our ability
to identify and successfully bid for suitable acquisition targets or
licensing opportunities, or to consummate and integrate acquisitions;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
increased government scrutiny in both the U.S. and Europe of our patent
settlement agreements; our exposure to currency fluctuations and
restrictions as well as credit risks; the effectiveness of our patents,
confidentiality agreements and other measures to protect the
intellectual property rights of our specialty medicines; the effects of
reforms in healthcare regulation and pharmaceutical pricing,
reimbursement and coverage; competition for our generic products, both
from other pharmaceutical companies and as a result of increased
governmental pricing pressures; governmental investigations into sales
and marketing practices, particularly for our specialty pharmaceutical
products; adverse effects of political or economic instability, major
hostilities or acts of terrorism on our significant worldwide
operations; interruptions in our supply chain or problems with internal
or third-party information technology systems that adversely affect our
complex manufacturing processes; significant disruptions of our
information technology systems or breaches of our data security;
competition for our specialty pharmaceutical businesses from companies
with greater resources and capabilities; the impact of continuing
consolidation of our distributors and customers; decreased opportunities
to obtain U.S. market exclusivity for significant new generic products;
potential liability in the U.S., Europe and other markets for sales of
generic products prior to a final resolution of outstanding patent
litigation; our potential exposure to product liability claims that are
not covered by insurance; any failure to recruit or retain key
personnel, or to attract additional executive and managerial talent; any
failures to comply with complex Medicare and Medicaid reporting and
payment obligations; significant impairment charges relating to
intangible assets, goodwill and property, plant and equipment; the
effects of increased leverage and our resulting reliance on access to
the capital markets; potentially significant increases in tax
liabilities; the effect on our overall effective tax rate of the
termination or expiration of governmental programs or tax benefits, or
of a change in our business; variations in patent laws that may
adversely affect our ability to manufacture our products in the most
efficient manner; environmental risks; and other factors that are
discussed in our Annual Report on Form 20-F for the year ended December
31, 2015 and in our other filings with the U.S. Securities and Exchange
Commission (the “SEC”). Forward-looking statements speak only as of the
date on which they are made and we assume no obligation to update or
revise any forward-looking statements or other information, whether as a
result of new information, future events or otherwise.
¹ GLEEVEC^® is a registered trademark of Novartis
Oncology.