Teva Gains Recommendation for Approval from FDA Advisory Committees for VANTRELA™ ER (hydrocodone bitartrate) Extended-Release Tablets CII Formulated with Proprietary Abuse Deterrence Technology

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that the Anesthetic and Analgesic Drug Products Advisory
Committee and Drug Safety and Risk Management Advisory Committee of the
U.S. Food and Drug Administration (FDA) voted 14 to 3 to recommend
approval of VANTRELA™ ER for the management of pain severe enough to
require daily, around-the-clock, long-term opioid treatment and for
which alternative treatment options are inadequate. VANTRELA ER is an
extended-release formulation of hydrocodone bitartrate with Teva’s
proprietary abuse deterrence technology.
The committees also voted:

• 14 to 3 that if approved, VANTRELA ER should be labeled as an
  abuse-deterrent product by the oral route of abuse.
• 14 to 3 that if approved, VANTRELA ER should be labeled as an
  abuse-deterrent product by the nasal route of abuse.
• 16 to 1 that if approved, VANTRELA ER should be labeled as an
  abuse-deterrent product by the intravenous route of abuse.

“There remains a need for treatment options that help deter potential
abuse while still providing people living with pain access to effective
relief options,” said Michael Hayden, M.D., Ph.D., President of Global
R&D and Chief Scientific Officer at Teva. “We are encouraged by the
outcome of today’s FDA Advisory Committee meeting and support for
labeling as an abuse-deterrent product by the oral, nasal and
intravenous routes of abuse. We believe in the potential of both
VANTRELA ER and our proprietary abuse deterrence technology.”
Based on the committees’ votes, Teva anticipates, if approved, the label
for VANTRELA ER will describe the product’s abuse-deterrent properties
that are expected to reduce, but not totally prevent, abuse of the drug
when the tablets are manipulated. The FDA is not bound by the
recommendations of its advisory committees, but will consider their
guidance during the review of the New Drug Application (NDA) for
VANTRELA ER.
Adverse events reported in five percent or more of hydrocodone-treated
patients during either the titration or double-blind treatment periods
included: nausea, constipation, vomiting, headache, somnolence, itching
and dizziness.
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.
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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
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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
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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
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reforms in healthcare regulation and pharmaceutical pricing,
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from other pharmaceutical companies and as a result of increased
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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
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effects of increased leverage and our resulting reliance on access to
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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.