Teva Gains Recommendation for Approval from FDA Advisory Committees for VANTRELA™ ER (hydrocodone bitartrate) Extended-Rele...
07 Juin 2016 - 9:33PM
Business Wire
Committees voted that if approved, VANTRELA ER
should be labeled as an abuse-deterrent product by the oral, nasal,
and intravenous routes of abuse
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.
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.
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Teva Pharmaceutical Industries Ltd.IR Contacts:Kevin C.
Mannix, United States, (215) 591-8912Ran Meir, United
States, (215) 591-3033Tomer Amitai, Israel, 972 (3)
926-7656orPR Contacts:Iris Beck Codner, Israel, 972 (3)
926-7687Denise Bradley, United States, (215)
591-8974Nancy Leone, United States, (215) 284-0213
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