JERUSALEM--(BUSINESS WIRE)--Feb. 25, 2015--
Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) announced today that
the U.S. Food and Drug Administration (FDA) has accepted for review the
New Drug Application (NDA) for the company’s hydrocodone bitartrate
extended-release (ER) tablets formulated with Teva’s proprietary abuse
deterrence technology (CEP-33237). CEP-33237 is an investigational,
12-hour, acetaminophen-free, formulation of extended-release hydrocodone
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.
"Teva is committed to developing innovative approaches to helping
advance responsible pain management and is pleased the FDA is moving
forward in its consideration of CEP-33237,” said Michael Hayden, MD,
PhD, President of Global R&D and Chief Scientific Officer at Teva. "With
positive results from Human Abuse Liability studies in the two most
common routes of hydrocodone abuse, CEP-33237 with potential abuse
deterrence properties, represents a positive step towards responsible
pain management.”
The NDA filing is supported by a clinical program that evaluated the
safety and efficacy of CEP-33237, as well as the abuse potential of
CEP-33237 via the oral and intranasal routes of abuse in Human Abuse
Liability (HAL) studies:
-
Results from the Phase III clinical program for CEP-33237 showed
significant improvement in the treatment of patients’ chronic low back
pain as measured by both weekly average Worst Pain Intensity (WPI) and
weekly Average Pain Intensity (API) scores.
-
In the oral HAL study in nondependent, recreational opioid users,
abuse potential was significantly lower for finely crushed CEP-33237
than for immediate-release (IR) hydrocodone powder based on peak
at-the-moment drug liking. Overall drug liking was also significantly
lower for finely crushed CEP-33237 compared to IR hydrocodone.
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The intranasal HAL study found that in nondependent, recreational
opioid users, abuse potential for finely milled intranasal CEP-33237
was significantly lower based on peak at-the-moment drug liking than
for intranasal IR hydrocodone powder and finely milled intranasal
Zohydro® ER (hydrocodone bitartrate) extended-release
capsules [C-II]* as commercially available at the time the study was
conducted. Overall drug liking was also significantly lower for finely
crushed CEP-33237 compared to IR hydrocodone and Zohydro®
ER.
-
CEP-33237 demonstrated a safety profile in the Phase III study that is
consistent with the known safety profile of hydrocodone and other
opioid analgesic therapies. 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 and dizziness.
“The impact of living with chronic pain can be devastating, affecting
many aspects of daily life,” said Richard Malamut, MD, Vice President of
Global Clinical Development and Therapeutic Area Head of Pain at Teva.
“If approved, CEP-33237 will provide an important treatment option for
people living with chronic pain and healthcare professionals who care
for them.”
*Zohydro® ER is a registered trademark of Zogenix, Inc.
About Chronic Pain
Chronic pain is persistent pain that is not amenable to treatments based
upon specific remedies or to the routine methods of pain control. An
Institute of Medicine (IOM) report estimates that chronic pain affects
millions of American adults, including people who reported having
“severe pain,” “moderate pain,” “joint pain,” “arthritis,” or functional
limitation.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions to 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 2014 amounted to $20.3
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 innovative products, especially Copaxone®
(including competition from orally-administered alternatives, as well as
from potential purported generic equivalents) and our ability to
migrate users to our new 40 mg/mL version; 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 the research and development
efforts invested in our pipeline of specialty and other products; our
ability to reduce operating expenses to the extent and during the
timeframe intended by our cost reduction program; 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; 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 generic products, both from other pharmaceutical
companies and as a result of increased governmental pricing pressures;
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, 2014 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 we assume no obligation to update or revise any
forward-looking statement, whether as a result of new information,
future events or otherwise.
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
Kevin C.
Mannix, 215-591-8912
United States
or
Ran Meir,
215-591-3033
United States
or
Tomer Amitai, 972
(3) 926-7656
Israel
or
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Iris Beck Codner,
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or
Denise Bradley,
215-591-8974
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Nancy Leone,
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