This study was the third of three, Phase III studies, all of which
demonstrated improvements in patient response. However, based on an
evaluation of the totality of results, Teva will not proceed with
regulatory filings for armodafinil for the treatment of major depression
associated with bipolar I disorder. There is no material impact to the
Company.
“While this study demonstrated a numerical improvement, we are
disappointed that armodafinil did not reach statistical significance.
Teva remains committed to advancing science in serious conditions
affecting the central nervous system.“ Said Michael Hayden, M.D., Ph.D.,
President of Global R&D and Chief Scientific Officer at Teva. “We will
continue to focus on our current NUVIGIL® indications and we
remain committed to improving wakefulness in adult patients with
excessive sleepiness associated with shift work disorder, obstructive
sleep apnea or narcolepsy.”
About Armodafinil
Armodafinil is currently available in the United States as NUVIGIL®,
a prescription medicine indicated to improve wakefulness in adults who
experience excessive sleepiness (ES) due to obstructive sleep apnea
(OSA), shift work disorder (SWD), or narcolepsy. NUVIGIL® is
not approved for use in treating major depression associated with
bipolar I disorder.
IMPORTANT SAFETY INFORMATION
The NUVIGIL® (armodafinil) label includes a warning for
serious or life-threatening rash, including Stevens-Johnson Syndrome,
requiring hospitalization and discontinuation of treatment, that has
been reported in adults in association with the use of modafinil and
armodafinil and in children in association with the use of modafinil, a
racemic mixture of S and R modafinil (the latter is armodafinil, the
active ingredient in NUVIGIL®). NUVIGIL® is not
approved for use in pediatric patients for any indication.
In controlled trials in adults administered NUVIGIL®,
psychiatric symptoms resulting in treatment discontinuation were
anxiety, agitation, nervousness, and irritability. Caution should be
exercised when NUVIGIL® is given to patients with a history
of psychosis, depression, or mania. Consider discontinuing NUVIGIL®
if psychiatric symptoms develop.
The most common adverse events in controlled clinical trials (five
percent or greater) were headache, nausea, dizziness, and insomnia. Full
prescribing information for NUVIGIL® is available at www.NUVIGIL.com.
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,
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 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 economical
instability, corruption, major hostilities or acts of terrorism on our
significant worldwide operations, interruptions in our supply chain or
problems with our information technology systems that adversely affect
our complex manufacturing processes, any failure to retain key personnel
or to attract additional executive and managerial talent, the impact of
continuing consolidation of our distributors and customers, variations
in patent laws that may adversely affect our ability to manufacture our
products in the most 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.
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
Kevin C. Mannix
United
States
215-591-8912
or
Ran Meir
United States
215-591-3033
or
Tomer
Amitai
Israel
972 (3) 926-7656
or
PR:
Iris
Beck Codner
Israel
972 (3) 926-7246
or
Denise
Bradley
United States
215-591-8974