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Teva Reports Top-Line Results from Second Phase III Study of Armodafinil (NUVIGIL®) in Patients with Major Depression

  Teva Reports Top-Line Results from Second Phase III Study of Armodafinil
  (NUVIGIL®) in Patients with Major Depression Associated with Bipolar 1
  Disorder

-Following first, positive trial, second trial fails to demonstrate efficacy
in meeting primary and secondary endpoints

-Teva remains committed to clinical development program with third, ongoing
phase III and open-label extension trials

Business Wire

JERUSALEM -- January 23, 2013

Teva Pharmaceutical Industries Ltd. today announced top-line results of its
Phase III clinical program for armodafinil (NUVIGIL^®) as adjunct therapy in
adults with major depression associated with bipolar 1 disorder. While study
3072 demonstrated a numerical improvement, it did not reach statistical
significance in meeting its primary endpoint -- to determine whether
armodafinil treatment, at a dosage of 150 mg per day, is more effective than
placebo as adjunct therapy to mood stabilizers and/or atypical antipsychotics.
This is the second of three, Phase III studies; results of the first pivotal
study 3071 announced in May, 2012 were positive (P=0.0097). Study 3073 and
open-label extension study 3074 are ongoing; results are expected for study
3073 later this year.

“While we are disappointed that the second study did not reach statistical
significance, we are firmly committed to continuing with the third, Phase III
trial based on the promising results of the first study, the trend seen in the
second, and comparable safety results between the two studies. Bipolar 1
disorder is a complex disease where there remains a significant unmet patient
need to successfully treat associated depressive episodes,” said Michael
Hayden, M.D., president of Global R&D and Chief Scientific Officer. “We
believe that armodafinil may have a unique mechanism of action in patients
with depression associated with bipolar 1 disorder, and we will continue to
study it as adjunct therapy in adults with this debilitating disease. At Teva,
we are dedicated to advancing the science in serious neuropsychiatric
conditions, such as this.”

Bipolar disorder is among the top 20 most severely disabling disorders.^i
Bipolar 1 disorder is defined by manic or mixed episodes that last at least a
week in which an individual feels abnormally euphoric, optimistic, and
energetic, and can be so severe as to require hospitalization, followed by
depressive episodes typically lasting at least two weeks. The depressive
episodes of bipolar 1 disorder can be so severe that the person cannot
function normally at work, school, or home^ii.

About Armodafinil

Armodafinil is currently available 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 1 disorder.

IMPORTANT SAFETY INFORMATION

The NUVIGIL (armodafinil) label includes a bolded 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 $18.3 billion in net revenues in 2011.

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, including statements relating to the results of the GALA phase III
trial and the potential efficacy or future market or marketability of
glatiramer acetate 40 mg/1 ml. Following further analysis, Teva's
interpretation of the results could differ materially depending on a number of
factors, and we caution investors not to place undue reliance on the
forward-looking statements contained in this press release as there can be no
guarantee that the results from the phase III trial discussed in this press
release will be confirmed upon full analysis of the results of the trial and
additional information relating to the safety, efficacy or tolerability of
glatiramer acetate 40 mg/1 ml may be discovered upon further analysis of data
from the phase III trial. Even if the results described in this release are
confirmed upon full analysis of the GALA study, we cannot guarantee that
glatiramer acetate 40 mg/1 ml will be approved for marketing in a timely
manner, if at all, by regulatory authorities in the EU or in the U.S.
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 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 (including the
acquisition of Cephalon), the effects of increased leverage as a result of the
acquisition of Cephalon, 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, including that relating to the generic version of
Protonix®, 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 pathway for the registration and approval of
biotechnology-based products, adverse effects of political or economical
instability, 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 (including Cephalon employees)
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, 2011 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.

^i World Health Organizations. (2004).The Global Burden of Disease. Retrieved
January 1, 2013 from
http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf.

^ii National Institute of Mental Health. (2009). Bipolar disorder. (No.
09-3679). Retrieved January 1, 2013 from
http://www.nimh.nih.gov/health/publications/bipolar-disorder/nimh-bipolar-adults.pdf

Contact:

Teva Pharmaceutical Industries Ltd.
IR:
Kevin C. Mannix, 215-591-8912
United States
or
Tomer Amitai, 972 (3) 926-7656
Israel
or
PR:
Hadar Vismunski-Weinberg, 972 (3) 926-7687
Israel
or
Denise Bradley, 215-591-8974
United States
 
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