Source: Marketwire
http://www.marketwire.com/mw/release_printer_friendly?release_id=75000&ca
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AGILECT(R) Improved Parkinson's Disease Symptoms Without Worsening
Cognitive and Behavioral Symptoms
Data Presented at Mental Dysfunction in Parkinson's Disease Conference

KANSAS CITY, MO and TEANECK, NJ -- (MARKET WIRE) -- 10/27/2004 --
AGILECT® (rasagiline mesylate), 1 mg dosed once daily, improved symptoms
of Parkinson's disease (PD), including motor fluctuations, without
significantly increasing the occurrence of cognitive and behavioral
adverse events (CBAE) in early and in moderate-to-advanced PD patients.
Data from two pivotal studies were re-analyzed and demonstrated a low
incidence of this type of adverse event with AGILECT® versus placebo.
These results were presented at the Mental Dysfunction in Parkinson's
Disease Conference in Salzburg, Austria.

Lawrence Elmer, M.D., Ph.D., director of the Center for Neurological
Disorders and the Parkinson's Disease and Movement Disorder Program at
the Medical College of Ohio presented the data on behalf of the Parkinson
Study Group. "These results support the overall clinical utility we have
seen with rasagiline in development trials," said Dr. Elmer. "Cognitive
and behavioral issues can be common deterrents to effective management of
Parkinson's disease. The low occurrence of cognitive and behavioral
adverse events with rasagiline is encouraging."

Teva Neuroscience, Inc., and Eisai Inc. will co-promote AGILECT® in the
United States, once approved by the FDA, as part of a long-term strategic
alliance between Teva Pharmaceutical Industries Ltd. and Eisai Co., Ltd.

The analysis presented by Dr. Elmer evaluated the occurrence of CBAE and
the change from baseline in the Unified Parkinson's Disease Rating Scale
(UPDRS) Part I mental subscores from both a monotherapy and an adjunct
therapy study. Part I of the UPDRS is the mental subscore that rates
patients' intellectual impairment, thought disorders, depression and
motivation/initiative.

The data demonstrated a low incidence of CBAE with AGILECT® (rasagiline
mesylate), compared to placebo. The CBAE of hallucinations, confusion,
depression, somnolence and other sleep disorders in the subjects treated
with AGILECT® were few and did not exceed the incidence seen in subjects
receiving placebo by more than 3 percent. In addition, UPDRS Part I
mental subscores showed no significant difference in the changes from
baseline between AGILECT® and placebo.

The data were taken from two pivotal studies that evaluated the safety
and efficacy of AGILECT®. The two studies, called TEMPO* and PRESTO*,
included over 800 patients, and were conducted by the Parkinson Study
Group. The TEMPO monotherapy trial enrolled patients with early-stage PD
who were not receiving dopaminergic therapy. The PRESTO adjunct therapy
trial included patients with moderate-to-advanced PD who were receiving
optimized doses of levodopa, as well as other PD medications such as
dopamine agonists and COMT inhibitors, and were still experiencing motor
fluctuations.

"Rasagiline, given once daily, improved the patients' PD symptoms, but
did not have observed effects on their mental functioning, behavior or
mood," said Dr. Elmer. "This analysis of the clinical trials data
suggests rasagiline may improve symptoms in PD without increasing
cognitive and behavioral adverse events."

AGILECT® was well tolerated in both trials. In TEMPO, adverse events seen
more frequently in the AGILECT® 1 mg group (frequency greater than 3
percent on treatment and at least 2 percent greater than placebo) were
headache, dyspepsia, depression, flu syndrome and rash. In PRESTO,
adverse events seen more frequently in the AGILECT®1 mg group (frequency
greater than or equal to 6 percent on treatment and at least 2 percent
greater than placebo) were dyskinesia, accidental injury, nausea, weight
loss, constipation, postural hypotension, arthralgia, vomiting, dry mouth
and rash.

Parkinson's disease is a degenerative disorder of the brain. Symptoms can
include tremor, stiffness, slowness of movement and impaired balance. An
estimated one million Americans have PD, which usually affects people
over the age of 50.

The Parkinson Study Group (www.Parkinson-Study-Group.org) is a
non-profit, cooperative group of PD experts from medical centers in the
United States and Canada who are dedicated to improving treatment for
persons affected by PD.

AGILECT® (rasagiline mesylate) is a novel, potent, second-generation,
selective, irreversible monoamine oxidase type-B (MAO-B) inhibitor that
blocks the breakdown of dopamine, a substance in the brain needed to
facilitate movement. A new drug application for AGILECT® for the
treatment of PD was submitted to the U.S. Food and Drug Administration
(FDA) Sept. 5, 2003. Indications are being sought for once-daily AGILECT®
as a monotherapy in early PD and as an adjunct to levodopa in moderate to
advanced disease.

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), headquartered in
Israel, is among the top 25 pharmaceutical companies and among the
largest generic pharmaceutical companies in the world. The company
develops, manufactures and markets generic and innovative human
pharmaceuticals and active pharmaceutical ingredients. Close to 90
percent of Teva's sales are in North America and Europe. Teva's
innovative R&D focuses on developing novel drugs for diseases of the
central nervous system.

Teva Neuroscience, Inc. is a subsidiary of Teva Pharmaceutical Industries
Ltd.

Eisai Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd., a
research-based human health care (hhc) company that discovers, develops
and markets products in more than 30 countries. Established in 1995,
Eisai Inc. began marketing its first product in the United States in 1997
and has rapidly grown to become an integrated pharmaceutical business
with more than $1.7 billion in sales for fiscal year 2003 (year ending
March 31, 2004). Eisai focuses its efforts in four therapeutic areas:
neurology, gastrointestinal disorders, oncology and acute care.

The development of rasagiline is part of a long-term alliance for
co-development in Parkinson's disease and European marketing between Teva
and H. Lundbeck A/S. Teva and H. Lundbeck A/S will co-promote the product
in Europe, once approved there. Rasagiline was developed cooperatively by
Teva and the Technion -- Israel Institute of Technology.

Teva submitted an application to market rasagiline as a treatment for PD
with the European Agency for Evaluation of Medicinal Products (EMEA) on
Oct. 10, 2003. Rasagiline also was submitted for review in Canada Sept.
24, 2003, where, upon approval, it will be marketed by Teva Neuroscience,
Inc.

AGILECT® (rasagiline mesylate) is a registered trademark of Teva
Pharmaceutical Industries Ltd.

* TEMPO TVP-1012 in Early Monotherapy for Parkinson's Disease Outpatients


* PRESTO Parkinson's Rasagiline: Efficacy and Safety in the Treatment of
"Off"

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 current expectations and involve a number of known and unknown risks
and uncertainties that could cause Teva's and Eisai's 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 Teva's and Eisai's ability to successfully develop
and commercialize additional pharmaceutical products, the introduction of
competitive generic products, the impact of competition from brand-name
companies that sell their own generic products or successfully extend the
exclusivity period of their branded products, Teva's or Eisai's ability
to rapidly integrate the operations of acquired businesses, including
Teva's recent acquisition of Sicor Inc., the availability of product
liability coverage in the current insurance market, the impact of
pharmaceutical industry regulation and pending legislation that could
affect the pharmaceutical industry, the difficulty of predicting U.S.
Food and Drug Administration and other regulatory authority approvals,
the regulatory environment and changes in the health policies and
structure of various countries, acceptance and demand for new
pharmaceutical products and new therapies, uncertainties regarding market
acceptance of innovative products newly launched, currently being sold or
in development, the impact of restructuring of clients, reliance on
strategic alliances, exposure to product liability claims, dependence on
patent and other protections for innovative products, fluctuations in
currency, exchange and interest rates, operating results and other
factors that are discussed in Teva's Annual Report on Form 20-F and its
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 publicly or
revise any forward-looking statement, whether as a result of new
information, future developments or otherwise.


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Contacts:
Pat Donohue
Eisai Inc.
(201) 287-2978
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Chris Yonke
Fleishman-Hillard Inc.
(816) 512-2430
[log in to unmask]

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