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Tuesday, June 28, 2005
 
[ biotech news ] Teva and Active Biotech Announce the Submission of an IND to the FDA

Teva and Active Biotech Announce the Submission of an IND to the FDA
for Laquinimod, an Oral Product for the Treatment of Relapsing MS

JERUSALEM & LUND, Sweden
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active
Biotech AB (Stockholm: ACTI.ST) announced today the submission of an
investigational new drug application (IND) to the U.S. Food and Drug
Administration (FDA) to initiate a clinical trial in the U.S. with
laquinimod to assess drug-drug interaction. Based on the results of
this study and of the ongoing phase IIb study in Europe (see below),
the phase III clinical program to confirm the efficacy and safety of
laquinimod in relapsing forms of MS, is planned to start in 2006.

Laquinimod is a novel orally administered immunomodulatory
substance, developed by Active Biotech and recently licensed to
Teva.

"I am pleased to report on this significant milestone," said Israel
Makov, President and CEO of Teva. "This IND filing is an important
step towards the initiation of pivotal studies with laquinimod
which, along with Teva's development of an oral form of Copaxone(R),
enhance the likelihood that Teva will be the first to market an oral
treatment. This further demonstrates our commitment to developing
new and improved therapies for multiple sclerosis patients in order
to help treat their disease and improve their quality of life".

"We are very pleased to see how Teva's development program is
diligently progressing towards starting phase III studies in the
U.S. and Europe," said Sven Andreasson, President & CEO of Active
Biotech. "Laquinimod has a profile that meets the need for a safe
and efficacious oral MS drug suitable for long term treatment."

Laquinimod has the potential to be the first orally-administered
disease modifying treatment for multiple sclerosis, both as a single
agent therapy and in combination with Copaxone(R), Teva's well-
established and leading product on the market today.

A double-blind, placebo-controlled multi center phase IIb clinical
study is currently on-going in several European countries, in which
the effects of laquinimod, administered orally, once-daily, at dose
levels of 0.3 and 0.6 mg/day, are compared to those of placebo over
9 months of treatment.

About laquinimod

Laquinimod is a novel immunomodulatory substance developed as an
orally bio-available disease modifying treatment of MS. Laquinimod
is the lead candidate drug identified from Active Biotech's SAIK
research program, in which the safety/activity ratio has been
optimized.

In a completed randomized, double-blind, placebo-controlled, multi-
center phase II trial, 209 patients received either laquinimod, at
dose levels of 0.1 or 0.3mg/day, or placebo, orally, once daily for
24 weeks. Laquinimod, at the dose of 0.3mg/day, reduced disease
activity (as measured by MRI) by 44%. In a sub-group of patients
with active MRI brain lesions prior to treatment initiation, the
same dose of laquinimod reduced disease activity by 52%. In this
study, laquinimod demonstrated a very favorable safety profile,
suitable for long-term treatment (Neurology 2005; vol 64, No. 6 p
987).

About Multiple Sclerosis (MS)

Multiple sclerosis (MS) is a chronic, progressive disease of the
central nervous system. It is the most common neurological disease
causing disability in young adults. It has been described as an
autoimmune disease because it is one of many diseases in which the
immune system attacks healthy areas of the body as if they were
foreign. In MS, these attacks are aimed at the central nervous
system. The central nervous system is made up of nerves covered by a
substance called myelin, which is similar to insulation protecting
electrical wires because it surrounds and protects nerve fibers.
When myelin or the nerve fiber is destroyed or damaged, the nerves
cannot send electrical impulses to and from the brain, causing the
onset of MS symptoms.

About Teva:

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is
among the top 20 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%
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.

About Active Biotech

Active Biotech AB is a biotechnology company focusing on research
and development of pharmaceuticals. Active Biotech has a strong R&D
portfolio with pipeline products focused on autoimmune/inflammatory
diseases and cancer. Its most advanced projects are laquinimod, an
orally administered small molecule with unique immunomodulatory
properties for the treatment of multiple sclerosis, as well as
ANYARA for use in cancer immunotherapy with the primary indication
non-small cell lung cancer. Further key projects in clinical
development comprise the three orally administered compounds TASQ
for prostate cancer 57-57 for SLE and RhuDex(R) for RA.

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 Teva'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 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 or license
their own generic products (so called "authorized generics") or
successfully extend the exclusivity period of their branded
products, the effects of competition on Copaxone(R) sales, Teva's
ability to rapidly integrate the operations of acquired businesses,
including its acquisition of Sicor Inc., regulatory changes that may
prevent Teva from exploiting exclusivity periods, potential
liability for sales of generic products prior to completion of
appellate litigation, including that relating to Neurontin, 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, European Medicines
Association and other regulatory authority approvals, the regulatory
environment and changes in the health policies and structure of
various countries, Teva's ability to successfully identify,
consummate and integrate acquisitions, exposure to product liability
claims, dependence on patent and other protections for innovative
products, significant operations outside the United States that may
be adversely affected by terrorism or major hostilities,
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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