Early versus Delayed Treatment with Laquinimod Demonstrated Significant Reduction in Risk of Disability Progression – Results

  Early versus Delayed Treatment with Laquinimod Demonstrated Significant
  Reduction in Risk of Disability Progression – Results of Three-Year ALLEGRO
  Study in Relapsing-Remitting Multiple Sclerosis

  *Data presented at the 65th Annual Meeting of the American Academy of
    Neurology (AAN) showed early treatment with laquinimod demonstrated
    significant benefit in terms of slowing disability progression compared to
    delayed treatment
  *36-month data affirmed the safety profile demonstrated in the ALLEGRO
    pivotal clinical trial
  *Additional animal preclinical data demonstrated laquinimod restored
    myelination in the brain and spinal cord

Business Wire

JERUSALEM & LUND, Sweden -- March 21, 2013

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Active Biotech (NASDAQ
OMX NORDIC: ACTI) announced today top-line results from the open-label
extension of the Phase III ALLEGRO study that assessed the progression of
disability and safety of oral laquinimod in early versus delayed-start
relapsing-remitting multiple sclerosis (RRMS) patients. The study compared the
effectiveness of laquinimod in patients who received 36 months (early-start)
versus those who received 24 months of laquinimod treatment (delayed-start).
Laquinimod is an oral, once daily, investigational drug in Phase III studies
for RRMS.

Of the 864 RRMS patients who participated in the original double-blind ALLEGRO
trial, 97% participated in the open-label extension and 87% completed one year
of the open-label phase. Overall, during the entire conduct of the study
(double blind and open label phase), early start patients were less likely to
experience disease progression than those with a delayed start of Laquinimod
(11.8% risk of confirmed disability progression vs 16.7%, HR = 0.62, p <

“The results of this longer-term study of laquinimod suggest a robust benefit
in terms of early treatment for RRMS and in potentially delaying disability,
which is a primary goal of RRMS treatment,” said Dr. Michael Hayden, President
of Global R&D and Chief Scientific Officer for Teva Pharmaceutical Industries,
Ltd. “The development of laquinimod’s clinical profile has been full of
exciting revelations about the compound’s unique mechanism of action, and we
were dually encouraged by the preclinical data which demonstrated a potential
direct effect on neuroregenerative processes.”

The study also supports a favorable safety and tolerability profile of
laquinimod in RRMS patients. No new safety concerns arose during the
open-label phase.

Additionally, a preclinical study in animal models demonstrated the ability of
laquinimod to increase the myelinated axons and mature oligodendrocytes in the
brain. This data suggests laquinimod has potential restorative and
anti-inflammatory properties.

Results of both studies will be shared with the scientific community following
a full analysis of the data.


Additional detail can be found on the AAN website:

[S41.004] Comparison of Early and Delayed Oral Laquinimod in Patients with
Relapsing-Remitting Multiple Sclerosis: Effects on Disability Progression at
36 Months in the ALLEGRO Trial
Giancarlo Comi, Milan, Italy, Douglas Jeffery, Advance, NC, Ludwig Kappos,
Basel, Switzerland, Xavier Montalban, Barcelona, Spain, Alexey Boyko, Moscow,
Russian Federation, Maria Rocca, Milan, Italy, Massimo Filippi, Milan, Italy

[P05.197] Therapeutic Laquinimod Treatment Restores Axon Myelination, Callosal
Conduction and Motor Deficit in a Chronic Mouse Model of Multiple Sclerosis
Spencer Moore, Los Angeles, CA, Gemmy Hannsun, Los Angeles, CA, Jane Yoon, Los
Angeles, CA, Rhusheet Patel, Los Angeles, Timothy Yoo, Los Angeles, CA, Anna
Khalaj, Los Angeles, CA, Seema Tiwari-Woodruff, Los Angeles, CA


Laquinimod is an oral, once-daily CNS-active immunomodulator with a novel
mechanism of action being developed for the treatment of MS. In animal models
laquinimod crosses the blood brain barrier to potentially have a direct effect
on resident CNS inflammation and neurodegeneration. The global Phase III
clinical development program evaluating oral laquinimod in MS includes two
pivotal studies, ALLEGRO and BRAVO. A third Phase III laquinimod trial,
CONCERTO, is evaluating two doses of the investigational product (0.6mg and
1.2mg) in approximately 1,800 patients for up to 24 months, after which
patients will continue to an active treatment period with laquinimod for
additional 24 months The primary outcome measure will be confirmed disability
progression as measured by the Expanded Disability Status Scale (EDSS).

In addition to the MS clinical studies, laquinimod is currently in clinical
development for Crohn's disease and Lupus.


MS is the leading cause of neurological disability in young adults. It is
estimated that more than 400,000 people in the United States are affected by
the disease and that two million people may be affected worldwide. Multiple
sclerosis is a degenerative disease of the central nervous system in which
inflammation and axonal damage and loss result in the development of
progressive disability.


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 specialty pharmaceuticals and active pharmaceutical ingredients.
Headquartered in Israel, Teva is a world leading generic drug maker, with a
global product portfolio of more than 1,300 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. Teva currently employs
approximately 46,000 people around the world and reached $20.3 billion in net
revenues in 2012.


Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company with
focus on autoimmune/inflammatory diseases and cancer. Projects in pivotal
phase are laquinimod, an orally administered small molecule with unique
immunomodulatory properties for the treatment of multiple sclerosis, TASQ for
prostate cancer and ANYARA primarily for the treatment of renal cell cancer.
In addition, laquinimod is in Phase II development for Crohn's and Lupus. The
company also has one additional project in clinical development, the orally
administered compound 57-57 for Systemic Sclerosis. Please visit
www.activebiotech.com for more information

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, 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 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.

Active Biotech's Safe Harbor Statement in Accordance with the Swedish
Securities Market Act:

This press release contains certain forward-looking statements. Such
forward-looking statements involve known and unknown risks, uncertainties and
other important factors that could cause the actual results, performance or
achievements of the company, or industry results, to differ materially from
any future results, performance or achievement implied by the forward-looking
statements. The company does not undertake any obligation to update or
publicly release any revisions to forward-looking statements to reflect
events, circumstances or changes in expectations after the date of this press

Active Biotech is obligated to publish the information contained in this press
release in accordance with the Swedish Securities Market Act.


Teva Pharmaceutical Industries Ltd.
Kevin C. Mannix
United States
Kristen Frank
United States
Tomer Amitai
972 (3) 926-7656
Hadar Vismunski-Weinberg
972 (3) 926-7687
Denise Bradley
United States
Active Biotech
Tomas Leanderson
Active Biotech AB
Hans Kolam
Active Biotech AB
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