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Active Biotech : EARLY VERSUS DELAYED TREATMENT WITH LAQUINIMOD DEMONSTRATED SIGNIFICANT REDUCTION IN RISK OF DISABILITY



 Active Biotech : 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

Jerusalem, Israel  and 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  < 
0.0038).  

"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.

ABOUT THE STUDIES
Additional    detail     can    be     found    on     the    AAN     website: 
http://www.abstracts2view.com/aan/

[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 
SclerosisSpencer 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

ABOUT LAQUINIMOD
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.

ABOUT MULTIPLE SCLEROSIS
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.

 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 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.

ABOUT ACTIVE BIOTECH
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 
release.
Active Biotech is obligated to publish the information contained in this press
release in accordance with the Swedish Securities Market Act. This information
was provided to the media for publication 1:00 p.m. CET on March 21, 2013.

 

IR         Kevin C.              United States              
Contacts:  Mannix                                             (215) 591-8912
           Kristen Frank         United States                (215) 591-8908
           Tomer                 Israel                       972 (3) 926-7656
           Amitai              
PR         Hadar                 Israel                       972 (3) 926-7687
Contacts   Vismunski-Weinberg
           Denise Bradley        United States                (215) 591-8974
Active     Tomas Leanderson      Active Biotech AB            +46-46-19-20-95
Biotech
           Hans Kolam            Active Biotech AB            +46-46-19-20-44

EARLY VERSUS DELAYED TREATMENT WITH LAQUINIMOD DEMONSTRATED

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Source: Active Biotech via Thomson Reuters ONE
HUG#1687014
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