New Data Presented at 29th ECTRIMS Congress Reinforce the Clinical Profile of Investigational Laquinimod on Disease Progression and Inflammation in Relapsing-Remitting Multiple Sclerosis

October 4, 2013 15:36 (CEST)

Pooled Data Analysis of Phase III ALLEGRO and BRAVO Studies Add to our Understanding of Investigational Laquinimod for Relapsing-Remitting Multiple Sclerosis (RRMS)

JERUSALEM and LUND, Sweden, Oct. 4, 2013 (GLOBE NEWSWIRE) --

     
Teva Pharmaceutical Industries Ltd.
(NYSE: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) announced today the
presentation of post-hoc analyses of the Phase III ALLEGRO and BRAVO studies
supporting that once-daily, oral laquinimod may have an effect on both
inflammation and the broader underlying mechanisms associated with disease
progression in relapsing-remitting multiple sclerosis. Various new laquinimod
data will be featured in 16 scientific posters and presentations at the 29th
Congress of the European Committee for Treatment and Research in Multiple
Sclerosis (ECTRIMS) in Copenhagen, Denmark, October 2-5, 2013.

"Several post-hoc analyses of the pooled data from the ALLEGRO and BRAVO Phase
III studies demonstrates that the trend of efficacy results was maintained in
the analysis of data pooled from the two studies, and is consistent with the
proposed mechanism of action for laquinimod, " said Dr. Michael Hayden,
President of Global R&D and Chief Scientific Officer for Teva Pharmaceutical
Industries Ltd. "Teva remains committed to the laquinimod clinical development
program in MS and in other diseases characterized by a neurodegenerative
pathology, and to addressing the needs of these patients worldwide."

Results from a post-hoc subgroup analysis of pooled data from the Phase III
double-blind ALLEGRO and BRAVO studies showed there were some patients who
experienced disease progression without experiencing a relapse during the
studies. Regardless of treatment arm and despite relapse status, 12 percent of
patients studied experienced disability progression after two years; of those
patients who progressed, approximately one-third did not experience a relapse.
Results specific to treatment with laquinimod showed that both relapsing and
relapse-free patients treated with laquinimod experienced less disease
progression than those treated with placebo. Overall, laquinimod reduced three-
month confirmed disability progression by 26.7 percent in relapsing patients
(P=0.058) and 38.9 percent in relapse-free patients (P=0.036) compared to
placebo.

"We have made significant progress in understanding the pathology of multiple
sclerosis however it remains a complex and often unpredictable disease," said
Professor Giancarlo Comi, Director of the Department of Neurology and Institute
of Experimental Neurology at the San Raffaele Scientific Institute, Vita-Salute
San Raffaele University, Italy. "When patients show disease progression but do
not experience a relapse, it suggests that disability progression and relapses
are not solely mediated through a common pathway. The data presented at ECTRIMS
support the notion that laquinimod may have an effect not only on acute
inflammatory attacks but also on broader underlying mechanisms."

Results of this and additional post-hoc analyses of the pooled data from the
ALLEGRO and BRAVO Phase III studies reinforcing the novel clinical profile of
laquinimod on disease progression and inflammation will be presented at the
ECTRIMS Congress as follows:
·       Disease progression in relapse-free patients treated with laquinimod,
Friday, October 4, 15:30 - 17:00 CET (P1036, Poster Session: Long-term treatment
monitoring)
·       Bayesian analysis of laquinimod's effect on relapses and disability,
Thursday, October 3, 14:30 - 17:00 CET (P606, Poster Session: Tools for
detecting therapeutic response)
·       Evaluating the relationship between laquinimod's effects on relapse and
disability progression, Friday, October 4, 15:30 - 17:00 CET (P1080, Poster
Session: Tools for detecting therapeutic response)
·       The risk of disability progression is associated with multiple sclerosis
functional composite (MSFC) scores in the laquinimod phase 3 trials, Friday,
October 4, 15:30 - 17:00 CET (P1057, Poster Session: Long-term treatment
monitoring)

Both the ALLEGRO and BRAVO studies found that laquinimod demonstrated a
tolerable clinical profile compared to placebo. The overall frequencies of
adverse events, including incidence of infections, were comparable to those
observed in the placebo group. The most commonly reported adverse events were
headaches, nasopharyngitis and back pain. The incidence of liver enzyme
elevation was higher in laquinimod treated patients; however, these elevations
were transient, asymptomatic and reversible.

ABOUT THE ALLEGRO STUDY
ALLEGRO was a two-year, multi-national, multi-center randomized, double blind,
placebo-controlled study designed to evaluate the efficacy, safety and
tolerability of laquinimod in MS patients. The study was conducted at 139 sites
in 24 countries and enrolled 1,106 MS patients. Patients were randomized to
receive a once-daily oral dose of 0.6 mg laquinimod or matching placebo. The
primary outcome measure was the number of confirmed relapses; secondary measures
included confirmed disability progression and changes in MRI active lesions.

In the ALLEGRO study, laquinimod showed a statistically significant 23 percent
reduction in annualized relapse rate (p=0.0024), the primary endpoint, along
with a significant 36 percent reduction in the risk of confirmed disability
progression, as measured by Expanded Disability Status Scale (EDSS) (p=0.0122).
Treatment with laquinimod was also associated with a significant reduction in
brain tissue loss, as measured by a 33 percent reduction in progression of brain
atrophy (p<0.0001).

Eighty percent of laquinimod and 77 percent of placebo patients completed the
two-year study. Patients who completed the ALLEGRO study were offered to join an
open-label extension phase, in which they are being treated with laquinimod 0.6
mg daily.

ABOUT THE BRAVO STUDY
BRAVO was a two-year, multi-national, multi-center, randomized, double-blind,
parallel-group, placebo-controlled study designed to compare the safety,
efficacy and tolerability of a once-daily oral dose of 0.6 mg laquinimod over
placebo and to provide a descriptive comparison of the risk-benefit profiles of
laquinimod and interferon beta-1a. The primary outcome measure was to assess the
efficacy of 0.6 mg daily dose of laquinimod as measured by the relapse rate.
Secondary outcome measures included impact on the accumulation of disability and
brain atrophy. The BRAVO study completed enrollment in June 2009, recruiting
more 1,331 patients at 153 sites worldwide, including in the U.S., Europe,
Russia, Israel and South Africa.

Results showed that the BRAVO study did not achieve its primary endpoint of
reducing the annualized relapse rate (p=0.075).

ABOUT LAQUINIMOD
Laquinimod is an oral, investigational, CNS-active immunomodulator with a novel
mechanism of action being developed for the treatment of relapsing-remitting MS
(RRMS). 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.
The primary outcome measure will be time to confirmed disability progression as
measured by the EDSS.

In addition to the MS clinical studies, laquinimod is currently in Phase II of
development for Crohn's disease and lupus nephritis.  Further studies are
planned to determine the effectiveness of laquinimod in treating patients with
Huntington's disease and Alzheimer's disease.

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 $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 or entering
pivotal phase are laquinimod, an orally administered small molecule with unique
immunomodulatory properties for the treatment of multiple sclerosis, TASQ for
prostate cancer as well as ANYARA for use in cancer targeted therapy, primarily
of renal cell cancer. In addition, laquinimod is in Phase II development for
Crohn's and Lupus. Further projects in clinical development comprise the two
orally administered compounds, 57-57 for SLE & Systemic Sclerosis and RhuDex(TM)
for RA. Please visit http://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,  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 3:30 pm CET on October 4, 2013.


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 IR         Kevin C.              United
 Contacts   Mannix                States                       (215) 591-8912

            Kristen Frank         United States                (215) 591-8908
            Tomer                 Israel                       (972 (3)
            Amitai                                             926-7656



 PR         Iris Beck Codner      Israel                       972 (3) 926-7687
 Contacts

            Denise Bradley        United States                (215) 591-8974
            Nancy Leone           United States                (215) 284-0213


 Active     Tomas Leanderson      Active Biotech AB            +46-46-19-20-95
 Biotech

            Hans Kolam            Active Biotech AB            +46-46-19-20-44






New Data Presented at 29th ECTRIMS Congress: http://hugin.info/1002/R/1733650/580518.pdf

[HUG#1733650]