New Data Presented at 29th ECTRIMS Congress Reinforce the Clinical Profile of Investigational Laquinimod on Disease Progression and Inflammation in Relapsing-Remitting Multiple Sclerosis
(Thomson Reuters ONE) -
Pooled Data Analysis of Phase III ALLEGRO and BRAVO Studies Add to our
Understanding of Investigational Laquinimod for Relapsing-Remitting Multiple
Sclerosis (RRMS)
Jerusalem & Lund, Sweden, October 4, 2013 - 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
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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,
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leverage as a result of recent acquisitions, the extent to which any
manufacturing or quality control problems damage our reputation for high quality
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liability claims to the extent not covered by insurance, increased government
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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
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IR Kevin C. United
Contacts Mannix States (215) 591-8912
Kristen Frank United States (215) 591-8908
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Amitai 926-7656
PR Iris Beck Codner Israel 972 (3) 926-7687
Contacts
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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
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Source: Active Biotech via Thomson Reuters ONE
[HUG#1733650]
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