ORAL LAQUINIMOD FOR MULTIPLE SCLEROSIS TREATMENT SIGNIFICANTLY REDUCED DISEASE ACTIVITY AND DISABILITY PROGRESSION WHILE PROVIDING GOOD SAFETY AND TOLERABILITY
Apr 12, 2011 07:38 (CEST)
Teva Announces Updated Time For Webcast To Discuss Study Results On April
12th, 01:00 a.m. CET
- Phase III ALLEGRO study met primary endpoint and key secondary
endpoints:
o 23 percent reduction in annualized relapse rate
o 36 percent reduction in sustained disability progression
o 33 percent reduction in brain atrophy
o Safe and well-tolerated therapy without immunosuppressive effects
- Additional new pre-clinical data demonstrate potential neuroprotective
mechanism of action of laquinimod
Jerusalem, Israel and Lund, Sweden, April 12, 2011 - Teva Pharmaceutical
Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI)
announced today results from the two-year Phase III ALLEGRO study of laquinimod,
an oral, once-daily, investigational immunomodulator for the treatment of
relapsing forms of multiple sclerosis (MS). These data will be presented as
late-breaking research at the Annual Meeting of the American Academy of
Neurology (AAN).
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).
"The ALLEGRO study results are exciting, as they suggest that oral laquinimod is
a novel therapeutic option that safely slows MS disease activity and
progression," said Principal Investigator, Professor Giancarlo Comi, Director of
the Department of Neurology and Institute of Experimental Neurology at the
University Vite Salute, San Raffaele, Italy. "Additional pre-clinical data
presented at this meeting suggest that oral laquinimod exerts a novel and
protective mechanism of action within the central nervous system to
significantly reduce the main neurological damage of the disease."
Laquinimod was safe and well-tolerated without immunosuppressive effects. 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. No deaths were reported
in laquinimod-treated patients.
The positive ALLEGRO results are supported by new pre-clinical data, also
presented at the AAN meeting, that further establish the mechanism of action
(MOA) of laquinimod, which led to a reduction in axonal damage, the main
determinant of permanent clinical disability in MS. Data from the cuprizone
model, designed to investigate the effect on neurodegeneration, independent of
inflammation, demonstrated that laquinimod reduced demyelination and axonal
damage while preserving more myelin-producing cells. This unique effect suggests
a direct decrease in nerve damage in the central nervous system (CNS).
Additionally, laquinimod was shown to modulate the brain-derived neurotrophic
factor (BDNF) pathway, a key factor in maintaining axonal integrity.
"We are very enthusiastic about the results of the ALLEGRO study, which
demonstrated that laquinimod significantly slows the progression of disability,
the primary goal of MS treatment. Given the efficacy, safety and tolerability
data to date, laquinimod may present a very promising treatment option to the MS
community," said Professor Yitzhak Peterburg, Teva's Group Vice President,
Global Branded Products.
The second laquinimod Phase III study, BRAVO, is currently ongoing with results
anticipated in the third quarter of 2011. Regulatory submissions are planned in
the U.S. and the EU following the availability of the BRAVO results.
CONFERENCE CALL/WEBCAST
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) will host an audio webcast on
April 11(th), 2011 at 7:00 p.m. EDT to present the results from the Phase III
ALLEGRO study of laquinimod. Those interested in listening to the webcast should
log on to http://www.tevapharm.com/financial/ and register for the event
(approximately 10 minutes before). The dial-in for this call is 1-800-215-2410
or 617-597-5410 internationally. The conference ID or passcode is 14479443. An
archive of the webcast will be available on Teva's website.
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.
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 LAQUINIMOD
Laquinimod is an oral, once-daily, immunomodulator with a novel mechanism of
action being developed for the treatment of MS. The global Phase III clinical
development program evaluating oral laquinimod in MS consists of two pivotal
studies, ALLEGRO and BRAVO. BRAVO, is 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 perform a comparative risk-benefit assessment
between laquinimod and interferon beta-1a. Enrollment of 1,332 patients at 154
sites in the U.S, Europe, Israel and South Africa was completed in June 2009.
BRAVO study results are anticipated in the third quarter of 2011.
In addition to the ongoing MS clinical studies, laquinimod is currently in Phase
II development for Crohn's disease and Lupus, and is being studied in other
autoimmune diseases.
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. (NASDAQ: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 largest generic drug
maker, with a global product portfolio of more than 1,450 molecules and a direct
presence in 60 countries. Teva's branded businesses focus on neurological,
respiratory and women's health therapeutic areas as well as biologics. Teva's
leading innovative product, Copaxone(®), is the number one prescribed treatment
for multiple sclerosis. Teva employs approximately 40,000 people around the
world and reached $16.1 billion in net sales in 2010.
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 www.activebiotech.comfor 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 successfully develop and commercialize additional
pharmaceutical products, the introduction of competing generic equivalents, the
extent to which we may obtain U.S. market exclusivity for certain of our new
generic products and regulatory changes that may prevent us from utilizing
exclusivity periods, potential liability for sales of generic products prior to
a final resolution of outstanding patent litigation, including that relating to
the generic versions of Neurontin®, Lotrel®, Protonix® and Gemzar®, the extent
to which any manufacturing or quality control problems damage our reputation for
high quality production, the effects of competition on sales of our innovative
products, especially Copaxone® (including potential generic and oral competition
for Copaxone®), the impact of continuing consolidation of our distributors and
customers, our ability to identify, consummate and successfully integrate
acquisitions (including the acquisition of ratiopharm), interruptions in our
supply chain or problems with our information technology systems that adversely
affect our complex manufacturing processes, intense competition in our specialty
pharmaceutical businesses, any failures to comply with the complex Medicare and
Medicaid reporting and payment obligations, our exposure to currency
fluctuations and restrictions as well as credit risks, the effects of reforms in
healthcare regulation, adverse effects of political or economical instability,
major hostilities or acts of terrorism on our significant worldwide operations,
increased government scrutiny in both the U.S. and Europe of our agreements with
brand companies, dependence on the effectiveness of our patents and other
protections for innovative products, our ability to achieve expected results
through our innovative R&D efforts, the difficulty of predicting U.S. Food and
Drug Administration, European Medicines Agency and other regulatory authority
approvals, uncertainties surrounding the legislative and regulatory pathway for
the registration and approval of biotechnology-based products, potentially
significant impairments of intangible assets and goodwill, potential increases
in tax liabilities resulting from challenges to our intercompany arrangements,
our potential exposure to product liability claims to the extent not covered by
insurance, the termination or expiration of governmental programs or tax
benefits, current economic conditions, any failure to retain key personnel or to
attract additional executive and managerial talent, environmental risks and
other factors that are discussed in this report and in our other filings with
the U.S. Securities and Exchange Commission.
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 on April 12, 2011, at 7:30 a.m.
CET.
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ORAL LAQUINIMOD FOR MULTIPLE SCLEROSIS TREATMENT :
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