TEVA ANNOUNCES SUCCESSFUL RESULTS OF PHASE III STUDY WITH ORAL LAQUINIMOD FOR MULTIPLE SCLEROSIS
Dec 9, 2010 07:30 (CET)
* Laquinimod study met primary endpoint of reducing annualized relapse rate
* Treatment with laquinimod significantly slowed progression of disability
* Laquinimod data showed a favorable safety and tolerability profile
Jerusalem, Israel and Lund, Sweden, December 9, 2010 - Teva Pharmaceutical
Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI)
announced today initial results from the two-year Phase III ALLEGRO study, which
demonstrated that relapsing-remitting multiple sclerosis (MS) patients treated
with 0.6 mg daily oral laquinimod experienced a statistically significant
reduction in annualized relapse rate compared to placebo. Additional clinical
endpoints, including significant reduction in disability progression, as
measured by Expanded Disability Severity Scale (EDSS), were also achieved.
Laquinimod was safe and well-tolerated. The overall frequencies of adverse
events were comparable to those observed in the placebo group. No deaths were
reported in laquinimod-treated patients. Overall incidence of infections was
similar between the two arms of the trial.
"This pivotal study met its primary endpoint while maintaining a very good
safety profile," says Principal Investigator, Professor Giancarlo Comi, Director
of the Department of Neurology and Institute of Experimental Neurology at the
University Vite Salute, San Raffaele, Italy. "Laquinimod demonstrated a
significant reduction in the progression of disability which may be explained by
its unique mechanism of action that includes neuroprotective properties.
Laquinimod may therefore be a promising therapeutic option for the MS
community."
"We are very pleased to have achieved this major milestone in the development of
oral laquinimod, a novel therapy that can potentially improve the lives of many
MS patients in a safe way," said Shlomo Yanai, Teva's President and Chief
Executive Officer.
Additional analyses of the ALLEGRO study data are ongoing, and detailed results
will be submitted for presentation at a leading scientific conference during the
first half of 2011.
Laquinimod received Fast Track designation from the U.S. Food and Drug
Administration (FDA) in February 2009. The second phase III study, BRAVO is
still ongoing with results anticipated in the third quarter of 2011. Regulatory
submissions in the U.S. and the EU will then follow.
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.
Following the successful study results, Teva filed a patent application covering
the use of laquinimod in slowing the progression of disability in MS patients.
ABOUT LAQUINIMOD
Laquinimod is a novel once-daily, oral immunomodulatory compound being developed
as a disease-modifying treatment for MS. The global Phase III clinical
development program evaluating oral laquinimod in MS consists of two pivotal
studies, ALLEGRO and BRAVO:
* The first clinical 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,. Patients who
completed the ALLEGRO study are offered to join an open-label extension
phase, in which they will be treated with laquinimod 0.6mg daily until the
drug is commercially available.
* The second clinical study, 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 expected 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
Multiple sclerosis (MS) is the leading cause of neurological disability in young
adults. It is estimated that more than 400,000 people in the U.S. are affected
by the disease and that two million people may be affected worldwide. MS is a
progressive, demyelinating disease of the central nervous system affecting the
brain, spinal cord and optic nerves. Demyelination is the destructive breakdown
of the fatty tissue that protects nerve endings.
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 1,250 molecules and a direct
presence in approximately 60 countries. Teva's branded businesses focus on
neurology, oncology, respiratory and women's health therapeutic areas as well as
biosimilars. Teva's leading innovative product, Copaxone®, is the number one
prescribed treatment for multiple sclerosis. Teva employs more than 40,000
people around the world and reached $13.9 billion in net sales in 2009.
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 successful completion of the laquinimod trials,
receipt of regulatory approvals and commercialization of laquinimod, 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 Yaz®, 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 ("SEC").
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. The information
was submitted for publication at 7:30 am CET on December 9, 2010.
TEVA ANNOUNCES SUCCESSFUL RESULTS OF PHASE III STUDY WITH ORAL LAQUINIMOD FOR MULTIPLE SCLEROSIS:
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