Teva Announces Successful Results of Phase III Study with Oral Laquinimod For Multiple Sclerosis
- 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, 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™ for RA. 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 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.
Company Contacts:
Investor Relations:
Elana Holzman
Teva Pharmaceutical Industries Ltd.
972 (3) 926-7554
Kevin Mannix
Teva North America
(215) 591-8912
Media:
Yossi Koren
Teva Pharmaceutical Industries Ltd.
972 (3) 926-7590
Denise Bradley
Teva North America
(215) 591-8974
Posted: December 2010
