Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech AB (OMX
NORDIC: ACTI) announced that patients are being enrolled for the BRAVO Phase III
pivotal trial. BRAVO is a global, 24-month, double-blind study designed to
evaluate the efficacy, safety and tolerability of the oral compound laquinimod
versus placebo, and to provide risk-benefit data for laquinimod versus a
currently available injectable treatment,
Avonex®.
The BRAVO trial, which was initiated in April this year, aims to enroll
approximately 1,200 patients with relapsing-remitting multiple sclerosis (RRMS).
A second global Phase III trial of laquinimod including 1,000 patients, ALLEGRO,
is also ongoing and recruiting patients globally.
"All currently
approved multiple sclerosis (MS) treatments are administered via injection or
infusion. The ability to provide a safe and effective oral treatment option
would be a significant advancement for the treatment of MS," said Dr. Timothy
Vollmer, Medical Director, Rocky Mountain MS Center, Denver, Colorado, and
principal investigator of the BRAVO study. "Additionally, the mode of action for
laquinimod is unlike any other MS compound, existing or experimental. We are
hopeful that this research will expand our abilities to combat the disease
through novel targeting."
Data recently published in
The Lancet*
demonstrated that oral dose of laquinimod significantly reduced the median
magnetic resonance imaging (MRI) disease activity by 60 percent, compared to
placebo and was well tolerated in RRMS patients. The majority of patients from
the study are still receiving treatment with laquinimod in an open-label
extension trial.
The safety profiles of oral therapies are of increasing
interest to the MS community; We are hopeful that laquinimod will be both
efficacious and safe thus providing patients with an optimal risk-benefit
profile," said Dr. Per Soelberg Sorensen, Danish Multiple Sclerosis Research
Center, Department of Neurology, Copenhagen University Hospital, and principal
investigator of the BRAVO study.
About Multiple Sclerosis
Multiple Sclerosis (MS) is the leading cause of neurological
disability in young adults. It is estimated that over four hundred thousand
people in the United States 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 BRAVO BRAVO (benefit-risk assessment
of Avonex® and laquinimod) is a pivotal, multinational, multi-center,
randomized, double-blind, parallel-group, placebo-controlled study designed to
compare the safety and efficacy of laquinimod with placebo and to provide
risk-benefit data for laquinimod versus a currently available injectable
treatment, Avonex®. The enrollment goal is approximately 1,200 patients with
RRMS. The globally conducted study will include centers in the United States,
Europe, and Israel. To learn more about BRAVO visit
http://www.TevaClinicalTrials.com or call 1-800-840-5601.
About ALLEGRO ALLEGRO is a pivotal, global, 24/30-month,
double-blind, Phase III study designed to evaluate the efficacy, safety and
tolerability of laquinimod versus placebo in the treatment of
relapsing-remitting multiple sclerosis (RRMS). The Allegro trial aims to enroll
approximately 1,000 patients with RRMS. The globally conducted study will
include centers in the United States as well as centers throughout Canada,
Europe, and Israel. To learn more about Allegro, visit
http://www.TevaClinicalTrials.com or call +1 866 550 0614.
About Laquinimod Laquinimod is a novel once-daily, orally
administered immunomodulatory compound that is being developed as a
disease-modifying treatment for RRMS. Active Biotech developed laquinimod and
licensed it to Teva Pharmaceutical Industries, Ltd. in June 2004. A Phase IIb
study in 306 patients was recently published in The Lancet and demonstrated that
an oral 0.6 mg dose of laquinimod, administered daily, significantly reduced MRI
disease activity by a median of 60 percent versus placebo in RRMS patients.
Laquinimod also showed consistent and robust effect on all secondary MRI
endpoints. In addition, the study showed a favorable trend toward reducing
annual relapse rates and the number of relapse-free patients compared with
placebo. Treatment was well tolerated, with only some transient and
dose-dependent increases in liver enzymes reported. Over 460 MS patients have
received laquinimod in various Phase I-II clinical trials.
In addition
to the efficacy that laquinimod has shown in Phase II RRMS clinical trials,
laquinimod has demonstrated potent therapeutic efficacy in preclinical models of
other autoimmune diseases such as rheumatoid arthritis, insulin-dependent
diabetes mellitus, Guillain Barré Syndrome, lupus and Inflammatory Bowel
Disease. The broad profile of efficacy in animal models of inflammatory diseases
suggests that laquinimod affects a pivotal pathway of inflammation and
autoimmunity. Teva expects to initiate the clinical development of laquinimod
for Crohn's disease and Lupus Nephritis in the near future.
About
Teva Teva Pharmaceutical Industries Ltd., headquartered in Israel,
is among the top 20 pharmaceutical companies in the world and is the leading
generic pharmaceutical company. The company develops, manufactures and markets
generic and innovative pharmaceuticals and active pharmaceutical ingredients.
Over 80 percent of Teva's sales are in North America and Western Europe. Please
visit
http://www.tevapharm.com for more information on Teva
Phermaceutical Industries Ltd.
About Active Biotech
Active Biotech AB (OMX NORDIC: ACTI), headquartered in Sweden, is a
biotechnology company with R&D focus on autoimmune/inflammatory diseases and
cancer. Projects in pivotal phase are laquinimod, an orally administered small
molecule with unique immunomodulatory properties for the treatment of multiple
sclerosis, as well as ANYARA for use in cancer targeted therapy, primarily renal
cancer. Further key projects in clinical development comprise the three orally
administered compounds TASQ for prostate cancer, 57-57 for SLE and RhuDex® 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 1995This 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
Teva's 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: Teva's ability to accurately predict
future market conditions, potential liability for sales of generic products
prior to a final resolution of outstanding patent litigation, including that
relating to the generic versions of
Allegra®,
Neurontin®, Lotrel®,
Famvir®
and
Protonix®, Teva's ability to successfully develop and
commercialize additional pharmaceutical products, the introduction of competing
generic equivalents, the extent to which Teva may obtain U.S. market exclusivity
for certain of its new generic products and regulatory changes that may prevent
Teva from utilizing exclusivity periods, competition from brand-name companies
that are under increased pressure to counter generic products, or competitors
that seek to delay the introduction of generic products, the impact of
consolidation of our distributors and customers, the effects of competition on
our innovative products, especially
Copaxone®
sales, the impact of pharmaceutical industry regulation and pending legislation
that could affect the pharmaceutical industry, the difficulty of predicting U.S.
Food and Drug Administration, European Medicines Agency and other regulatory
authority approvals, the regulatory environment and changes in the health
policies and structures of various countries, our ability to achieve expected
results though our innovative R&D efforts, Teva's ability to successfully
identify, consummate and integrate acquisitions (including the pending
acquisition of Bentley Pharmaceuticals, Inc.), potential exposure to product
liability claims to the extent not covered by insurance, dependence on the
effectiveness of our patents and other protections for innovative products,
significant operations worldwide that may be adversely affected by terrorism,
political or economical instability or major hostilities, supply interruptions
or delays that could result from the complex manufacturing of our products and
our global supply chain, environmental risks, fluctuations in currency, exchange
and interest rates, and other factors that are discussed in Teva's Annual Report
on Form 20-F and its 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.
* *
Lancet 2008;371:2085-92
Teva Pharmaceutical
Industries Ltd.
