Phase III Study of Teva's Oral Laquinimod Published in the New England Journal of Medicine Demonstrates Clinical Benefits for Multiple Sclerosis Patients
(Thomson Reuters ONE) -
* Phase III ALLEGRO study results showed laquinimod reduced the annual rate of
relapses, slowed the progression of disability, and decreased brain tissue
loss
* Laquinimod was associated with favorable safety and tolerability profile
* European Union (EU) regulatory submission planned in H2 2012
Jerusalem, Israel and Lund, Sweden, March 15, 2012 -
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ
OMX NORDIC: ACTI) today announced the publication of results from the laquinimod
Phase III ALLEGRO study in the March 15 issue of The New England Journal of
Medicine (http://www.nejm.org/). Data from the two-year study showed that oral
once-daily laquinimod reduced inflammatory disease activity as measured by
clinical relapses and Magnetic Resonance Imaging (MRI), slowed disability
progression and decreased brain tissue loss, while maintaining a favorable
safety and tolerability profile in patients with relapsing-remitting multiple
sclerosis (RRMS).
"The positive findings from ALLEGRO provided evidence that laquinimod represents
a unique approach in the treatment of multiple sclerosis - one that offers
relapse management along with a significant reduction in the key outcome
measures correlated to irreversible nervous tissue damage," said Principal
Investigator, 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. "We are pleased to have
the results published in The New England Journal of Medicine."
The ALLEGRO results, along with results from the second global Phase III study
of laquinimod, BRAVO, will be included in the application for regulatory
approval planned for submission to the European Medicines Agency (EMA) in the
second half of this year.
"The publication of the ALLEGRO results in a prestigious peer-reviewed journal
is an important landmark as we continue to research and develop laquinimod,"
said Lesley Russell, Senior Vice President of R&D, Teva Global Branded Products.
"We look forward to continuing to work with regulatory authorities in both the
EU and the U.S. to bring this novel therapy to the MS community."
ABOUT ALLEGRO
The ALLEGRO 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. In the study, laquinimod showed a
statistically significant 23 percent reduction in annualized relapse rate
(P=0.002), 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). Additional analyses showed that the actual
proportion of patients with confirmed disability progression at the last
assessment was lower in the laquinimod group than in the placebo group (9.8
percent vs. 14.0 percent; P=0.04). 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<0.001).
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. 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 CNS-active immunomodulator with a novel
mechanism of action being developed for the treatment of MS. Laquinimod crosses
the blood brain barrier to potentially have a direct effect on resident CNS
inflammation and neurodegeneration. The global Phase III clinical development
program evaluating oral laquinimod in MS consists of two pivotal studies,
ALLEGRO and BRAVO.
In addition to the MS clinical studies, laquinimod is currently in Phase II
development for Crohn's disease and Lupus.
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 1,300 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 $18.3 billion in net revenues in 2011.
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 Systemic Sclerosis 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 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 version of Protonix(R), 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(R) (including potential generic and oral competition for Copaxone(R)),
the impact of continuing consolidation of our distributors and customers, our
ability to identify, consummate and successfully integrate acquisitions
(including the acquisition of Cephalon), 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 our Annual Report on Form 20-F and 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 required under the Securities Markets Act to make the
information in this press release public.
The information was submitted for publication at 1:00 p.m. CET on March
15, 2012.
# # #
Phase III Study of Teva's Oral Laquinimod Published :
http://hugin.info/1002/R/1594265/501883.pdf
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originality of the information contained therein.
Source: Active Biotech via Thomson Reuters ONE
[HUG#1594265]
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Datum: 15.03.2012 - 13:00 Uhr
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