-
Phase III ALLEGRO study results showed laquinimod reduced the
annual rate of relapses, slowed the progression of disability, and
decreased brain tissue loss
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Laquinimod was associated with favorable safety and tolerability
profile
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European Union (EU) regulatory submission planned in H2 2012
JERUSALEM & LUND, Sweden--(BUSINESS WIRE)--Mar. 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 SLE & Systemic Sclerosis and RhuDex(TM) 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 obligated to publish the information contained in
this press release in accordance with the Swedish Securities Market Act.
Source: Teva Pharmaceutical Industries Ltd.
IR Contacts:
United States
Kevin C. Mannix, 215-591-8912
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
PR Contacts:
United States
Denise
Bradley, 215-591-8974
or
Israel
Shir Altay-Hagoel,
972 (3) 926-7590
or
Active Biotech:
Active Biotech AB
Tomas
Leanderson, +46-46-19-20-95
or
Active Biotech AB
Hans
Kolam, +46-46-19-20-44