CONCERTO Study Enrolling Patients Globally to Evaluate Impact of
Laquinimod on Disability Progression
JERUSALEM & LUND, Sweden--(BUSINESS WIRE)--Mar. 6, 2013--
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Active Biotech
(NASDAQ OMX NORDIC: ACTI) announced today enrollment of the first
patient in the CONCERTO study - the third Phase III placebo-controlled
study designed to evaluate the efficacy, safety and tolerability of
once-daily oral laquinimod in patients with relapsing-remitting multiple
sclerosis (RRMS). The primary outcome measure of CONCERTO will be
confirmed disability progression as measured by the Expanded Disability
Status Scale (EDSS).
“Previous Phase III studies in more than 2,400 people with RRMS suggest
a unique profile of laquinimod, directly affecting the neurodegenerative
processes that lead to disability progression, the main concern in the
treatment of RRMS,” said CONCERTO principal investigator, Dr. Timothy
Vollmer, Professor of Neurology, University of Colorado Denver, Medical
Director of the Rocky Mountain Multiple Sclerosis Center, and
Co-Director of the RMMSC at Anschutz. “We are currently enrolling
patients in this third pivotal study to further examine the clinical
benefits of laquinimod on disability progression, the primary endpoint
of the CONCERTO trial, and brain atrophy, at both the previously studied
0.6 mg dose, and now a higher 1.2 mg dose.”
The multinational, randomized, double blind placebo-controlled study
will aim to enroll approximately 1,800 patients at more than 300 sites
globally (http://clinicaltrials.gov/show/NCT01707992).
Along with the primary endpoint of time to confirmed disability
progression, the study will also examine the impact of laquinimod on
endpoints such as percent change in brain volume and other clinical and
MRI markers of disease activity.
“For nearly 30 years, Teva has been focused on improving the lives of
people with multiple sclerosis by delivering innovative treatment
options that address this complex disease,” said Dr. Michael Hayden,
President of Global R&D and Chief Scientific Officer at Teva
Pharmaceutical Industries Ltd. “The CONCERTO study demonstrates our
commitment to collaborating with MS communities worldwide to further
develop laquinimod and address unmet patient needs.”
ABOUT LAQUINIMOD
Laquinimod is an oral, once-daily CNS-active immunomodulator with a
novel mechanism of action being developed for the treatment of MS. In
animal models 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 includes two pivotal studies, ALLEGRO and BRAVO.
In addition to the MS clinical studies, laquinimod is currently in
clinical development for Crohn's disease and Lupus.
ABOUT CONCERTO
CONCERTO is a multinational, multicenter, randomized, double-blind,
parallel-group, placebo-controlled study followed by an active treatment
phase, to evaluate the efficacy, safety and tolerability of two doses of
oral administration of laquinimod 0.6 mg/day or 1.2 mg/day in subjects
with RRMS. This third Phase III laquinimod study will evaluate
laquinimod in approximately 1,800 patients for up to 24 months, after
which patients will continue to an active treatment period with
laquinimod for an additional 24 months. The primary outcome measure will
be time to confirmed disability progression as measured by the Expanded
Disability Status Scale (EDSS). The study will also examine the impact
of laquinimod on endpoints such as percent change in brain volume, as
well as other clinical and MRI markers of disease activity.
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. (NYSE: 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
leading generic drug maker, with a global product portfolio of more than
1,000 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 $20.3 billion
in net revenues in 2012.
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
develop and commercialize additional pharmaceutical products,
competition for our innovative products, especially Copaxone® (including
competition from innovative orally-administered alternatives, as well as
from potential purported generic equivalents), competition for our
generic products (including from other pharmaceutical companies and as a
result of increased governmental pricing pressures), competition for our
specialty pharmaceutical businesses, our ability to achieve expected
results through our innovative R&D efforts, the effectiveness of our
patents and other protections for innovative products, decreasing
opportunities to obtain U.S. market exclusivity for significant new
generic products, our ability to identify, consummate and successfully
integrate acquisitions, the effects of increased leverage as a result of
the acquisition of Cephalon, the extent to which any manufacturing or
quality control problems damage our reputation for high quality
production and require costly remediation, our potential exposure to
product liability claims to the extent not covered by insurance,
increased government scrutiny in both the U.S. and Europe of our
agreements with brand companies, 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®,
our exposure to currency fluctuations and restrictions as well as credit
risks, the effects of reforms in healthcare regulation and
pharmaceutical pricing and reimbursement, any failures to comply with
complex Medicare and Medicaid reporting and payment obligations,
governmental investigations into sales and marketing practices
(particularly for our specialty pharmaceutical products), uncertainties
surrounding the legislative and regulatory pathway for the registration
and approval of biotechnology-based products, adverse effects of
political or economical instability, major hostilities or acts of
terrorism on our significant worldwide operations, interruptions in our
supply chain or problems with our information technology systems that
adversely affect our complex manufacturing processes, any failure to
retain key personnel or to attract additional executive and managerial
talent, the impact of continuing consolidation of our distributors and
customers, variations in patent laws that may adversely affect our
ability to manufacture our products in the most efficient manner,
potentially significant impairments of intangible assets and goodwill,
potential increases in tax liabilities, the termination or expiration of
governmental programs or tax benefits, environmental risks and other
factors that are discussed in our Annual Report on Form 20-F for the
year ended December 31, 2011 and in our 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.
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.
Teva Pharmaceutical Industries Ltd.
IR:
United States
Kevin
C Mannix, 215-591-8912
or
Kristen Frank,
215-591-8908
or
Israel
Tomer Amitai, 972 (3)
926-7656
or
Media:
Israel
Hadar Vismunski-Weinberg,
972 (3) 926-7687
or
United States
Denise Bradley,
215-591-8974
or
Active Biotech AB
Tomas Leanderson,
+46-46-19-20-95
or
Hans Kolam, +46-46-19-20-44