Market Snapshot
  • U.S.
  • Europe
  • Asia
Ticker Volume Price Price Delta
DJIA 16,424.85 162.29 1.00%
S&P 500 1,862.31 19.33 1.05%
NASDAQ 4,086.22 52.06 1.29%
Ticker Volume Price Price Delta
STOXX 50 3,139.26 47.74 1.54%
FTSE 100 6,584.17 42.56 0.65%
DAX 9,317.82 144.11 1.57%
Ticker Volume Price Price Delta
NIKKEI 14,417.68 420.87 3.01%
TOPIX 1,166.55 30.46 2.68%
HANG SENG 22,696.01 24.75 0.11%

First Patient Enrolled in Third Phase III Study of Oral Laquinimod for Relapsing-Remitting Multiple Sclerosis



  First Patient Enrolled in Third Phase III Study of Oral Laquinimod for
  Relapsing-Remitting Multiple Sclerosis

CONCERTO Study Enrolling Patients Globally to Evaluate Impact of Laquinimod on
                            Disability Progression

Business Wire

JERUSALEM & LUND, Sweden -- March 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.

Contact:

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
Sponsored Links
Advertisement
Advertisements
Sponsored Links
Advertisement