Phase II ARPEGGIO
study design to be presented at the 67th American
Academy of Neurology (AAN) Annual Meeting,
April 18-25, 2015
Jerusalem, Israel
& Lund, Sweden - April 23, 2015 - Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA) and Active Biotech (NASDAQ
STOCKHOLM: ACTI) today announced the first patient has been
enrolled in the study A Randomized Placebo-controlled
Trial Evaluating Laquinimod in PPMS, Gauging Gradations In MRI and Clinical Outcomes
(ARPEGGIO), a Phase II study to evaluate laquinimod, an
investigational, oral, immune modulator, for the treatment of
primary progressive multiple sclerosis (PPMS). Currently there are
no approved treatments for PPMS, representing a condition with a
high unmet need.
PPMS affects approximately 15
percent of all MS patients and is characterized by the worsening of
neurologic function without distinct relapses (also called attacks
or exacerbations). Unlike patients with relapsing-remitting MS
(RRMS), those with PPMS tend to have more lesions in the spinal
cord than in the brain and these brain lesions usually contain
fewer inflammatory cells. In addition, all studies evaluating RRMS
treatments in patients with PPMS have failed to prove effective for
this condition.
"Laquinimod may represent an
opportunity to help meet the challenge of PPMS," said Michael
Hayden, M.D., Ph.D., President of Global R&D and Chief
Scientific Officer at Teva. "The mechanisms of action and data from
previous studies in RRMS suggest the effect of laquinimod is
focused on the neurodegenerative aspects of the disease, which are
pervasive in PPMS. We are hopeful that the ARPEGGIO study will
demonstrate the ability of laquinimod to slow disability
progression in PPMS and fulfill an unmet need for patients with
this lifelong and debilitating disease."
ARPEGGIO is a multinational,
multicenter, randomized, double-blind, parallel-group,
placebo-controlled study of once-daily, oral laquinimod (0.6mg or
1.5mg/day) in patients with PPMS. The study's primary endpoint is
percent brain volume change (PBVC) through MRI analysis. The trial
will enroll approximately 375 patients in the U.S., Canada, and
Europe.
Additional details on the study
design will be presented at the AAN Annual Meeting in Washington,
D.C. on Thursday, April 23, 2015 during Poster Session 7. For
further details on the Phase II ARPEGGIO study, please visit
clinicaltrials.gov/show/NCT02284568.
About
Laquinimod
Laquinimod is a once-daily oral, investigational, CNS-active
immunomodulator with a novel mechanism of action being developed
for the treatment of relapsing-remitting MS (RRMS), progressive MS
and Huntington's disease. The global, Phase III, clinical
development program evaluating laquinimod in MS includes two
completed pivotal studies, ALLEGRO and BRAVO (both 0.6mg/day). A
third Phase III trial, CONCERTO, is currently ongoing and
evaluating two doses of laquinimod (0.6mg and 1.2mg/day) in
approximately 2,100 patients for up to 24 months. The primary
outcome measure is time to three-month confirmed-disability
progression as measured by the Expanded Disability Status Scale
(EDSS).
In the ALLEGRO and BRAVO trials,
adverse reactions observed included headache, abdominal pain, back
and neck pain, appendicitis, and mild, asymptomatic laboratory
abnormalities, including liver enzyme elevations, hematological
changes and elevation of CRP or fibrinogen levels.
About
Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions to millions of patients every
day. Headquartered in Israel, Teva is the world's largest generic
medicines producer, leveraging its portfolio of more than 1,000
molecules to produce a wide range of generic products in nearly
every therapeutic area. In specialty medicines, Teva has a
world-leading position in innovative treatments for disorders of
the central nervous system, including pain, as well as a strong
portfolio of respiratory products. Teva integrates its generics and
specialty capabilities in its global research and development
division to create new ways of addressing unmet patient needs by
combining drug development capabilities with devices, services and
technologies. Teva's net revenues in 2014 amounted to $20.3
billion. For more information, visit www.tevapharm.com.
About Active
Biotech
Active Biotech AB (publ) (Nasdaq Stockholm: ACTI) is a
biotechnology company with focus on neurodegenerative/inflammatory
diseases and cancer. Laquinimod, an orally administered small
molecule with unique immunomodulatory properties, is in pivotal
phase III development for the treatment of relapsing remitting
multiple sclerosis. Also, laquinimod is in phase II development for
the treatment of primary progressive multiple sclerosis and
Huntington's disease.
The project portfolio includes a preclinical project, ISI, with the
objective to produce new, patentable chemical compounds for
treatment of diseases within the company's focus areas. Please
visit 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 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 orally-administered alternatives, as well as from
potential purported generic equivalents) and
our ability to migrate users to our 40 mg/mL version; the
possibility of material fines, penalties and other sanctions and
other adverse consequences arising out of our ongoing FCPA
investigations and related matters; our ability to achieve expected
results from the research and development efforts invested in our
pipeline of specialty and other products; our ability to reduce
operating expenses to the extent and during the timeframe intended
by our cost reduction program; our ability to identify and
successfully bid for suitable acquisition targets or licensing
opportunities, or to consummate and integrate acquisitions; the
extent to which any manufacturing or quality control problems
damage our reputation for quality production and require costly
remediation; increased government scrutiny in both the U.S. and
Europe of our patent settlement agreements; our exposure to
currency fluctuations and restrictions as well as credit risks; the
effectiveness of our patents, confidentiality agreements and other
measures to protect the intellectual property rights of our
specialty medicines; the effects of reforms in healthcare
regulation and pharmaceutical pricing, reimbursement and coverage;
governmental investigations into sales and marketing practices,
particularly for our specialty pharmaceutical products; adverse
effects of political or economic instability, major hostilities or
acts of terrorism on our significant worldwide operations;
interruptions in our supply chain or problems with internal or
third-party information technology systems that adversely affect
our complex manufacturing processes; significant disruptions of our
information technology systems or breaches of our data security;
competition for our generic products, both from other
pharmaceutical companies and as a result of increased governmental
pricing pressures; competition for our specialty pharmaceutical
businesses from companies with greater resources and capabilities;
the impact of continuing consolidation of our distributors and
customers; decreased opportunities to obtain U.S. market
exclusivity for significant new generic products; potential
liability in the U.S., Europe and other markets for sales of
generic products prior to a final resolution of outstanding patent
litigation; our potential exposure to product liability claims that
are not covered by insurance; any failure to recruit or retain key
personnel, or to attract additional executive and managerial
talent; any failures to comply with complex Medicare and Medicaid
reporting and payment obligations; significant impairment charges
relating to intangible assets, goodwill and property, plant and
equipment; the effects of increased leverage and our resulting
reliance on access to the capital markets; potentially significant
increases in tax liabilities; the effect on our overall effective
tax rate of the termination or expiration of governmental programs
or tax benefits, or of a change in our business; variations in
patent laws that may adversely affect our ability to manufacture
our products in the most efficient manner; environmental risks; and
other factors that are discussed in our Annual Report on Form 20-F
for the year ended December 31, 2014 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 we
assume 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. This
information was provided to the media for publication at 8:00 pm
CET on April 23, 2015.
# # #
Teva and Active Biotech Announce
First Patient Enrolled in Phase II
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Active Biotech via Globenewswire
HUG#1913972
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