Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) (TASE:TEVA)
and Active Biotech (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:TEVA) (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) (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.
IR Contacts: |
Kevin C. Mannix |
United States |
(215) 591-8912 |
|
Ran Meir |
United States |
(215) 591-3033 |
|
Tomer Amitai |
Israel |
972 (3) 926-7656 |
|
|
|
|
PR Contacts |
Iris Beck Codner |
Israel |
972 (3) 926-7687 |
|
Denise Bradley |
United States |
(215) 591-8974 |
|
Nancy Leone |
United States |
(215) 284-0213 |
|
|
|
|
Active Biotech |
Tomas Leanderson |
Active Biotech AB |
+46-46-19-20-95 |
|
Hans Kolam |
Active Biotech AB |
+46-46-19-20-44 |
# # #
Teva and Active Biotech Announce First Patient Enrolled in Phase
II http://hugin.info/1002/R/1913972/683780.pdf
HUG#1913972
Actividentity Corp (MM) (NASDAQ:ACTI)
Historical Stock Chart
From Apr 2024 to May 2024
Actividentity Corp (MM) (NASDAQ:ACTI)
Historical Stock Chart
From May 2023 to May 2024