Jerusalem &
Lund, Sweden - June 25, 2015 - Teva Pharmaceutical Industries
Ltd. (NYSE and TASE: TEVA) and Active Biotech (NASDAQ Stockholm:
ACTI) today announced that the patient enrollment for the pivotal
Phase III CONCERTO trial has been finalized, as well as a planned
sample size re-assessment analysis of the study. CONCERTO, the
third Phase III trial of laquinimod in patients with
relapsing-remitting multiple sclerosis (RRMS), is designed to
evaluate the safety and efficacy of laquinimod (0.6mg or 1.2mg/day)
with a primary endpoint of time to Confirmed Disability Progression
(CDP), as measured by the Expanded Disability Status Scale
(EDSS).
The sample size re-assessment was included as part
of the protocol to confirm that the original assumptions are in
line with the study and that the sample size is adequate. Based on
recent agreement with FDA, under a Special Protocol Assessment
(SPA) agreement, study completion will occur when either 260 events
are reached or all patients complete 24 months of study treatment
(whichever occurs first). CONCERTO study results are expected to be
available toward mid-2017. Regulatory submission will follow study
completion.
"We are committed to realizing the full potential
of laquinimod. The molecule has a unique mechanism for future
treatment of MS and other neurodegenerative diseases by working
directly in the Central Nervous System, showing promise to prevent
brain atrophy and slow disability progression in these patients,"
said Michael Hayden, M.D., Ph.D., President of Global R&D and
Chief Scientific Officer at Teva.
Laquinimod is also being tested in Phase II trials
for the treatment of subjects with primary progressive MS and
Huntington disease; two diseases for which no approved disease
modifying therapies are available. For further details on the Phase
III CONCERTO study, please visit
https://clinicaltrials.gov/ct2/show/NCT01707992.
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 2,199
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. Furthermore,
commercial activities are ongoing for the projects ISI, ANYARA and
paquinimod. 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 and/or
the Financial Instruments Trading Act. This information was provided to the
media for publication at 2:00 p.m. CEST on 06-25, 2015.
# # #
Teva and Active Biotech Announce
Completion of Patient Enrollment
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#1931462
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