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 reassessment 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20150625005155/en/
InvestorsTeva Pharmaceutical Industries Ltd.United StatesKevin
C. Mannix, 215-591-8912Ran Meir, 215-591-3033orIsraelTomer Amitai,
972 (3) 926-7656orMediaTeva United StatesDenise Bradley,
215-591-8974Nancy Leone, 215-591-8974orTeva IsraelIris Beck Codner,
972 (3) 926-7687orActive Biotech ABTomas Leanderson,
+46-46-19-20-95Hans Kolam, +46-46-19-20-44
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