Teva and Active Biotech Announce Discontinuation of Higher Doses of Laquinimod in Two Multiple Sclerosis Trials
January 04 2016 - 9:00AM
Business Wire
CONCERTO and ARPEGGIO Trials Continue Study
of Lower-dose Laquinimod
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and
Active Biotech (NASDAQ Stockholm:ACTI) today announced the
discontinuation of higher doses of laquinimod in two ongoing
studies in multiple sclerosis after the occurrence of
cardiovascular events, none of which was fatal, in eight
patients.
The change comes at the recommendation of the data monitoring
committee (DMC) overseeing two active clinical studies in MS. The
DMC identified an imbalance in the number of cardiovascular events
in the studies. Seven events were observed in patients receiving
laquinimod daily at 1.2mg for treatment of relapsing-remitting MS
(RRMS) in the CONCERTO trial. No events occurred in the 0.6mg or
placebo groups. CONCERTO has 2,199 patients with 3,070 years of
patient experience. One event was observed in the 1.5mg daily-dose
arm of the ARPEGGIO trial in primary-progressive MS (PPMS).
ARPEGGIO has enrolled 191 patients and has 35 years of patient
experience. Teva is notifying trial sites to discontinue the higher
doses immediately in both trials and will encourage participants to
continue follow ups.
Both trials, CONCERTO and ARPEGGIO, are continuing the
lower-dose arms (0.6mg daily), and participants in the trials will
be provided with an update to confirm re-consent for participation.
The DMC did not identify a cardiovascular signal with the lower
dose but recommended long-term monitoring. Teva has completed large
trials and is conducting long-term extension studies at the 0.6mg
dose currently without cardiovascular concerns.
Through a licensing agreement, Teva has global rights to develop
and commercialize laquinimod, a small-molecule entity discovered by
Active Biotech.
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),
primary-progressive MS (PPMS) and Huntington disease.
Details about clinical trials with laquinimod can be found at
clinicaltrials.gov. Trials mentioned in this release and the
clinicaltrials.gov reference number follow:
- CONCERTO (RRMS) -- NCT01707992
- ARPEGGIO (PPMS ) -- NCT02284568
- ALLEGRO extension (RRMS) –
NCT00988052
- BRAVO extension (RRMS) -
NCT01047319
- LAQ/5063-OL (RRMS) - NCT00745615
About TevaTeva 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 BiotechActive 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 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 specialty products, especially
Copaxone® (including competition from orally-administered
alternatives, as well as from generic equivalents such as the
recently launched Sandoz product) and our ability to continue to
migrate users to our 40 mg/mL version and maintain patients on that
version; our ability to identify and successfully bid for suitable
acquisition targets or licensing opportunities (such as our pending
acquisitions of Allergan’s generic business and Rimsa), or to
consummate and integrate acquisitions; 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;
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.
Active Biotech's Safe Harbor Statement in Accordance with the
Swedish Securities Market ActThis 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 18:00 CEST
on 01-04, 2016.
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version on businesswire.com: http://www.businesswire.com/news/home/20160104005710/en/
Teva Pharmaceutical Industries Ltd.IR:United StatesKevin C.
Mannix, (215) 591-8912orRan Mei, (215)
591-3033orIsraelTomer Amitai, 972 (3)
926-7656PR:IsraelIris Beck Codner, 972 (3) 926-7687orUnited
StatesDenise Bradley, (215) 591-8974orNancy Leone,
(215) 284-0213orActive BiotechTomas Leanderson,
+46-46-19-20-95orHans Kolam, +46-46-19-20-44
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