Teva and Active Biotech Announce Discontinuation of Higher Doses of Laquinimod in Two Multiple Sclerosis Trials
January 04 2016 - 9:00AM
CONCERTO and
ARPEGGIO Trials Continue Study of Lower-dose Laquinimod
Jerusalem &
Lund, Sweden - January 4, 2016 - 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
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 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 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 15:00 CET on Jan 4,
2016.
IR Contacts: |
Kevin C. Mannix |
United States |
(215) 591-8912 |
|
Ran
Meir
Tomer Amitai |
United States
Israel |
(215) 591-3033
972 (3) 926-7656 |
PR Contacts |
Iris Beck
Codner |
Israel |
972 (3) 926-7687 |
|
Denise
Bradley
Nancy Leone |
United States
United States |
(215) 591-8974
(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
Discontinuation of Higher Doses of La
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
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