Teva and Active Biotech Announce CONCERTO trial of Laquinimod in RRMS Did Not Meet Primary Endpoint
05 Mai 2017 - 8:00PM
Business Wire
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and
Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced results
from the CONCERTO trial in patients with relapsing-remitting
multiple sclerosis (RRMS). The primary endpoint in CONCERTO -- the
evaluation of laquinimod (0.6 mg/daily capsules) versus placebo to
evaluate the time to Confirmed Disability Progression (CDP) after
at least 3 months – was not met. (Hazard Ratio of 0.937, p =
0.7057).
Other data details announced by the Company show that on the
secondary endpoint which measured change in brain volume-- an
indicator of disability progression over time-- compared to
baseline was positive (40% improvement over placebo at month 15, p
< 0.0001). Other encouraging results were seen on the secondary
endpoint of time to first relapse (risk reduced by 28%; p = 0.0001)
and the exploratory endpoint of annualized relapse rate (risk
reduced by 25%; p=0.0001). As with the primary endpoint, secondary
endpoints measuring time to CDP at 6 and 9 months did not reach
significance. On the exploratory endpoint of reduction of the
number of gadolinium-enhancing T1 lesions at month 15, laquinimod
demonstrated a 30% reduction (p=0.004).
“We have learned a great deal from the CONCERTO trial and we
will continue our analysis of the data,” said Michael Hayden, M.D.,
Ph.D., President of Global R&D and Chief Scientific Officer at
Teva. “Although we are disappointed by not meeting the primary
endpoint, we did see positive results on a number of secondary and
exploratory endpoints which fuels our belief in the potential of
laquinimod as a possible treatment for neurodegenerative diseases.
While we have no current plans to further pursue laquinimod in
RRMS, we are continuing to study it in two other trials.”
The clinical safety profile of laquinimod 0.6 mg daily, which
had been previously studied with over 12,000 patient-years of
exposure, was confirmed in CONCERTO. Adverse events reported in 5%
or more of CONCERTO patients taking 0.6 mg daily of laquinimod were
headache (17%), nasopharyngitis (9%), back pain (7%), and
arthralgia (5%).
Teva continues to evaluate the potential of laquinimod in
primary progressive MS (PPMS) and Huntington disease (HD) with two
other clinical trials unaffected by the results of the CONCERTO
trial. Complete data from the CONCERTO trial will be published in a
scientific journal and presented at a future medical meeting.
About CONCERTO:
CONCERTO is a multinational, multicenter, randomized,
double-blind, parallel-group, placebo-controlled study followed by
an active treatment period, to evaluate the efficacy, safety and
tolerability of two oral doses of laquinimod (0.6 mg/day or 1.2
mg/day) in subjects with RRMS. The higher-dose (1.2 mg) arm of the
trial was discontinued in January 2016. In addition to the primary
outcome measure of time to CDP after at least 3 months as measured
by change in EDSS, CONCERTO examined the impact of laquinimod (0.6
mg) on the secondary endpoints of change in brain volume from
baseline to month 15, time to first confirmed relapse and CDP
measured by EDSS after at least 6 and 9 months—all secondary
endpoints as compared to placebo.
About Laquinimod
Laquinimod is a once-daily oral, investigational, selective aryl
hydrocarbon receptor (AhR) activator targeting neurodegeneration
and inflammation with a novel mechanism of action being developed
for the treatment of relapsing -remitting MS (RRMS),
primary-progressive MS (PPMS) and Huntington disease.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by approximately 200
million patients in 100 markets every day. Headquartered in Israel,
Teva is the world’s largest generic medicines producer, leveraging
its portfolio of more than 1,800 molecules to produce a wide range
of generic products in nearly every therapeutic area. In specialty
medicines, Teva has the world-leading innovative treatment for
multiple sclerosis as well as late-stage development programs for
other disorders of the central nervous system, including movement
disorders, migraine, pain and neurodegenerative conditions, as well
as a broad portfolio of respiratory products. Teva is leveraging
its generics and specialty capabilities in order to seek new ways
of addressing unmet patient needs by combining drug development
with devices, services and technologies. Teva's net revenues in
2016 were $21.9 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 3 development for the treatment of relapsing remitting
multiple sclerosis. Also, laquinimod is in Phase 2 development for
the treatment of primary progressive multiple sclerosis and
Huntington's disease. Furthermore, commercial activities are
conducted for the tasquinimod, paquinimod and SILC projects. Please
visit www.activebiotech.com for more information.
This information is information that Active Biotech AB is
obliged to make public pursuant to the EU Market Abuse Regulation.
The information was submitted for publication, through the agency
of the contact person set out above, at 8 pm CET on May 5,
2017.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding Laquinimod, which are based on management’s current
beliefs and expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements.
Important factors that could cause or contribute to such
differences include risks relating to:
- challenges inherent in product research
and development, including uncertainty of clinical success;
- the uncertainty of obtaining regulatory
approval and commercial success of a new product;
- our specialty medicines business,
including: competition for our specialty products, especially
Copaxone®, our leading medicine, which faces competition from
existing and potential additional generic versions and
orally-administered alternatives; our ability to achieve expected
results from investments in our product pipeline, including
Laquinimod; competition from companies with greater resources and
capabilities; and the effectiveness of our patents and other
measures to protect our intellectual property rights;
- our business and operations in general,
including: our ability to develop and commercialize additional
pharmaceutical products; manufacturing or quality control problems,
which may damage our reputation for quality production and require
costly remediation; interruptions in our supply chain; disruptions
of our or third party information technology systems or breaches of
our data security; the restructuring of our manufacturing network,
including potential related labor unrest; the impact of continuing
consolidation of our distributors and customers; and variations in
patent laws that may adversely affect our ability to manufacture
our products;
and other factors discussed in our Annual Report on Form 20-F
for the year ended December 31, 2016 (“Annual Report”),
including in the section captioned “Risk Factors,” and in our other
filings with the U.S. Securities and Exchange Commission,
which are available at www.sec.gov and www.tevapharm.com.
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 statements or other information contained herein,
whether as a result of new information, future events or otherwise.
You are cautioned not to put undue reliance on these
forward-looking statements.
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version on businesswire.com: http://www.businesswire.com/news/home/20170505005740/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:United
StatesKevin C. Mannix, 215-591-8912orRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3) 926-7656orPR
Contacts:IsraelIris Beck Codner, 972 (3) 926-7687orUnited
StatesDenise Bradley, 215-591-8974orNancy Leone,
215-284-0213orActive Biotech ABTomas Leanderson,
+46-46-19-20-95orHans Kolam, +46-46-19-20-44
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