JERUSALEM & LUND, Sweden--(BUSINESS WIRE)--May 5, 2017--
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170505005740/en/
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR Contacts:
United States
Kevin
C. Mannix, 215-591-8912
or
Ran Meir, 215-591-3033
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
PR Contacts:
Israel
Iris
Beck Codner, 972 (3) 926-7687
or
United States
Denise
Bradley, 215-591-8974
or
Nancy Leone, 215-284-0213
or
Active
Biotech AB
Tomas Leanderson, +46-46-19-20-95
or
Hans
Kolam, +46-46-19-20-44