Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Active
Biotech (NASDAQ OMX NORDIC:ACTI) today announced new follow-up data
evaluating the clinical safety of laquinimod in patients with
relapsing-remitting multiple sclerosis (RRMS) who were treated with
laquinimod in Phase II, Phase III and open-label extension studies
for two or more years. The pooled safety analysis of the Phase II
LAQ/5063 and the Phase III ALLEGRO and BRAVO extension studies
supports findings observed in the core studies where currently
identified risks were observed within the first months of
laquinimod treatment. These data will be presented as part of a
platform presentation, September 12, 2014, at the MS Boston 2014:
Joint ACTRIMS-ECTRIMS Meeting being held in Boston,
Massachusetts.
“These data may be important as they further support the
clinical safety profile of laquinimod,” said Michael Hayden, M.D.,
Ph.D., President of Global R&D and Chief Scientific Officer at
Teva Pharmaceutical Industries, Ltd. “We believe laquinimod may
have the potential to help physicians address certain gaps within
the MS treatment paradigm as a potential therapeutic option when
considering the benefits and risks in a longer-term setting.”
In the pooled safety analysis, rates of adverse events (AEs) and
serious AEs were lower in the open-label extensions than in the
core studies and less than three percent of patients discontinued
treatment due to AEs during these extensions. Additionally, shifts
to potentially significant laboratory values were considerably
lower in patients exposed to at least two years of laquinimod
(1.18% reached >3xULN ALT vs. 4.72% for laquinimod and 2.6% for
placebo during the core study). The safety analysis included
patients exposed to laquinimod 0.6 mg for two or more years
(n=1009), with a mean exposure of 3.7 (±1.0) years, in the
double-blind phase and open-label extensions of the Phase II
LAQ/5063 and the Phase III ALLEGRO and BRAVO trials.
“In this pooled analysis, laquinimod has shown to be safe for
patients taking the treatment for two or more years, which supports
the safety profile of laquinimod when used in a longer-term
setting,” said Professor Giancarlo Comi, Director of the Department
of Neurology and Institute of Experimental Neurology at the San
Raffaele Scientific Institute, Vita-Salute San Raffaele University,
Italy. “In a separate analysis, we were pleased to see that when
used in a longer-term setting, laquinimod continued to show a
favorable effect on relapses and confirmed disability progression,
maintaining the benefits previously seen in Phase III studies.”
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) and progressive
forms of MS. The global Phase III clinical development program
evaluating laquinimod in MS includes two pivotal studies, ALLEGRO
and BRAVO (both 0.6mg). A third Phase III laquinimod trial,
CONCERTO, is evaluating two doses of the investigational product
(0.6mg and 1.2mg) in approximately 2,100 patients for up to 24
months. The primary outcome measure will be time to confirmed
disability progression as measured by the EDSS.
In the ALLEGRO and BRAVO trials, adverse reactions 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.
In addition to the MS clinical studies, studies are planned to
evaluate the efficacy, safety and tolerability of laquinimod in
other neurodegenerative diseases including Huntington’s
disease.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) is a leading
global pharmaceutical company, committed to increasing access to
high-quality healthcare by developing, producing and marketing
affordable generic drugs as well as innovative and specialty
pharmaceuticals and active pharmaceutical ingredients.
Headquartered in Israel, Teva is the world's leading generic drug
maker, with a global product portfolio of more than 1,000
molecules, sold in more than 100 countries, and with a direct
presence in about 60 countries. Teva's specialty medicine
businesses focus on CNS, including pain, respiratory, oncology, and
women's health therapeutic areas as well as biologics. Teva
currently employs approximately 45,000 people around the world and
reached $20.3 billion in net revenues in 2013.
About Active Biotech
Active Biotech AB (NASDAQ OMX NORDIC:ACTI) is a biotechnology
company with focus on autoimmune/inflammatory diseases and cancer.
In pivotal phase is laquinimod, an orally administered small
molecule with unique immunomodulatory properties for the treatment
of multiple sclerosis. Also tasquinimod for the treatment of
prostate cancer, with a unique mode of action, is in pivotal phase.
In addition, laquinimod has concluded Phase II development for
Crohn's and Lupus. The company has two additional projects in
clinical development, ANYARA primarily for the treatment of renal
cell cancer and the orally administered compound paquinimod (57-57)
for systemic sclerosis. Please visit www.activebiotech.com for more
information.
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. Such
statements 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 generic versions); 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 successfully pursue and consummate suitable
acquisitions or licensing opportunities; the extent to which any
manufacturing or quality control problems damage our reputation for
quality production and require costly remediation; our potential
exposure to product liability claims that are not covered by
insurance; 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 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; uncertainties related to our recent
management changes; the effects of increased leverage and our
resulting reliance on access to the capital markets; any failure to
recruit or retain executives or other key personnel; adverse
effects of political or economical 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;
decreased opportunities to obtain U.S. market exclusivity for
significant new generic products; potential liability for sales of
generic products prior to a final resolution of outstanding patent
litigation; any failures to comply with complex Medicare and
Medicaid reporting and payment obligations; the impact of
continuing consolidation of our distributors and customers;
significant impairment charges relating to intangible assets and
goodwill; the potential for significant 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, 2013 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. This information was provided to the media for
publication 02:00 pm CET on September 12, 2014.
Teva Pharmaceutical Industries Ltd.IR:United StatesKevin C.
Mannix, 215-591-8912orRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR:IsraelIris Beck Codner, 972 (3)
926-7687orUnited StatesDenise Bradley,
215-591-8974orNancy Leone, 215-284-0213orActive
BiotechTomas Leandersen, +46-46-19-20-95orHans Kolam,
+46-46-19-20-44
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