JERUSALEM & LUND, Sweden--(BUSINESS WIRE)--Sep. 12, 2014--
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.
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
United States
Kevin
C. Mannix, 215-591-8912
or
Ran Meir, 215-591-3033
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
PR:
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
Tomas Leandersen, +46-46-19-20-95
or
Hans
Kolam, +46-46-19-20-44