LUND, SWEDEN--(Marketwire - Oct 22, 2012) -
Newly Presented Data at 20(th) United European Gastroenterology (UEG)
Week
Conference Show Significant Impact of Laquinimod on Clinical Remission
versus
Placebo
Jerusalem, Israel and Lund, Sweden, October 22, 2012 - Teva
Pharmaceutical
Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI)
today announced the presentation of Phase IIa clinical data for
investigational
laquinimod in moderate to severe Crohn's disease (CD). The findings
demonstrated
that treatment with orally administered laquinimod 0.5 mg/day resulted
in a
robust, early and consistent effect on remission (48.3% vs. 15.9% of
patients,
respectively) and response rates (62.1% vs. 34.9% of patients,
respectively) in
patients with moderate-to-severe CD versus placebo. The data were reported
in an
oral presentation at the 20(th) United European Gastroenterology (UEG)
Week
conference
The full abstract can be found at:
https://uegw.congress-online.com/guest/ID6256b0a50b0e1f/AbstractView?ABSID=1088.
"Our developmental program for laquinimod has demonstrated that
the
immunomodulatory effects of this oral compound stand to apply to
multiple
autoimmune diseases, and data presented at UEG showed an impressive
impact on
clinical remission in Crohn's disease as early as one week of treatment,"
said
Dr. Michael Hayden, President of Global R&D and Chief Scientific
Officer for
Teva Pharmaceutical Industries, Ltd. "These data provide a solid
rationale for
potential future study of laquinimod in Crohn's disease."
The Phase IIa study evaluated the safety and efficacy of various
doses of
laquinimod (0.5, 1, 1.5, or 2 mg/day) compared to placebo in active CD
over
eight weeks of treatment with four weeks of follow up. No effect was
noted on
remission/response at higher doses. Additionally, laquinimod 0.5 mg and
1 mg
doses were generally well-tolerated, with adverse events similar to those
seen
with placebo. The data are currently undergoing further analysis and
evaluation
to finalize next steps in the CD clinical development plan.
ABOUT THE STUDY
The Phase IIa, multicenter, randomized, double-blind, placebo-controlled
trial
was designed to evaluate the safety and efficacy of laquinimod in 180
patients
with moderate to severe active CD, based on a CD Activity Index
(CDAI) of
220-450 and serum C-reactive protein (CRP) levels of >5mg/L or
mucosal
ulcerations evident on a recent endoscopy. The study tracked four dose
cohorts
who received laquinimod 0.5 mg/day, 1 mg/day, 1.5 mg/day, 2 mg/day, or
placebo
for eight weeks with four weeks follow-up. Approximately 45 patients
were
enrolled in each cohort in a 2:1 ration between laquinimod and
placebo.Stable
concomitant therapies and prior anti-tumor necrosis factor (TNF) use
among
patients was permitted in the study.
ABOUT LAQUINIMOD
Laquinimod is a novel oral immunomodulator under clinical development
for the
treatment of multiple sclerosis (MS), Crohn's disease (CD) and systemic
lupus
erythematosus (SLE or lupus). Human and animal models suggest laquinimod
exerts
its therapeutic effect by modulating the immune system cells, mainly
resulting
in a down regulation of pro-inflammatory cytokines.
ABOUT CROHN'S DISEASE
CD is a chronic inflammatory condition that affects the gastrointestinal
tract.
The symptoms of CD can vary significantly among afflicted individuals. The
main
gastrointestinal symptoms are abdominal pain, diarrhea, or weight loss.
CD can
also cause complications outside of the gastrointestinal tract such as
skin
rashes, arthritis, and inflammation of the eye.
The precise cause of CD is not known. CD is considered to be an
autoimmune
disease. This autoimmune activity produces inflammation in the
gastrointestinal
tract. CD is classified as an inflammatory bowel disease, IBD.
ABOUT TEVA
Teva Pharmaceutical Industries Ltd. (NASDAQ: 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 largest generic
drug
maker, with a global product portfolio of more than 1,300 molecules and a
direct
presence in about 60 countries. Teva's branded businesses focus on CNS,
oncology, pain, respiratory and women's health therapeutic areas as well as
biologics. Teva currently employs approximately 46,000 people around the
world
and reached $18.3 billion in net revenues in 2011.
ABOUT ACTIVE BIOTECH
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company with
focus on autoimmune/inflammatory diseases and cancer. Projects in or
entering
pivotal phase are laquinimod, an orally administered small molecule with
unique
immunomodulatory properties for the treatment of multiple sclerosis, TASQ
for
prostate cancer as well as ANYARA for use in cancer targeted therapy,
primarily
of renal cell cancer. In addition, laquinimod is in Phase II development
for
Crohn's and Lupus. Further projects in clinical development comprise the
two
orally administered compounds, 57-57 for SLE & Systemic Sclerosis and
RhuDex™
for RA. Please visit http://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 express the current
beliefs and expectations of management. Such statements 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 successfully develop and commercialize
additional
pharmaceutical products, the introduction of competing generic equivalents,
the
extent to which we may obtain U.S. market exclusivity for certain of our
new
generic products and regulatory changes that may prevent us from utilizing
exclusivity periods, potential liability for sales of generic products
prior to
a final resolution of outstanding patent litigation, including that
relating to
the generic version of Protonix®, the extent to which any manufacturing
or
quality control problems damage our reputation for high quality production,
the
effects of competition on sales of our innovative products, especially
Copaxone® (including potential generic and oral competition for
Copaxone®),
the impact of continuing consolidation of our distributors and customers,
our
ability to identify, consummate and successfully integrate acquisitions
(including the acquisition of Cephalon), interruptions in our supply chain
or
problems with our information technology systems that adversely affect our
complex manufacturing processes, intense competition in our specialty
pharmaceutical businesses, any failures to comply with the complex Medicare
and
Medicaid reporting and payment obligations, our exposure to currency
fluctuations and restrictions as well as credit risks, the effects of
reforms in
healthcare regulation, adverse effects of political or economical
instability,
major hostilities or acts of terrorism on our significant worldwide
operations,
increased government scrutiny in both the U.S. and Europe of our agreements
with
brand companies, dependence on the effectiveness of our patents and other
protections for innovative products, our ability to achieve expected
results
through our innovative R&D efforts, the difficulty of predicting U.S. Food
and
Drug Administration, European Medicines Agency and other regulatory
authority
approvals, uncertainties surrounding the legislative and regulatory pathway
for
the registration and approval of biotechnology-based products, potentially
significant impairments of intangible assets and goodwill, potential
increases
in tax liabilities resulting from challenges to our intercompany
arrangements,
our potential exposure to product liability claims to the extent not
covered by
insurance, the termination or expiration of governmental programs or tax
benefits, current economic conditions, any failure to retain key personnel
or to
attract additional executive and managerial talent, environmental risks and
other factors that are discussed in our Annual Report on Form 20-F and
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. This
information
was provided to the media for publication 3:00 p.m. CET on October 22,
2012.
PHASE IIa LAQUINIMOD TRIAL RESULTS SHOW POSITIVE DATA :
http://hugin.info/1002/R/1651043/532562.pdf
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originality of the information contained therein.
Source: Active Biotech via Thomson Reuters ONE
[HUG#1651043]