ORAL LAQUINIMOD DEMONSTRATED SUSTAINED EFFICACY AND SAFETY IN PATIENTS WITH MULTIPLE SCLEROSIS
Sep 20, 2010 15:02 (CEST)
Website:www.tevapharm.com www.activebiotech.com
* Positive benefit-risk profile of laquinimod sustained in Phase II extension
study
* 52 percent reduction (p=0.0006) in mean number of gadolinium-enhancing (GdE)
T1 lesions
* Results from pivotal Phase III studies, ALLEGRO and BRAVO, anticipated in
2011
Jerusalem, Israel, September 20, 2010 -- Teva Pharmaceutical Industries Ltd.
(NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced
results from a 36-week active extension study evaluating two doses of
laquinimod, an investigational, once-daily oral immunomodulator, for the
treatment of relapsing remitting multiple sclerosis (RRMS). The double-blind,
multinational study demonstrated the sustained positive benefit-risk profile of
laquinimod, which was shown to reduce Gd-enhancing (GdE) T1 lesions, while
maintaining a good safety profile. These findings were published online by the
journal Multiple Sclerosis.
Patients originally randomized to placebo in the core Phase II study, LAQ/5062,
(published in The Lancet*) were re-randomized to either 0.3 mg or 0.6 mg
laquinimod for the extension study, while patients originally randomized to
active treatment continued with the same treatment assignment for an additional
36 weeks. Patients switching from placebo to an active treatment of laquinimod
showed a 52 percent reduction in the mean number of GdE lesions (p=0.0006), a
marker of disease activity. In patients initially randomized to 0.6 mg
laquinimod, the reduction of MRI activity was maintained. Additionally,
treatment with laquinimod was associated with a sustained reduction in relapse
rate, no evidence of immunosuppression and good safety and tolerability profile.
"The results from this extension study confirm the balanced efficacy, safety,
and tolerability profile seen with laquinimod to date," explains Giancarlo Comi,
M.D., the lead study author and the Director of the Department of Neurology and
Institute of Experimental Neurology at the University Vite Salute, San Raffaele.
"We look forward to the results of the Phase III ALLEGRO and BRAVO studies in
2011, and the potential of this novel agent to address the current unmet need
for MS patients seeking a safe, effective and well tolerated oral therapy."
Laquinimod received Fast Track designation from the U.S. Food and Drug
Administration (FDA) in February 2009. Two global Phase III clinical studies,
ALLEGRO and BRAVO are currently ongoing, with results anticipated during Q1 and
Q3 2011, respectively.
* Comi G. et al. (2008). Effect of laquinimod on MRI-monitored disease activity
in patients with relapsing remitting multiple sclerosis: a multicentre,
randomized, double-blind, placebo-controlled phase IIb study. The Lancet;
371:2085-92.
ABOUT THE STUDY
The multinational, double-blind, 36-week extension of the placebo-controlled
Phase IIb laquinimod study was conducted in 9 countries at 51 sites. Two hundred
thirty-nine (93 percent) patients completed the extension phase of the study and
222 (87.1 percent) had a final scan. GdE lesions were significantly reduced for
patients switching from placebo to 0.3 or 0.6mg doses (52 percent, p = 0.0006).
In patients initially randomized to 0.6 mg, the reduction of MRI activity
observed in the placebo-controlled phase was maintained in the extension. The
proportion of GdE-free patients for those who switched from placebo increased
from a baseline of 31 percent to 47 percent at the end of the extension phase (p
= 0.01). No new adverse events emerged during the extension study. The
incidence rate of liver enzymes elevation observed in the LAQ/5062 core study
decreased in the extension phase.
ABOUT LAQUINIMOD
Laquinimod is an investigational, novel, once-daily oral immunomodulator being
developed as a disease-modifying treatment for RRMS. Active Biotech developed
laquinimod and licensed it to Teva Pharmaceutical Industries, Ltd. in June
2004. A Phase IIb study in 306 patients was published in The Lancet and
demonstrated that an oral 0.6 mg dose of laquinimod, administered daily,
significantly reduced MRI disease activity by 60 percent versus placebo in RRMS
patients. In addition, the study showed a favorable trend toward reducing annual
relapse rates and the number of relapse-free patients compared with placebo.
Treatment was well tolerated, with only some transient and dose-dependent
increases in liver enzymes reported.
Two pivotal, global Phase III studies of laquinimod for the treatment of RRMS,
ALLEGRO and BRAVO, are nearing completion. ALLEGRO, a 24-month multinational,
double-blind, placebo-controlled study, designed to evaluate the efficacy,
safety and tolerability of laquinimod versus placebo in the treatment of RRMS,
enrolled 1,106 patients and data from the study are expected in Q1 2011. BRAVO,
a multinational, multi-center, randomized, parallel-group study designed to
evaluate laquinimod compared to placebo, as well as to provide risk-benefit data
for laquinimod compared to a currently available injectable treatment, Avonex®,
has enrolled 1,332 patients and will be complete in Q3 2011.
In addition to the ongoing RRMS clinical studies, laquinimod is currently in
Phase II development for Crohn's disease and Lupus, and is being studied in
other autoimmune diseases.
ABOUT TEVA
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top
15 pharmaceutical companies in the world and is the leading generic
pharmaceutical company. The company develops, manufactures and markets generic
and innovative pharmaceuticals and active pharmaceutical ingredients. Over 80
percent of Teva's sales are in North America and Western Europe.
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(TM)
for RA. Please visitwww.activebiotech.comfor 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 versions of Neurontin®, Lotrel®, Protonix® and Yaz®, 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 ratiopharm), 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 this report and in our other filings with
the U.S. Securities and Exchange Commission ("SEC").
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. The information
was submitted for publication at 3 pm CEST on September 20, 2010.
# # #
Teva Contacts:
+-----------------------------------+-----------------------------------+
|Investor Relations: |Media: |
|Elana Holzman |Yossi Koren |
|Teva Pharmaceutical Industries Ltd.|Teva Pharmaceutical Industries Ltd.|
|972 (3) 926-7554 |972 (3) 926-7590 |
+-----------------------------------+-----------------------------------+
|Kevin Mannix |Denise Bradley |
|Teva North America |Teva North America |
|(215) 591-8912 |(215) 591-8974 |
+-----------------------------------+-----------------------------------+
Active Biotech Contacts:
+----------------+---------------+
|Tomas Leanderson|+46-46-19-20-95|
+----------------+---------------+
|Göran Forsberg |+46-46-19-11-54|
+----------------+---------------+
[HUG#1445408]
ORAL LAQUINIMOD DEMONSTRATED SUSTAINED EFFICACY AND SAFETY IN PATIENTS WITH MULTIPLE SCLEROSIS:
http://hugin.info/1002/R/1445408/388790pdf
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Source: Active Biotech via Thomson Reuters ONE
