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.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 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
|
+-----------------------------------+-----------------------------------+
|Kev
in
Mannix |Denise Bradley |
|Teva North
America |Teva North America |
|(215) 591-8912
|(215) 591-8974
|
+-----------------------------------+-----------------------------------+
Ac
tive
Biotech Contacts:
+----------------+---------------+
|Tomas
Leanderson|+46-46-19-20-95|
+----------------+---------------+
|Göran Forsberg
|+46-46-19-11-54|
+----------------+---------------+
[HUG#1445408]
|