Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced presentations of
several new studies at the World Congress on Treatment and Research in Multiple
Sclerosis in Montreal. New data will be presented on
COPAXONE®
(glatiramer acetate injection), a leading therapy for relapsing-remitting
multiple sclerosis (RRMS) treatment, covering early treatment with COPAXONE®,
long-term efficacy and safety.
In addition to Teva's post-marketing
studies of COPAXONE® in RRMS, the company will also present data on oral
laquinimod, which is now being investigated in 2 global Phase III studies (
http://www.tevaclinicaltrials.com) and on ATL/TV1102, a
second-generation VLA-4 inhibitor which has recently published positive results
from a Phase IIa study in RRMS patients.
Teva's extensive work and
continuous investments exemplified by these presentations represents the
Company's commitment to research that advances the understanding of MS and its
goal to seek improved therapies to address unmet needs within the category. Teva
R&D efforts in this area include a breadth of pipeline compounds focused on
various areas of discovery which hold promise for the treatment of MS.
Platform Presentations/Poster SessionsCOPAXONE®
Clinical Studies - Treatment with glatiramer acetate protects axons
in patients with clinically isolated syndromes: evidence from the PreCISe trial
(Presentation # 17, September 18 at 11:40 AM)
- Treatment with
glatiramer acetate delays conversion to clinically definite multiple sclerosis
(CDMS) in patients with clinically isolated syndrome (CIS): subgroup analyses
(Presentation # 32, September 18 at 3:30 PM)
- Continuous Long-Term
Immunomodulatory Therapy in Relapsing Multiple Sclerosis: Results from the 15
year Analysis of the US Prospective Open-label Study of Glatiramer Acetate
(Presentation # 44, September 18 at 3:30 PM)
- The impact of long-term
treatment with disease modifying therapy on disability progression in
relapsing-remitting multiple sclerosis patients (Presentation # 26, September 18
at 3:30 PM)
- Long-term follow-up of immunomodulatory therapies in early
relapsing-remitting multiple sclerosis (Presentation # 57, September 18 at 3:30
PM)
- Fatigue in relapsing-remitting multiple sclerosis - assessment of
clinical neuropsychological and immunological parameters in patients treated
with glatiramer acetate (Presentation # 478, September 19 at 3:30 PM) -
Glatiramer Acetate Reduces Multiple Sclerosis Severity: Analysis of Patients
from the US Pivotal Studies Using the Multiple Sclerosis Severity Scale
(Presentation # 454, September 19 at 3:30 PM)
- Short-term
Immunosuppression with Mitoxantrone Followed by Long-term Glatiramer Acetate vs.
Glatiramer Acetate Alone: Results at 36 Months in Patients with
Relapsing-Remitting Multiple Sclerosis (Presentation # 3, September 18 at 3:30
PM)
Laquinimod - Oral Laquinimod in Patients with
Relapsing-Remitting Multiple Sclerosis: 9-month double-blind active extension of
the Multi-center, Randomized, Double-blind, Parallel-group Placebo-controlled
Study (Presentation # 31, September 18 at 3:30 PM)
- Laquinimod given
before and after disease onset reduces inflammatory cell infiltration and
demyelination in experimental autoimmune encephalomyelitis (Presentation # 842,
September 19 at 3:30 PM)
ATL/TV1102 - VLA-4 antisense: an
oligonucleotide targeting VLA-4 mRNA (ATL1102) significantly reduces new active
lesions in patients with relapsing-remitting multiple sclerosis (Presentation #
81, late-breaking news, September 20 at 9:15 AM)
About COPAXONE®
COPAXONE® is now approved in 51 countries worldwide, including the
United States, Canada, Mexico, Australia, Israel, and all European countries. In
North America, COPAXONE® is marketed by Teva Neuroscience, Inc., which is a
subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA). In Europe,
COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis.
COPAXONE® is a registered trademark of Teva Pharmaceutical Industries Ltd.
COPAXONE® is indicated for the reduction of the frequency of relapses in
RRMS. The most common side effects of COPAXONE® are redness, pain, swelling,
itching, a lump or an indentation at the site of injection, weakness, infection,
pain, nausea, joint pain, anxiety, and muscle stiffness.
See additional
important information at
http://www.copaxone.com/pi/index.html or call
1-800-887-8100 for electronic releases. For hardcopy releases, please see
enclosed full prescribing information.
About Laquinimod
Laquinimod is a novel once-daily, orally administered
immunomodulatory compound that is being developed as a disease-modifying
treatment for RRMS. Active Biotech (OMX NORDIC:ACTI) developed laquinimod and
licensed it to Teva Pharmaceutical Industries, Ltd. in June 2004. A Phase IIb
study in 306 patients was recently published in
The Lancet and
demonstrated that an oral 0.6 mg dose of laquinimod, administered daily,
significantly reduced magnetic resonance images (MRI) disease activity by a
median of 60 percent versus placebo in RRMS patients. Laquinimod also showed
consistent and robust effect on all secondary MRI endpoints. 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. Over 460 MS patients have received laquinimod in various Phase
I-II clinical trials.
In addition to the efficacy that laquinimod has
shown in Phase II RRMS clinical trials, laquinimod has demonstrated potent
therapeutic efficacy in preclinical models of other autoimmune diseases such as
rheumatoid arthritis, insulin-dependent diabetes mellitus, Guillain Barr
Syndrome, lupus and Inflammatory Bowel Disease. The broad profile of efficacy in
animal models of inflammatory diseases suggests that laquinimod affects a
pivotal pathway of inflammation and autoimmunity. Teva expects to initiate the
clinical development of laquinimod for Crohn's disease and Lupus Nephritis in
the near future.
About ATL/TV1102 ATL/TV1102 is a second
generation antisense inhibitor of CD49d, a subunit of VLA-4 (Very Late
Antigen-4) originally developed by ISIS Pharmaceuticals, Inc. (Carlsbad,
California), and licensed to Teva Pharmaceutical Industries Ltd. by Antisense
Therapeutics Limited (ANP) (Australia).
VLA-4 is a clinically validated
target in the treatment of MS inhibiting the trafficking of inflammatory cells
to the site of inflammation. Antisense inhibition of VLA-4 has demonstrated
positive effects in a number of animal models of inflammatory disease including
MS
A Phase IIa trial studying the safety and efficacy of ALT/TV1102 in
RRMS patients was completed. The study showed a significant reduction of 54.4
percent in cumulative number of new active lesions in patients taking ATL/TV1102
for 8 weeks, compared to placebo, as measured by MRI. Teva is planning to
continue the development of this new molecule to confirm its efficacy and
safety.
About Teva Teva Pharmaceutical Industries Ltd.,
headquartered in Israel, is among the top 20 pharmaceutical companies in the
world and is the world's leading generic pharmaceutical company. The Company
develops, manufactures and markets generic and innovative human pharmaceuticals
and active pharmaceutical ingredients, as well as animal health pharmaceutical
products. Over 80 percent of Teva's sales are in North America and Europe.
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, competition from brand-name
companies that are under increased pressure to counter generic products, or
competitors that seek to delay the introduction of generic products, the impact
of consolidation of our distributors and customers, potential liability for
sales of generic products prior to a final resolution of outstanding patent
litigation, including that relating to the generic versions of
Allegra® ,
Neurontin®, Lotrel® and
Protonix®, the effects of competition on our innovative
products, especially Copaxone® sales, the impact of pharmaceutical industry
regulation and pending legislation that could affect the pharmaceutical
industry, the difficulty of predicting U.S. Food and Drug Administration,
European Medicines Agency and other regulatory authority approvals, the
regulatory environment and changes in the health policies and structures of
various countries, our ability to achieve expected results though our innovative
R&D efforts, our ability to successfully identify, consummate and integrate
acquisitions, including the pending acquisition of Barr Pharmaceuticals Inc.,
potential exposure to product liability claims to the extent not covered by
insurance, dependence on the effectiveness of our patents and other protections
for innovative products, significant operations worldwide that may be adversely
affected by terrorism, political or economical instability or major hostilities,
supply interruptions or delays that could result from the complex manufacturing
of our products and our global supply chain, environmental risks, fluctuations
in currency, exchange and interest rates, and other factors that are discussed
in this report and in our other filings with the U.S. Securities and Exchange
Commission ("SEC").
Teva Pharmaceutical Industries
