Highlights Include Late-Breaking Presentation of the Phase III GALA
Results Evaluating Glatiramer Acetate 40 mg/1 ml
JERUSALEM--(BUSINESS WIRE)--Oct. 8, 2012--
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced that
key data from the Company’s multiple sclerosis (MS) franchise will be
featured at the 28th Congress of the European Committee for
Treatment and Research in Multiple Sclerosis (ECTRIMS) in Lyon, France,
October 10-13, 2012. Data presentations will provide new insights on
COPAXONE® (glatiramer acetate injection), the world’s leading
relapsing-remitting multiple sclerosis (RRMS) treatment, and Teva’s
investigational oral compound laquinimod, as well as results from the
ongoing TOP MS and NARCOMS studies.
"For more than 20, years Teva has been at the forefront of MS research
and development focused on providing effective and safe treatments aimed
at meeting the needs of patients’ living with this complex, often
debilitating disease,” said Dr. Michael Hayden, President of Global R&D
and Chief Scientific Officer for Teva Pharmaceutical Industries Ltd.
“The data being presented at ECTRIMS demonstrate our ongoing commitment
to enhancing the treatment experience for RRMS patients and advancing
science to assist neurologists in making appropriate treatment
decisions, especially as the market continues to evolve.”
In addition to the data being presented at the Congress, Teva will host
a satellite symposium, “New Concepts in MS Pathology Shed Light on MS
Treatment Approaches” on Thursday, October 11, 2012 from 19:15 - 20:15
CET. Teva will also host a media event for credentialed journalists on
Thursday, October 11, 2012 at 12:00 CET focused on advancements made in
RRMS and future considerations for treatment.
Teva-Sponsored Data Highlights Include:
Glatiramer Acetate:
The multinational randomized, double-blind placebo-controlled Phase III
Glatiramer Acetate Low-frequency Administration (GALA) study examined
the efficacy, safety and tolerability of an investigational formulation
of glatiramer acetate 40 mg/1 ml administered three times a week
compared to placebo in a randomized, double-blind placebo-controlled
design in patients with RRMS. A late-breaking news parallel session will
present detailed clinical data on October 13, 2012, while a poster
presentation will analyze baseline patient demographics for this trial.
Key posters include:
-
[P 912] A multinational, multicenter, randomized, parallel-group
study to access efficacy, safety and tolerability of Glatiramer
Acetate 40 mg injection three times a week in subjects with RRMS:
Baseline Patient Characteristics of the GALA study (Poster Session
2: Immunomodulation, October 12, 15:30 - 17:00 CET) O. Khan, P.
Rieckmann, A. Boyko, K. Selmaj, R. Zivadinov (Detroit, US; Bamberg,
DE; Moscow, RU; Lodz, PL; Buffalo, US)
-
[166] A phase 3 trial to assess the efficacy and safety of
glatiramer acetate injections 40mg administered 3 times a week
compared to placebo (Parallel Session 13: Late Breaking News,
October 13, 8:30 – 8:45 CET) O. Khan, P. Rieckmann, A. Boyko, K.
Selmaj, R. Zivadinov (Detroit, US; Bamberg/Erlangen, DE; Moscow, RU;
Lodz, PL; Buffalo, US)
Laquinimod:
Laquinimod is an oral, once-daily investigational central nervous
system (CNS)-active immunomodulator with a novel mechanism of action in
development for the treatment of RRMS. Multiple presentations at ECTRIMS
further demonstrate the clinical benefits of this unique compound.
Ongoing analyses from the open-label extension phase of the ALLEGRO
trial assessing the effect on disease course in patients treated with
laquinimod for three years, as well as in patients originally treated
with placebo and switched to laquinimod treatment for one year, may
provide further possible evidence surrounding the effectiveness of the
compound in decreasing relapse rates. Further analyses on other
clinical endpoints such as disability and safety will be discussed.
Results from an additional study using several magnetic resonance
imaging (MRI) techniques sensitive to irreversible tissue damage
such as measurements of brain volume or magnetic transfer ratio
(MTR) were consistent with the positive impact on disability
progression demonstrated with the therapy. Key posters include:
-
[P 516] Oral laquinimod in patients with relapsing-remitting
multiple sclerosis: Clinical effects at 36 months in the open-label
extension phase of the ALLEGRO study (Poster Session 1: Long-term
Treatment Monitoring, October 11, 15:30 – 17:00 CET) G. Comi, D.
Jeffery, L. Kappos, X. Montalban, A.N. Boyko, M.A. Rocca, M. Filippi
on behalf of the ALLEGRO Study Group
-
[P 762] Assessing prognostic factors of severe relapse requiring
hospitalisation and/or IV methylprednisolone in RRMS treated with
placebo or laquinimod: pooled analysis from the ALLEGRO and BRAVO
trials (Poster Session 2: Economic Burden, October 12, 15:30 –
17:00 CET) C.A. Carroll, P. Lindgren, A. Lang on behalf of the
Allegro & BRAVO Study Group
-
[P 861] Evidence for a neuroprotective effect of oral laquinimod in
relapsing remitting multiple sclerosis (Poster Session 2: Imaging,
October 12, 15:30 – 17:00 CET) M. Filippi, M.A. Rocca, N. De
Stefano, D. Jeffery, L. Kappos, X. Montalban, A.N. Boyko, G. Comi on
behalf of the ALLEGRO Study Group
Multiple Sclerosis:
Results from the Therapy Optimization in Multiple Sclerosis (TOP MS)
study, the largest prospective Phase IV study conducted in MS, provide
insight into the impact of adherence to therapy as well as the effect of
progression of symptoms on MS patients’ health outcomes and daily
activities. Presentation of data will show that better adherence to
disease-modifying treatment (DMT) was associated with fewer relapses, as
measured by the medication possession ratio (MPR). Additionally,
independent of non-adherence to therapy, prior use of one or more MS
therapies was associated with increased risk of relapse. In terms of MS
symptom effects, a separate presentation will show that change in
fatigue severity scale (FSS) was observed as a significant predictor of
percent time missed from work. Key posters include:
-
[P 260] Relationship between MS therapy adherence and relapse
episodes (Poster Session 1: Databases and Pharmacoepidemiology,
October 11, 15:30 – 17:00 CET) T. Leist, H. Zwibel, M. Schwartz, B.
Cohen, M. Tullman, P. K. Coyle on behalf of the TOP MS Steering
Committee
-
[P 1035] Predictors of change in work productivity and activity
impairment scores (Poster Session 2: Comprehensive Care and
Rehabilitation) M. Tullman, T. Leist, H. Zwibel, B. Cohen, P.K.
Coyle, M. Lage on behalf of the TOP MS Study Steering Committee
The North American Research Committee on Multiple Sclerosis (NARCOMS) is
a global longitudinal MS registry that collects information regarding
the long-term effects of DMT among an active database of over 35,000 MS
patients. Researchers analyzed data from the registry to describe the
disease characteristics of MS patients who have continuously taken the
same DMT for a minimum of five years and to evaluate the likelihood of
changes in Patient-Determined Disease Steps (PDDS) and Performance
Scales (PS). Results will reveal factors that may inform treatment
decisions among clinicians. Key posters include:
-
[P 698] Comparative effectiveness of long-term users of
disease-modifying therapy (Poster Session 2: Epidemiology, October
12, 15:30 – 17:00 CET) A. Salter, Y. Tang, L. Hornung, S. Kolodny,
D. Hurtukova, S. Glenski, S. Cofield, X. Zhang, G. Cutter (Birmingham,
Kansas City, US)
About COPAXONE®
COPAXONE® (glatiramer acetate injection) is indicated for the
reduction of the frequency of relapses in relapsing-remitting multiple
sclerosis, including patients who have experienced a first clinical
episode and have MRI features consistent with multiple sclerosis.
The most common side effects of COPAXONE® are redness, pain,
swelling, itching, or a lump at the site of injection, flushing, rash,
shortness of breath, and chest pain.
See additional important information at: http://www.sharedsolutions.com/redirect/PrescribingInformation.pdf.
For hardcopy releases, please see enclosed full prescribing information.
COPAXONE® is now approved in more than 50 countries
worldwide, including the United States, Russia, Canada, Mexico,
Australia, Israel, and all European countries.
About Laquinimod
Laquinimod is an oral, once-daily CNS-active immunomodulator with a
novel mechanism of action being developed for the treatment of MS. In
animal models, laquinimod crosses the blood-brain barrier to potentially
have a direct effect on the neurodegenerative processes of MS. The
global Phase III clinical development program evaluating oral laquinimod
in MS includes two pivotal studies, ALLEGRO and BRAVO. A third Phase III
laquinimod trial, CONCERTO, will evaluate two doses of the
investigational product (0.6mg and 1.2mg) in approximately 1,800
patients for up to 24 months. The primary outcome measure will be
confirmed disability progression as measured by the Expanded Disability
Status Scale (EDSS).
In addition to the MS clinical studies, laquinimod is currently in Phase
II of development for Crohn's disease and Lupus.
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
1,300 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.
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, including statements relating to the results
of the GALA phase III trial and the potential efficacy or future market
or marketability of glatiramer acetate 40 mg/1 ml. Following further
analysis, Teva's interpretation of the results could differ materially
depending on a number of factors, and we caution investors not to place
undue reliance on the forward-looking statements contained in this press
release as there can be no guarantee that the results from the phase III
trial discussed in this press release will be confirmed upon full
analysis of the results of the trial and additional information relating
to the safety, efficacy or tolerability of glatiramer acetate 40 mg/1 ml
may be discovered upon further analysis of data from the phase III
trial. Even if the results described in this release are confirmed upon
full analysis of the GALA study, we cannot guarantee that glatiramer
acetate 40 mg/1 ml will be approved for marketing in a timely manner, if
at all, by regulatory authorities in the EU or in the U.S. 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 innovative
orally-administered alternatives, as well as from potential generic
equivalents), competition for our generic products (including from other
pharmaceutical companies and as a result of increased governmental
pricing pressures), competition for our specialty pharmaceutical
businesses, our ability to achieve expected results through our
innovative R&D efforts, the effectiveness of our patents and other
protections for innovative products, decreasing opportunities to obtain
U.S. market exclusivity for significant new generic products, our
ability to identify, consummate and successfully integrate acquisitions
(including the acquisition of Cephalon), the effects of increased
leverage as a result of the acquisition of Cephalon, the extent to which
any manufacturing or quality control problems damage our reputation for
high quality production and require costly remediation, our potential
exposure to product liability claims to the extent not covered by
insurance, increased government scrutiny in both the U.S. and Europe of
our agreements with brand companies, 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®,
our exposure to currency fluctuations and restrictions as well as credit
risks, the effects of reforms in healthcare regulation and
pharmaceutical pricing and reimbursement, any failures to comply with
complex Medicare and Medicaid reporting and payment obligations,
governmental investigations into sales and marketing practices
(particularly for our specialty pharmaceutical products), uncertainties
surrounding the legislative and regulatory pathway for the registration
and approval of biotechnology-based products, 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 our information technology systems that
adversely affect our complex manufacturing processes, any failure to
retain key personnel (including Cephalon employees) or to attract
additional executive and managerial talent, the impact of continuing
consolidation of our distributors and customers, variations in patent
laws that may adversely affect our ability to manufacture our products
in the most efficient manner, potentially significant impairments of
intangible assets and goodwill, potential increases in tax liabilities,
the termination or expiration of governmental programs or tax benefits,
environmental risks and other factors that are discussed in our Annual
Report on Form 20-F for the year ended December 31, 2011 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 the Company undertakes no obligation to update or revise any
forward-looking statement, whether as a result of new information,
future events or otherwise.
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
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Kevin
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or
Joseph Marczely, 267-468-4281
or
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Tomer
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