- Glatiramer acetate (GA) 40 mg/1 ml three times weekly significantly
reduced annualized relapse rates (ARR)
- Significant
reductions in new/enlarging T2 and gadolinium-enhancing (GdE) lesions in
RRMS patients also observed
- New data being presented at
late-breaking news session at the 28th ECTRIMS
congress
JERUSALEM--(BUSINESS WIRE)--Oct. 10, 2012--
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced data
from the Phase III Glatiramer Acetate Low-Frequency Administration
(GALA) study. The GALA study was designed to evaluate the efficacy,
safety and tolerability of an investigational dosing regimen of
glatiramer acetate (GA), the therapeutic agent in COPAXONE®
(glatiramer acetate injection), which is indicated for the treatment of
relapsing-remitting multiple sclerosis (RRMS). Detailed study results
will be presented at the 28th Congress of the European
Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in
Lyon, France during the late-breaking news parallel session on October
13, 2012.
“We are excited about the potential to offer RRMS patients another safe
and effective treatment option for this chronic and debilitating
disease,” said Dr. Michael Hayden, President of Global R&D and Chief
Scientific Officer for Teva Pharmaceutical Industries Ltd. “The GALA
study demonstrates Teva’s ongoing commitment to the research and
development of products aimed at meeting the specific needs of the RRMS
community.”
In the GALA study, a one-year randomized, double-blind, placebo
controlled study, GA 40 mg/1 ml significantly reduced annualized relapse
rates (ARR) by 34.4 percent (p<0.0001) versus placebo. Additionally, a
significant 34.4 percent reduction in the cumulative number of new and
enlarging T2 lesions (p<0.0001) and a significant 44.8 percent reduction
in the cumulative number of gadolinium-enhancing (GdE) legions
(p<0.0001) was observed in patients treated with GA 40 mg/1 ml versus
placebo. At 12 months, there was no significant difference in percent
change of brain volume between GA and placebo. Discontinuation rates
among the GA and placebo patient cohorts were comparable.
GA 40 mg/1 ml demonstrated a favorable safety and tolerability profile.
The overall frequency of adverse events was comparable to those observed
in the placebo group. The most commonly reported adverse events were
injection site reactions, headaches and nasopharyngitis.
“The GALA study was aimed at evaluating an alternative dosing regimen of
COPAXONE® (20 mg/1 ml glatiramer acetate daily subcutaneous
injection), an RRMS therapy that physicians and patients have relied on
for almost two decades,” said lead study author, Dr. Omar Khan,
Professor and Interim Chair, Department of Neurology and Director,
Multiple Sclerosis Clinical Research Center & Image Analysis Laboratory,
Wayne State University School of Medicine, Detroit, MI. “The results
demonstrate that GA 40 mg/1 ml injected three times weekly has the
potential to provide an alternative therapeutic option for patients with
RRMS, offering a higher dose of GA at a reduced injection frequency to
improve patient experience, without compromising efficacy or safety.”
Further analyses are ongoing in an open-label extension of the trial
through pre-planned follow-up beyond the initial 12-month
placebo-controlled phase. Teva plans to work with health authorities to
determine next steps.
About the GALA Study
The multinational Phase III Glatiramer Acetate Low-frequency
Administration (GALA) trial was designed to examine the efficacy, safety
and tolerability of glatiramer acetate (GA) 40 mg/1 ml injection
administered three times a week compared to placebo in a randomized
double-blind placebo-controlled design in over 1,400 patients with
relapsing-remitting multiple sclerosis. Currently, COPAXONE®
(glatiramer acetate injection) is marketed in a 20 mg/1 ml daily dose.
The primary endpoint of the study is the total number of confirmed
relapses during a 12-month, placebo-controlled phase.
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 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 Contacts:
United States
Kevin
C. Mannix, 215-591-8912
Joseph Marczely, 267-468-4281
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
PR Contacts:
Israel
Hadar
Vismunski-Weinberg, 972 (3) 926-7687
or
United
States
Denise Bradley, 215-591-8974