The GALA study evaluating glatiramer acetate 40 mg/1 ml administered
three times weekly met primary endpoint significantly reducing the
annualized relapse rate (ARR) by 34.4 percent compared to placebo
JERUSALEM--(BUSINESS WIRE)--Jun. 14, 2012--
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced
positive top-line results from the GALA (Glatiramer Acetate
Low-Frequency Administration) Phase III clinical trial assessing the
efficacy, safety and tolerability of 40 mg/1 ml glatiramer acetate
injection (GA) administered subcutaneously three times a week compared
to placebo in relapsing-remitting multiple sclerosis (RRMS) patients.
Study results showed that GA 40 mg/1 ml significantly reduced disease
activity, while maintaining a favorable safety and tolerability profile.
The one-year randomized, double-blind placebo-controlled study recruited
more than 1,400 patients at 155 multinational sites. Results showed that
GA 40 mg/1 ml met the study’s primary endpoint by significantly reducing
the annualized relapse rate (ARR) by 34.4 percent compared to placebo
(p<0.0001). Initial analysis of the data indicates that secondary
clinical endpoints were achieved, with the exception of reduction in
brain atrophy. Following the initial 12-month, placebo-controlled phase,
there will be an ongoing open-label extension of the trial.
“We are pleased with the results of this study that show the potential
of 40 mg/1 ml glatiramer acetate to offer patients an effective and safe
treatment option with COPAXONE® using a more convenient dosing regimen”
said Serge Stankovic, Senior Vice President of Clinical Research, Global
Branded R&D, Teva Pharmaceutical Industries Ltd. “We remain focused on
the continued research and development of products aimed at improving
the treatment experience for patients with MS.”
Further analyses of the GALA study data are ongoing, and detailed
results will be presented to the scientific community in the near
future. Teva plans to work with health authorities to determine next
steps.
The most commonly reported adverse events in the study were injection
site reactions, headaches and nasopharyngitis. The overall frequencies
of adverse events were comparable to those observed in the placebo group.
ABOUT THE STUDY
The multinational Phase III Glatiramer Acetate Low-frequency
Administration (GALA) trial was designed to examine the safety, efficacy
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 patients with
relapsing-remitting multiple sclerosis. The 40 mg/1 ml dose is higher
than the currently marketed 20 mg/1 ml daily COPAXONE®
(glatiramer acetate injection). 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:
United States
Kevin
C. Mannix, 215-591-8912
or
Israel
Tomer Amitai,
972-3-926-7656
or
PR:
United States
Denise Bradley,
215-591-8974
or
Israel
Shir Altay-Hagoel,
972-3-926-7590