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Glatiramer acetate (GA) 20 mg daily associated with stable disease
activity over the course of the twenty-year study presented at the 29th
ECTRIMS congress
JERUSALEM--(BUSINESS WIRE)--Oct. 3, 2013--
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced further
results from a long-term, open-label extension study of glatiramer
acetate (GA). The extension study was designed to evaluate the long-term
neurologic disease course, and the safety and efficacy of glatiramer
acetate 20 mg daily, the therapeutic agent in COPAXONE®
(glatiramer acetate injection), which is indicated for reduction of the
frequency of relapses in patients with relapsing-remitting multiple
sclerosis (RRMS). Detailed study results will be presented at the 29th
Congress of the European Committee for Treatment and Research in
Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark during poster
session P577 on October 3, 2013.
“To our knowledge, glatiramer acetate is the only treatment for multiple
sclerosis that has been prospectively studied for nearly two decades in
a continuously monitored, long-term study,” said Dr. Michael Hayden,
President of Global R&D and Chief Scientific Officer for Teva
Pharmaceutical Industries Ltd.
In this analysis of 74 patients, the cumulative annualized relapse rate
(ARR) over the study period was 0.2, with 24.3 percent of patients
remaining relapse-free through the entire observation period.
Additionally, 63.3 percent of enrolled patients stayed below EDSS 4,
while 79.5 percent stayed below EDSS 6 throughout the course of the
study. Advancement to secondary progressive MS (SPMS), defined by a
greater than 1.0-point EDSS progression (or greater than 0.5 for
patients with baseline scores greater than 6) sustained for greater than
or equal to 12 months without relapse, was seen in 35 patients (47
percent). Adverse events (AEs) leading to study discontinuation with
incidence greater than one percent over the 20-year observation period
were largely related to site reactions, while incidence of serious AEs
were notably low, with no unexpected findings.
ABOUT THE OPEN-LABEL EXTENSION STUDY
The open-label extension study is a long-term clinical analysis of
patients that participated in the original 36-month, randomized
placebo-controlled U.S. Glatiramer Acetate Trial. The objective of the
extension study was to evaluate the long-term neurologic disease course,
and the safety and efficacy of glatiramer acetate 20 mg daily, in
patients with relapsing-remitting multiple sclerosis. Ongoing patients
in this study were continuously treated with glatiramer acetate 20 mg
daily for a mean of 19.3 years (SD=1.3, range 18-21) with an average
disease duration of 27.3 years. Baseline assessments for each patient in
this pooled analysis were taken at the start of GA therapy.
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.
Important Safety Information about COPAXONE®
Patients allergic to glatiramer acetate or mannitol should not take
COPAXONE®. Some patients report a short-term reaction right
after injecting COPAXONE®. This reaction can involve flushing
(feeling of warmth and/or redness), chest tightness or pain with heart
palpitations, anxiety, and trouble breathing. These symptoms generally
appear within minutes of an injection, last about 15 minutes, and go
away by themselves without further problems. During the postmarketing
period, there have been reports of patients with similar symptoms who
received emergency medical care. If symptoms become severe, patients
should call the emergency phone number in their area. Patients
should call their doctor right away if they develop hives, skin rash
with irritation, dizziness, sweating, chest pain, trouble breathing, or
severe pain at the injection site. If any of the above occurs, patients
should not give themselves any more injections until their doctor tells
them to begin again. Chest pain may occur either as part of the
immediate postinjection reaction or on its own. This pain should only
last a few minutes. Patients may experience more than one such episode,
usually beginning at least one month after starting treatment. Patients
should tell their doctor if they experience chest pain that lasts for a
long time or feels very intense. A permanent indentation under the skin
(lipoatrophy or, rarely, necrosis) at the injection site may occur, due
to local destruction of fat tissue. Patients should follow proper
injection technique and inform their doctor of any skin changes. 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. These are not all of the possible
side effects of COPAXONE®. For a complete list, patients
should ask their doctor or pharmacist. Patients should tell their doctor
about any side effects they have while taking COPAXONE®.
Patients are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.
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
1,000 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 $20.3 billion
in net revenues in 2012.
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
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 purported 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, the effects of increased leverage as a result of
recent acquisitions, 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, 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 pathways for the registration and approval of
biotechnology-based products, adverse effects of political or economical
instability, corruption, 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
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, 2012 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.