New Formulation of COPAXONE® Offers Patients
and Their Physicians Ability to Dose Less Frequently
JERUSALEM--(BUSINESS WIRE)--Jan. 28, 2014--
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that
the U.S. Food and Drug Administration (FDA) has approved the Company’s
supplemental new drug application (sNDA) for three-times-a-week COPAXONE®
40mg/mL, a new dose of COPAXONE®. This new formulation will
allow for a less frequent dosing regimen administered subcutaneously for
patients with relapsing forms of multiple sclerosis (MS). In addition to
the newly approved dose, daily COPAXONE® 20 mg/mL will
continue to be available. The daily subcutaneous injection was approved
in 1996.
“The availability of three-times-a-week COPAXONE® 40 mg/mL is
a significant advancement for patients as they now have the option of
effective and safe treatment with COPAXONE®, while reducing
the number of injections by 60 percent,” said Omar Khan, M.D., Professor
of Neurology and Chair of the Department of Neurology, Wayne State
University School of Medicine, Detroit, MI. “Patients in the U.S. can
now benefit from an improved dosing regimen without compromising the
known benefits of COPAXONE®.”
The FDA approval is based on data from the Phase III Glatiramer Acetate
Low-Frequency Administration (GALA) study of more than 1400 patients,
which showed that a 40 mg/mL dose of COPAXONE® administered
subcutaneously three-times-a-week significantly reduced relapse rates at
12 months and demonstrated a favorable safety and tolerability profile
in patients with relapsing-remitting MS.
“For more than 20 years, Teva has pursued its multiple sclerosis
research with the goal of providing effective, safe and tolerable
therapies for MS patients,” said Larry Downey, President, North America
Specialty Medicines. “We have progressively invested in the innovation
of COPAXONE® in an effort to understand the needs and to ease
the burden of patients who live with relapsing forms of MS every day.
Today we are proud to continue to deliver on that investment by offering
the freedom to dose three-times-a-week with COPAXONE® 40
mg/mL.”
Three-times-a-week COPAXONE® 40mg/mL is available for
shipping to distribution outlets immediately, and will be available to
patients within days. Teva’s Shared Solutions® patient
support center has been scaled to support current patients as they
transition to the new, three-times-a-week 40mg/mL formulation. Patients
may call their doctors or Teva’s Shared Solutions®
(1-800-887-8100) and make a request. In addition, Shared Solutions®
provides 24/7 nurse support, financial and benefits investigation as
well as identification of pharmacy distribution options to enable
financial and physical access to COPAXONE®. Shared Solutions
also provides free injection training as well as ongoing compliance and
adherence support services.
About COPAXONE®
COPAXONE® (glatiramer acetate injection) is indicated for the
treatment of patients with relapsing forms of 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: www.CopaxonePrescribingInformation.com.
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: The following presentation
contains forward-looking statements, which express the current beliefs
and expectations of management. Such statements 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 medicines, 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 specialty, including 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 and license
products, our ability to reduce operating expenses to the extent and
during the timeframe intended by our cost restructuring program,
uncertainties relating to the replacement of and transition to a new
President & Chief Executive Officer, 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 settlement agreements with brand companies and liabilities
arising from class action litigation and other third-party claims
relating to such agreements, potential liability for sales of generic
medicines 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 medicines (and our ongoing FCPA
investigations and related matters), uncertainties surrounding the
legislative and regulatory pathways for the registration and approval of
biotechnology-based medicines, adverse effects of political or economic
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 resulting from challenges to our intercompany
arrangements, 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.
Teva Pharmaceutical Industries Ltd.
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or
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