JERUSALEM & OSAKA, Japan--(BUSINESS WIRE)--Dec. 4, 2013--
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Takeda
Pharmaceutical Company Limited (Takeda) today announced the signing
earlier this year of an agreement in which Teva licensed to Takeda the
right to commercialize Teva’s innovative glatiramer acetate ( active
ingredient) formulation for the treatment of multiple sclerosis, in
Japan. Teva and Takeda are currently working on further agreements in
connection with the implementation of this license.
Developed by Teva, glatiramer acetate for 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. It is
considered standard treatment for relapsing-remitting multiple
sclerosis, and is now approved in 55 countries worldwide. Teva’s
glatiramer acetate is designated as an orphan drug in Japan, and
currently is under development as an Unapproved New Drug by Teva
Pharmaceutical K.K., a subsidiary of Teva, at the request of the
Japanese Ministry of Health, Labor and Welfare.
Under the terms of the agreement, Teva will grant Takeda
commercialization rights in Japan, and Takeda will submit a New Drug
Application for registration of glatiramer acetate in Japan. The
financial details of the agreement are confidential.
Teva and Takeda will work under close cooperation so that both parties
can provide a new treatment option to patients with multiple sclerosis
in Japan as early as possible, where the current available therapies are
still limited.
About Glatiramer Acetate
Glatiramer acetate is indicated for the relapse prevention of multiple
sclerosis. The most common side effects of the drug are injection site
reactions (erythema, pain, mass, pruritus, and edema). It is now
approved in 55 countries worldwide, including the United States, Russia,
Canada, Mexico, Australia, Israel, and all European countries, and is
marketed under the brand name COPAXONE®. See additional
important information at:
http://copaxone.com/pdfs/PrescribingInformation.aspx
About Multiple Sclerosis
Multiple sclerosis is an autoimmune disease, the cardinal sign of which
is inflammatory demyelinating disorder of the central nervous system
characterized by demyelinating plaques in the brain and spinal cord.
Common symptoms include visual problems, ocular motor abnormality,
paresthesia, muscle weakness, spasticity, urinary dysfunction, and
cognitive impairment. The disease is categorized into three types: (1)
Primary progressive type, which takes a chronic progressive course from
the onset, (2) Relapsing-remitting type, which repeats relapse and
remission, (3) Secondary progressive type, which shifts to the
progressive course later even in a case with repeated relapse and
remission, more than 80% of the patients are categorized into the
relapsing-remitting type. The morbidity in patients is estimated to be
approximately 16,000 and its prevalence shows a trend of increasing in
Japan.
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.
About Takeda
Located in Osaka, Japan, Takeda is a research-based global company with
its main focus on pharmaceuticals. As the largest pharmaceutical company
in Japan and one of the global leaders of the industry, Takeda is
committed to strive towards better health for people worldwide through
leading innovation in medicine. Additional information about Takeda is
available through its corporate website, http://www.takeda.com.
Media Contacts:
Teva Pharma Japan Inc.
Corporate Communication Division
Tel: +81-52-459-2001
Takeda Pharmaceutical Company Limited
Corporate Communications Dept. (PR/IR)
Tel: +81-3-3278-2037
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, including
our ability to develop, manufacture, market and sell biopharmaceutical
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 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, 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.
Teva Pharmaceutical Industries Ltd.
IR:
Kevin C. Mannix
United
States
215-591-8912
or
Ran Meir
United States
215-591-3033
or
Tomer
Amitai
Israel
972 (3) 926-7656
or
PR:
Iris
Beck Codner
Israel
972 (3) 926-7687
or
Denise
Bradley
United States
215-591-8974