JERUSALEM & TOKYO--(BUSINESS WIRE)--Apr. 27, 2014--
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Takeda
Pharmaceutical Company Limited (Takeda) have signed an agreement
allowing Takeda to commercialize Teva’s innovative treatment for
Parkinson’s disease, rasagiline* (active ingredient) in Japan.
Developed by Teva, rasagiline tablets are approved in over 40 countries
for the treatment of Parkinson’s disease. Teva developed this product
and received its first approval in 2005 in Israel and Europe, and is
currently working towards the acquisition of marketing approval of this
product in Japan. Under the terms of the agreement, Takeda will develop
rasagiline tablets for the Japanese market and submit a New Drug
Application for registration of the product in Japan. The financial
details of the agreement are confidential.
Rasagiline is a monoamine oxidase B (MAO-B) inhibitor which is presumed
to act by increasing available synaptic dopamine in the brain which may
improve the motor symptoms characteristic of Parkinson’s disease.
Teva and Takeda announced an agreement in December 2013, to develop
glatiramer acetate* (active ingredient) for the treatment of multiple
sclerosis. Recognizing a high unmet need in the treatment options for
Parkinson’s disease in Japan, the two companies have now entered into a
further agreement in the CNS category.
“This agreement represents Teva’s continued commitment to introducing
our innovative medicines to patients in Japan,” stated Dr. Michael
Hayden, Teva’s President of Global R&D and Chief Scientific Officer.
“Rasagiline has an established safety and efficacy profile and is
currently approved for use in over 40 countries, and will be an
important product for Japan, where the number of available treatment
options for Parkinson’s disease remains limited.”
“It is estimated there are about 150,000-180,000** people diagnosed with
Parkinson's disease in Japan, many of whom are waiting for a new
treatment option,” said Nancy Joseph-Ridge, M.D., General Manager of
Takeda’s Pharmaceutical Development Division. “We will continue working
on the development in cooperation with Teva so that we can bring this
medicine to Japanese patients as quickly as possible.”
* While Rasagiline and Glatiramer Acetate are marketed globally as
Azilect® and Copaxone® respectively, their product
names have not yet been approved in Japan.
** Parkinson’s disease treatment guideline 2011, supervised by Japan
Society of Neurology
About Rasagiline
Rasagiline is indicated for the treatment of the signs and symptoms of
Parkinson's disease (PD) both as initial therapy alone and to be added
to levodopa later in the disease.
Side effects seen with rasagiline alone are flu syndrome, joint pain,
depression, and indigestion; and when taken with levodopa are
uncontrolled movements (dyskinesia), accidental injury, weight loss, low
blood pressure when standing, vomiting, anorexia, joint pain, abdominal
pain, nausea, constipation, dry mouth, rash, abnormal dreams, and fall.
See additional important information at www.azilect.com/Resources/pdf/PrescribingInformation.pdf
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 approximately 60 countries.
Teva's Specialty Medicines businesses focus on CNS, respiratory
oncology, pain, and women's health therapeutic areas as well as
biologics. Teva currently employs approximately 45,000 people around the
world and reached $20.3 billion in net revenues in 2013.
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
Safe Harbor Statement under the U.S. Private Securities Litigation
Reform Act of 1995:
This release contains forward-looking statements, which are based on
management’s current beliefs and expectations. 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 products, especially Copaxone®
(including competition from orally-administered alternatives, as well as
from potential generic versions); the possibility of material fines,
penalties and other sanctions and other adverse consequences arising out
of our ongoing FCPA investigations and related matters; our ability to
achieve expected results from the research and development efforts
invested in our pipeline of specialty and other products; our ability to
reduce operating expenses to the extent and during the timeframe
intended by our cost reduction program; our ability to successfully
pursue and consummate suitable acquisitions or licensing opportunities;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
our potential exposure to product liability claims that are not covered
by insurance; increased government scrutiny in both the U.S. and Europe
of our patent settlement agreements; our exposure to currency
fluctuations and restrictions as well as credit risks; the effectiveness
of our patents and other measures to protect the intellectual property
rights of our specialty medicines; the effects of reforms
in healthcare regulation and pharmaceutical pricing, reimbursement and
coverage; governmental investigations into sales and marketing
practices, particularly for our specialty pharmaceutical products;
uncertainties related to our recent management changes; the
effects of increased leverage and our resulting reliance on access to
the capital markets; any failure to recruit or retain executives or
other key personnel; 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
internal or third-party information technology systems that adversely
affect our complex manufacturing processes; significant disruptions of
our information technology systems or breaches of our data security; competition
for our generic products, both from other pharmaceutical companies and
as a result of increased governmental pricing pressures; competition for
our specialty pharmaceutical businesses from companies with greater
resources and capabilities; decreased opportunities to obtain U.S.
market exclusivity for significant new generic products; potential
liability for sales of generic products prior to a final resolution of
outstanding patent litigation; any failures to comply with complex
Medicare and Medicaid reporting and payment obligations; the impact of
continuing consolidation of our distributors and customers; significant
impairment charges relating to intangible assets and goodwill; the
potential for significant tax liabilities; the effect on our overall
effective tax rate of the termination or expiration of governmental
programs or tax benefits, or of a change in our business; variations in
patent laws that may adversely affect our ability to manufacture our
products in the most efficient manner; environmental risks; and other
factors that are discussed in our Annual Report on Form 20-F for the
year ended December 31, 2013 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 we assume 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.
Japan Media:
Teva Pharma Japan Inc.
Corporate Communication
Division, +81-52-459-2001
or
Takeda Pharmaceutical Company
Limited
Corporate Communications Dept. (PR/IR), +81-3-3278-2037
or
IR:
Kevin
C. Mannix, United States, 215-591-8912
Ran Meir, United States,
215-591-3033
Tomer Amitai, Israel, 972 (3) 926-7656
or
PR:
Iris
Beck Codner, Israel, 972 (3) 926-7687
Denise Bradley, United
States, 215-591-8974
or
Takeda:
Corporate Communications
Dept., Japan, 81(3)3278-2095