Santhera and Takeda Establish Collaboration to Develop
and Market Idebenone (SNT-MC17) in Neuromuscular
Disease
Idebenone (SNT-MC17) Will Be the First Treatment for
Friedreich's Ataxia
LIESTAL, Switzerland and OSAKA, Japan, August 03, 2005
/PRNewswire/ -- Santhera Pharmaceuticals AG
("Santhera") of Switzerland and Takeda Pharmaceutical
Company Limited ("Takeda") of Japan announced today
that they will collaborate to develop and
commercialize Idebenone (SNT-MC17), a small molecule
drug for the treatment of Friedreich's Ataxia
("FRDA"). The clinical development for FRDA is about
to enter a Phase III clinical study in Europe and will
enter a Phase III study in the US shortly thereafter.
The product has orphan drug designation in the US and
Europe.
Under the terms of the collaboration, Santhera will
conduct all clinical development for regulatory
approval in Europe and in the US. Takeda will support
the development work and will obtain an exclusive
license to market Idebenone (SNT-MC17) in the European
Union and Switzerland. Santhera will in return receive
an upfront payment of Euro 5 million, development
milestones and royalties from Takeda. Full financial
terms were not disclosed. Santhera will supply drug
product to Takeda for Europe. In the US, Santhera
plans to market Idebenone (SNT-MC17) on its own.
"We are pleased to be working with Santhera, a leader
in neuromuscular drug research and development," said
Yasuchika Hasegawa, President and Chief Operating
Officer of Takeda. "Together with Santhera, we look
forward to the successful development and
commercialization of a medicine that will, for the
first time, allow for the treatment of Friedreich's
Ataxia, a life-threatening neuromuscular disease for
which currently no pharmaceutical therapies exist."
"I am pleased to announce Santhera's first development
and marketing partnership in this area with a company
of the stature of Takeda," said Klaus Schollmeier,
Ph.D., Chief Executive Officer of Santhera. "Santhera
has already built significant R&D expertise in
neuromuscular diseases. With the help of Takeda's
European organization, we are now leveraging that
strength to bring our lead product, a decisive therapy
breakthrough, to patients. We are very excited to work
with Takeda, who is the ideal partner for us to bring
the product to the European market."
FRDA is a hereditary and disabling neuromuscular
disorder that severely impacts quality of life and
reduces patients' life expectancies substantially.
Although FRDA is primarily a neurological disease,
cardiac symptoms are well recognized to be a
life-threatening complication of the disease. The most
common cardiac manifestation is hypertrophic
cardiomyopathy which ultimately causes death in the
majority of FRDA patients.
It has been shown that Idebenone (SNT-MC17), a small
molecule oral therapy, can improve mitochondrial
function and/or reduce oxidative stress in muscle
cells, heart cells and neurons. By protecting heart
muscle cells form the oxidative stress that is mainly
responsible for the deterioration of the heart muscle
in FRDA, Idebenone (SNT-MC17) could offer the first
therapy option which can prolong the lives of
patients.
About Takeda
Takeda, located in Osaka, Japan, 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 striving toward better health for
individuals and progress in medicine by developing
superior pharmaceutical products.
Takeda's four core therapeutic areas in R&D are:
- Franchise I: Life style-related diseases;
- Franchise II: Oncology & Urologic diseases;
- Franchise III: Central nervous system diseases;
- Franchise IV: Gastroenterology diseases LCM
For further information, please visit
http://www.takeda.com/index-e.html
About Santhera
Santhera Pharmaceuticals AG is a Swiss
biopharmaceutical company founded in 2004 through a
merger between Germany-based Graffinity
Pharmaceuticals AG and Swiss-based MyoContract AG.
Santhera is focused on the discovery, development and
marketing of small molecule pharmaceutical products
for the treatment of neuromuscular diseases and has a
fully integrated platform for the discovery and
development of drug candidates. The company,
headquartered in Switzerland, has operations in
Liestal, Switzerland (near Basel) and in Heidelberg,
Germany, as well as a business development office in
Boston, MA, USA. Santhera's investors comprise Merlin
Biosciences Limited, Oxford Bioscience Partners, NGN
Capital, 3i Group plc, Carnegie Asset Management, The
Novartis Venture Fund, Varuma AG, GIMV, Clariden Bank,
The Dow Chemical Company, Heidelberg Innovation,
TechnoStart, tbg, the Swiss Foundation for Research on
Muscle Diseases, and private investors.
For further information, please visit
http://www.santhera.com.
CONTACT: For further information, please contact:
SantheraPharmaceuticals: Klaus Schollmeier, Ph.D.,
+41-(0)-61-906-89-52,; Citigate Dewe Rogerson: Mark
Swallow,+44-(0)-207-638-9571; David Dible,
+44-(0)7967566919,; Takeda: Seizo Masuda,
+81-6-6204-2060,; Toshiyuki Ikeuchi, +81-6-6204-2050,
klaus.schollmeier@santhera.com
david.dible@citigatedr.co.uk Masuda_Seizo@takeda.co.jp
Ikeuchi_Toshiyuki@takeda.co.jp
http://www.medadnews.com/News/Index.cfm?articleid=261569
Quelle: [internaf-news] Idebenone News