OSAKA, Japan – November 30, 2007 -- TSD Japan Inc. (Osaka, Japan; CEO
Osamu Shiho) is pleased to announce that TSD Japan has entered into a
license agreement with Alizyme Therapeutics Limited (Cambridge, United
Kingdom; CEO Tim McCarthy) to co-develop COLAL-PRED® for the treatment of
ulcerative colitis in Japan.
With the signing of this agreement, TSD
Japan has obtained the rights to license and co-develop COLAL-PRED® in
Japan up through the end of Phase II clinical trials. The agreement
provides that Alizyme and TSD Japan share the development costs and that
in the event of the licensing-out of COLAL-PRED® to a pharmaceutical
company in Japan, both companies share in the received milestone and
royalty payments.
COLAL-PRED®
COLAL-PRED® is a prednisolone derivative developed utilizing Alizyme’s proprietary DDS (Drug Delivery System) technology called COLAL®. This unique DDS technology enables this potent anti-inflammatory drug to travel through the gastrointestinal tract unchanged until it reaches the colon where certain enterobacteria then digest the specially designed coating on the drug pellets and release it for a localized effect. This targeted delivery of this potent anti-inflammatory agent is expected to reduce the frequency and severity of adverse events that can be caused by systemically administered steroids. Alizyme is currently conducting a Phase-III study in Europe and has recently entered into an agreement with the US –based company Prometheus for development of COLAL-PRED® in North America. Alizyme and TSD plan to start a joint Phase-I study in Japan in 2008.
TSD Japan, Inc.
TSD Japan is a bio-venture company established in July 2005. Its
business focuses include partnering activities that involve in-licensing
pharmaceutical drug candidates from companies both at home and abroad for
potential development in Japan and, after completion of some basic
clinical studies, out-licensing these candidates for further development
and eventual marketing. The company also provides a wide range of
integrated CRO services.
For further information on TSD Japan, please
refer to:
http://www.tsd-japan.co.jp
Alizyme Therapeutics Limited
Alizyme is a specialty pharmaceutical development company based in
Cambridge, UK. It has a portfolio of products that include those for
gastrointestinal disorders, obesity and mucositis. In the area of
anti-obesity products, a license agreement has been signed between Alizyme
and a major domestic pharmaceutical company.
For further information
on Alizyme, please refer to: http://www.alizyme.com/alizyme/
Ulcerative Colitis
Ulcerative colitis is a type of inflammatory bowel disorder in which mucosal erosions and abscesses form in the colon mucosa. The cause is unknown. The clinical presentations of ulcerative colitis are diarrhea, rectal bleeding and frequent abdominal pain. The inflammation characteristically starts in the rectum but can then proceed upwards and can eventually involve the entire colon. Patients with ulcerative colitis usually have alternating periods of acute illness and remission during the course of the disease, but the condition is usually chronic. This disease has been on the official MHLW list of intractable diseases since 1975. The accumulative number of those who have received medical care for this condition was approximately 85,000 in 2005, but the number is steadily increasing with 5,000 new cases being reported each year.
Mr. Tim McCarthy, Chief Executive Officer Alizyme commented:
"We are delighted to enter into this strategic agreement with TSD in Japan, which is exemplified by our co-development of COLAL PRED® as the first step in our partnership. We have maintained a strong relationship with Dr Shiho, the CEO and founder of TSD, following his time with Takeda Pharmaceutical Company Limited and are excited by the many new opportunities this partnership will offer in the overall corporate development of Alizyme. We believe Dr Shiho and his experienced team at TSD are uniquely positioned to maximize the development and commercialization of COLAL PRED® for Japan, and offer Alizyme further access to the Japanese market."
Dr. Osamu Shiho, Chief Executive Officer TSD Japan commented:
“COLAL-PRED®, developed by Alizyme, is a unique compound to be co-developed by TSD Japan’s pharmaceutical partnering business, and I believe that its significant potential as a pharmaceutical agent will greatly assist us in realizing our corporate objective of developing and commercializing innovative products for the Japanese market. I would like to see our collaborative relationship broaden in the future, both in providing Alizyme access to new products for their portfolio and providing TSD access to other promising compounds from the Alizyme portfolio.”
For further information, please contact:
Osamu Shiho, MD, Chief Executive Officer
Masayuki Katae, Corporate
Officer and Head of Licensing
TSD Japan, Inc.
Tel:
+81-6-6309-5200
Fax: +81-6-6309-5203
