Stem Cell Sciences and Celogos Sign a Licensing Deal on Autogenous Myoblast Transplantation For Urinary Incontinence Therapy

Stem Cell Sciences and Celogos Sign a Licensing Deal on Autogenous Myoblast Transplantation For Urinary Incontinence Therapy

PARIS, France and KOBE, Japan | Feb 15, 2007 |
Celogos, the biotechnology company focused on the development and production of innovative cell-based technologies in the field of cellular medicine, and Stem Cell Sciences KK (SCSKK), the bio-venture company specialized in regenerative medicines, have reached an agreement on the licensing of technologies for myoblast cell implantation for the treatment of stress urinary incontinence.

Under this license, Celogos has granted SCSKK exclusive rights to commercialize in Japan therapeutic products developed under Celogos' patent and know-how related to myoblast implantation.

The alliance is based on Celogos' fundamental technology platform known as Rational Cell Design (RCD) that is applicable to the development, optimization, production and transplantation of novel cells. Celogos is developing a therapy for urinary incontinence and is currently in Phase I/II clinical trials in France. RCD technologies have enabled Celogos to establish a complete process for myoblast implantation, from removal of muscular tissue biopsy, cell-isolation and cultivation, to their transplantation into the urethral sphincter of urinary incontinence patients. In this process line, cell-separation and cell-cultivation are conducted under tight quality control in a GMP compliant Cell Processing Center (CPC).

SCSKK is currently working actively to develop its own technologies and to introduce further technologies from third parties, and has already obtained an exclusive license related to human Multipotent Adipose-Derived Stem (hMADS) cells for therapeutic use and research use from University of Nice/CNRS in 2005 and 2006, respectively. This new technology from Celogos will provide SCSKK with a more clinically advanced product to expand and diversify the range and development stages of the SCSKK cell therapy pipeline. SCSKK plans to promote further research and development of these remarkable products to facilitate commencement of early clinical trials.

Mr. Kenzo Nakajima, President and CEO of SCSKK, said "We are very pleased to be able to complement our therapeutic pipeline with these clinically advanced Celogos technologies. These technologies will facilitate the production of autologous cell transplantation treatments for stress urinary incontinence for women, and urinary incontinence for men after prostatectomy. With clinical trials now ongoing in France and the highly refined nature of the technological process we can have confidence in the anticipated safety and efficacy profiles of this therapeutic product. We further expect that the necessary authorizations required from the Ministry of Health, Labor and Welfare in Japan, including authorization for commencement of clinical trials, should not require a complex procedure. We plan to launch a clinical trial in the first quarter of 2008."

Dr. André Ulmann, Executive Director and President of Celogos, commented: "We are delighted to have established this collaboration with Stem Cell Sciences KK, a pioneer in the development of stem cell-based therapies. This agreement is a further validation of the unique potential of our RCD technology platform. Preliminary results on RCD1, the Company's product for the treatment of stress urinary incontinence, are very promising and we anticipate receiving regulatory approval for its commercialization before 2010. This agreement also represents our first deal with a company in Japan, the world's third largest pharmaceutical market."

- Ends-

Notes to Editors

About Stem Cell Sciences KK (SCS KK):

A biotechnology company started on 2002 as a joint venture company between Stem Cell Sciences Limited in Australia and Sosei Co., Ltd. in Japan, and is currently focusing on a realization of cell therapy business. The Company is currently developing stem cell technologies for cell therapies utilizing various intellectual properties obtained from its affiliated company, Stem Cell Sciences plc in the UK. Such technology development includes collaborative researches with RIKEN Centre for Development Biology (CDB), Research Institute for Cell Engineering at National Institute of Advanced Industrial Science and Technology (Amagasaki, Hyogo) and participation in the research project titled "Collaboration of Regional Entities for the Advancement of Technological Excellence" supported by the Ministry of Education, Culture, Sports, Science and Technology in Japan. For further information about SCS KK, please visit our web-site, www.scskk.com <http://www.scskk.com/> or contact Stem Cell Sciences KK on TEL:+1-81-78-306-0381 or E-mail to: This email address is being protected from spambots. You need JavaScript enabled to view it. This email address is being protected from spambots. You need JavaScript enabled to view it.> .

About Celogos:

Celogos specializes in the development of cell-based therapies, with a particular focus on muscle regeneration. Celogos' proprietary technology platform called Rational Cell Design (RCD) allows for the isolation of muscle precursor cells from biopsies of a patient's muscle. These precursor cells are grown up using a fully patented culture process, frozen and then reinjected into the patient at the affected site. The cells then develop into mature muscle cells, repairing the damaged tissue.

Regulatory approval of RCD1 for stress urinary incontinence is anticipated to be received before 2010. The Company is also developing cell therapy products indicated for the treatment of fecal incontinence (RCD2), a rare genetic ocular myopathy (RCD3) and diseases of the cardiac muscle.

Headquartered in Paris, France, Celogos was founded in 2001. The company was acquired in 2005 by HRA Pharma, a French pharmaceutical company that has brought clinical development and business expertise in the pharmaceutical field to Celogos' strong scientific know-how in muscle regeneration. For further information about Celogos, please visit our website, www.celogos.fr <http://www.celogos.fr/>

About Urinary incontinence:

Urinary incontinence - or the inability to control the passage of urine - affects around 1 in every 20 people, and the worldwide market for treatments for the condition is expected to increase to over USD 7 billion by 2006, mostly driven by the ageing global population. It is estimated that several million people are affected by urinary incontinence in Japan.

There are two main types of urinary incontinence. Stress urinary incontinence is characterized by a leakage of urine which occurs without bladder constriction on increment of abdominal pressure from coughing, sneezing, laughing or exercise. The second type, impeding or urge urinary incontinence involves a leakage of urine accompanied by a sudden impeding micturition desire.

Targets for cell therapies include patients suffering from stress urinary incontinence, linked to insufficiency of internal urethral sphincter muscle caused by radiation therapy, surgery or post-pregnancy.

SOURCE: Celogos

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