News Releases
Co-development and Commercialization Agreement
For a Cellular-based Drug Using Human Mesenchymal Stem Cells
For the Treatment of Graft-versus-Host Disease
JCR Pharmaceuticals Co., Ltd.
Mochida Pharmaceutical Co., Ltd.
(Tokyo, December 21, 2007) - JCR Pharmaceuticals Co., Ltd.(JCR) (Shin Ashida, Chairman) and Mochida Pharmaceutical Co., Ltd. (Mochida) (Naoyuki Mochida, President) have entered into an agreement regarding JR-031 (development code), the human mesenchymal stem cells (hMSCs) which JCR is developing under a license from Osiris Therapeutics, Inc. (USA). JCR and Mochida will co-develop and commercialize JR-031 for Japan as the first therapeutic cellular-based drug in Japan to be applied for the treatment of graft-versus-host disease (GvHD), which is a serious side effect arising from hematopoietic stem cell transplantation. Subject to this agreement, JCR will receive lump sum and milestone payments from Mochida.
Following the technology transfer from Osiris in August 2003, JCR has been developing JR-031. In May of this year, JCR obtained a confirmation from the (Japanese) Ministry of Health, Labour and Welfare (MHLW) that JR-031 meets the “Guidelines Regarding the Quality and Safety Assurance of Human-derived Cells and Cell-processed Drugs”. JCR anticipates submitting the clinical trial notice (for GvHD) with the MHLW this month.
In U.S.A., Canada, Australia and Europe, Osiris is conducting similar clinical trials evaluating hMSCs (Prochymal) for GvHD. Prochymal is currently in Phase III pivotal trials for both acute GvHD and steroid refractory acute GvHD.
MSCs are present in the bone marrow and are multipotential, or have the ability to differentiate in to various tissue lineages such as bone, fat and muscle. Along with ES cells, MSCs are found promising for their use in the regenerative medicine. MSCs can engraft without provoking immune response, but MSCs have a unique property to inhibit immune response. JR-031 utilizes such immunosuppressive effect to treat GvHD.
Furthermore, typically, in the regenerative medicine, MSCs taken from the patients are prepared (formulated) and such autologous MSCs are returned to those patients. In the case of JR-031, it is prepared from the bone marrow aspirate of eligible healthy donors and can be used in patients in general. JCR and Mochida will aim for the commercialization of JR-031 as a “therapeutic drug” rather than a “therapy”.
【Summary of JCR Pharmaceuticals Co., Ltd.】
(1) Founded September 13, 1975
(2) Headquarters in 3-19 Kasuga-cho, Ashiya, Hyogo (Japan)
(3) Representative Shin Ashida, Chairman, President and CEO
(4) Capital 7,504,860,000 yen (as at March 31, 2007)
(5) Number of employees 209 (as at March 31, 2007)
【Summary of Mochida Pharmaceutical Co., Ltd. 】
(1) Founded April 16, 1913
(2) Headquarters in 1-7 Yotsuya, Shinjuku-ku, Tokyo (Japan)
(3) Representative Naoyuki Mochida, President
(4) Capital 7,229,930,000 yen (as at March 31, 2007)
(5) Number of employees 1,367 (as at March 31, 2007)
【Summary of Osiris Therapeutics, Inc.】
(1) Company name Osiris Therapeutics, Inc.
(2) Founded December 1992
(3) Headquarters in Columbia, Maryland, U.S.A.
(4) Representative C. Randal Mills, Ph.D., President and CEO
(5) Capital $220,000,000
(6) Number of employees 109 (as at September 30, 2007)
(7) ＵＲＬ http://www.osiristx.com/