News Release | TSD Japan, Inc.

October 09, 2008	Conclusion of Basic Agreement for Future License Agreement for HVJ Envelope Vector TSD Japan, Inc. ("TSD") is delighted to announce that it has concluded Basic Agreement withGenomIdea Inc. ("GenomIdea"), a subsidiary of Anges MG, Inc., toward License Agreementwhere TSD is granted with exclusive license to develop, manufacture and distribute the HVJenvelope vector as an anti-prostate canter agent in Japan. Non-clinical studies suggested that HVJ-E activated T-cells and NK cells to eradicate tumorsthrough dendritic cell-mediated mechanism for antigen presentation in antitumor immunity. Itis also known that HJV-E effectively activates antitumor immune response by inhibitingregulatory T cell-mediated immunosuppression. Further studies have shown that HVJ-E iseffective for various tumors including hormone refractory prostate cancer in animal model. Themechanism to mature dendritic cells is an important mode of action in the immunotherapywhere cytotoxic T-lymphocyte (CTL) is induced. However, some reports imply that themechanism might not be completely sufficient for acceptable efficacy. Therefore, HVJ-E couldlead to the sharp efficacy due to the dual mechanism of (i)inhibition of regulatory Tcell-mediated immunosuppression and (ii)maturation of dendritic cell for antigen presentation.On the other hand, preliminary toxicological studies showed the preferable safety profile ofHVJ-E, although accompanied with limited observations possibly caused by the original effectsof HVJ to hemocytes, potentially resulting in the expectations in its safety. The number of annual patients with prostate cancer in Japan is about 37,000 in 2005 andestimated to reach 53,000 in 2010 and 78,000 in 2020. It is speculated that prostate cancer willbe the second one following lung cancer in number of male patients in Japan as a result ofexpanding elderly population (Cancer Statistics in 2004). The fatality of patients with prostatecancer was 9,265 in 2005 in Japan (National Cancer Center, Cancer Information service). Asprostate cancer grow depending on androgenic hormones, major drug therapy involvesanti-androgen or LH-RH analogs. Due especially to lesser response to hormone therapy afterfive or six years of treatment, a therapeutic drug with minimum adverse events and highefficacy is strongly desired in the clinical field. TSD will pursue the development of HVJ-E for the treatment of hormone refractory prostatecancer. Because majority of patients with hormone refractory prostate cancer are in theiradvanced ages, a type of treatment will be selected from the viewpoint of the drug profile forhigh level QOL and prolongation of survival rather than for strong efficacy associated withfrequent adverse events. HVJ-E could be expected to play a significant role in the treatment ofhormone refractory prostate cancer if the efficacy and safety profile demonstrated in animalmodels could be also obtained in clinical trials. Moreover, a conservative sales forecast could be over 40 billion yen just in the Japanese marketbased on the assumption including the factors of increased patient number, potential drug priceas a biological agent as well as the medical practice to widely use hormone therapy. Also, theglobal market for prostate cancer can be considered as ten times larger than the Japanesemarket, possibly resulting in considerable large sales with global development. The majorpharmaceutical companies with the portfolios including therapeutic drug for prostate cancerare focusing on the development and acquisition of such therapeutic drugs for hormonerefractory prostate caner. Therefore, if favorable outcomes are obtained, HVJ-E will become oneof our major pipelines for our partnering business. Upon the conclusion of this Basic Agreement, TSD will pay to GenomIdea consideration for thegrant of exclusive rights for negotiation up to the timing of license agreement. Following theconclusion, we will pay milestones and royalties subsequent to the launch. TSD will conduct thenon-clinical studies jointly with GenomIdea. This agreement is considered an important step for us to open a door to the new horizon. As TSDhas been focusing on the cancer areas, we will make every effort for successful development ofHVJ-E as a breakthrough product. For more information please contact: TSD Japan, Inc. (Masayuki Katae: Partnering) 1-15-2 Nishinakajima, Yodogawa-ku, Osaka TEL +81-6-6309-5214 FAX +81-6-6309-5203 081009Press Release1 081009Press Release2 back

October 09, 2008

Conclusion of Basic Agreement for Future License Agreement for HVJ Envelope Vector

TSD Japan, Inc. ("TSD") is delighted to announce that it has concluded Basic Agreement withGenomIdea Inc. ("GenomIdea"), a subsidiary of Anges MG, Inc., toward License Agreementwhere TSD is granted with exclusive license to develop, manufacture and distribute the HVJenvelope vector as an anti-prostate canter agent in Japan.

Non-clinical studies suggested that HVJ-E activated T-cells and NK cells to eradicate tumorsthrough dendritic cell-mediated mechanism for antigen presentation in antitumor immunity. Itis also known that HJV-E effectively activates antitumor immune response by inhibitingregulatory T cell-mediated immunosuppression. Further studies have shown that HVJ-E iseffective for various tumors including hormone refractory prostate cancer in animal model. Themechanism to mature dendritic cells is an important mode of action in the immunotherapywhere cytotoxic T-lymphocyte (CTL) is induced. However, some reports imply that themechanism might not be completely sufficient for acceptable efficacy. Therefore, HVJ-E couldlead to the sharp efficacy due to the dual mechanism of (i)inhibition of regulatory Tcell-mediated immunosuppression and (ii)maturation of dendritic cell for antigen presentation.On the other hand, preliminary toxicological studies showed the preferable safety profile ofHVJ-E, although accompanied with limited observations possibly caused by the original effectsof HVJ to hemocytes, potentially resulting in the expectations in its safety.

The number of annual patients with prostate cancer in Japan is about 37,000 in 2005 andestimated to reach 53,000 in 2010 and 78,000 in 2020. It is speculated that prostate cancer willbe the second one following lung cancer in number of male patients in Japan as a result ofexpanding elderly population (Cancer Statistics in 2004). The fatality of patients with prostatecancer was 9,265 in 2005 in Japan (National Cancer Center, Cancer Information service). Asprostate cancer grow depending on androgenic hormones, major drug therapy involvesanti-androgen or LH-RH analogs. Due especially to lesser response to hormone therapy afterfive or six years of treatment, a therapeutic drug with minimum adverse events and highefficacy is strongly desired in the clinical field.

TSD will pursue the development of HVJ-E for the treatment of hormone refractory prostatecancer. Because majority of patients with hormone refractory prostate cancer are in theiradvanced ages, a type of treatment will be selected from the viewpoint of the drug profile forhigh level QOL and prolongation of survival rather than for strong efficacy associated withfrequent adverse events. HVJ-E could be expected to play a significant role in the treatment ofhormone refractory prostate cancer if the efficacy and safety profile demonstrated in animalmodels could be also obtained in clinical trials.

Moreover, a conservative sales forecast could be over 40 billion yen just in the Japanese marketbased on the assumption including the factors of increased patient number, potential drug priceas a biological agent as well as the medical practice to widely use hormone therapy. Also, theglobal market for prostate cancer can be considered as ten times larger than the Japanesemarket, possibly resulting in considerable large sales with global development. The majorpharmaceutical companies with the portfolios including therapeutic drug for prostate cancerare focusing on the development and acquisition of such therapeutic drugs for hormonerefractory prostate caner. Therefore, if favorable outcomes are obtained, HVJ-E will become oneof our major pipelines for our partnering business.

Upon the conclusion of this Basic Agreement, TSD will pay to GenomIdea consideration for thegrant of exclusive rights for negotiation up to the timing of license agreement. Following theconclusion, we will pay milestones and royalties subsequent to the launch. TSD will conduct thenon-clinical studies jointly with GenomIdea.

This agreement is considered an important step for us to open a door to the new horizon. As TSDhas been focusing on the cancer areas, we will make every effort for successful development ofHVJ-E as a breakthrough product.

For more information please contact:

TSD Japan, Inc.
(Masayuki Katae: Partnering)
1-15-2 Nishinakajima, Yodogawa-ku, Osaka
TEL +81-6-6309-5214 FAX +81-6-6309-5203

081009Press Release1
081009Press Release2

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