News Release | TSD Japan, Inc.

February 02, 2009	Conclusion of Licence Agreement for HVJ Envelope TSD Japan, Inc. ("TSD") is delighted to announce that it has concluded its License Agreement with GenomIdea Inc. ("GenomIdea"), a subsidiary of AnGes MG, Inc. as of January 30th, 2009, in which TSD is granted with an exclusive license with sublicense rights for developing, manufacturing and distributing GEN0101(HVJ envelope) as an anti-prostate cancer agent in Japan. TSD will develop this agent as "TSD-0014." TSD has concluded Basic Agreement toward this License Agreement with GenomIdea in October 2008. (Please refer to the Press Release dated on October 9, 2008.) TSD-0014 has been known to activate cancer attacking T-cells and NK cells through its operation to dendritic cells that play important role for cancer related immunity. It is also known to effectively activate cancer related immunity through the mechanism of controlling regulatory T-cells which suppress cancer related immunity. The study has shown that TSD-0014 is effective for various types of cancer including hormone resistant prostate cancer in animals. The mechanism to mature dendritic cells is an important mode of action in the cancer immunity treatment where cytopathy T-cells (CTL) are induced. However, this mechanism alone has not been sufficient to produce efficacy. Therefore, having the mechanism to suppress the activation of regulatory T-cells and to enhance immune response to cancer, as TSD-0014 does, can considerably help to raise the expectation toward its efficacy. Furthermore, the past findings (although preliminary) of high safety level and very low toxicity level, excluding its effect to hemocyte, potentially raise expectations for TSD-0014 in its safety. The number of annual new patients of prostate cancer in Japan is 37,000 in 2005 and estimated to reach 53,000 in 2010 and 78,000 in 2020. It is expected that as a result of an increase in aging populations it will be the number two cause of death after lung cancer in men (Cancer Statistics in 2004). The number of death from prostate cancer in Japan was 9,265 in 2005 (National Cancer Center, Information on Cancer). As prostate cancer can be spread with increase of androgenic hormone, main drug therapy involves anti-andorgen or LH-RH analog. Due especially to lesser response to hormone drug after five or six years of treatment, a therapeutic drug with minimum adverse events and high efficacy is strongly desired in the clinical field. TSD will pursue the development of TSD-0014 for the treatment of hormone resistant prostate cancer. Because majority of hormone resistant prostate cancer patients are in their advanced ages, a type of treatment that helps to maintain QOL in the best manner and to prolong life-span is desired. TSD-0014 could be expected to play a significant role in the treatment of hormone resistant prostate cancer if the same level of efficacy and safety as in non-clinical studies were obtained in clinical trials. Moreover, a conservative estimate of its sales in the Japanese market alone could be over 40 billion yen in light of the expectations regarding patient number increase, potential drug price as a biological agent as well as the medical practice to widely use hormone formulations. Also, since the market for prostate cancer can be considered as ten times large as that for the Japanese market if taking into account of its possible future distribution to the global market, considerably large sales can be expected. The big size pharmaceutical companies having a therapeutic drug for prostate cancer in their pipelines are focusing on the development and in-licensing of such therapeutic drugs for hormone resistant prostate caner. Therefore, if expected efficacy is obtained, it will become one of our major pipelines for our partnering business. Following the conclusion of this License Agreement, TSD will pay GenomIdea milestones and running royalties. Since TSD concluded Basic Agreement with GenomIdea in October 2008, TSD has been successfully conducting non-clinical studies jointly with GenomIdea as scheduled. Considering the fact that TSD obtained the exclusive license with sub-license rights to the development, and manufacturing of investigational agent and commercial products, TSD will seek for the partner for developing and manufacturing based on risk-sharing and profit-sharing along with our business model. This agreement is considered an important step for us, which can open a door to our new future. As TSD has been focusing on the cancer areas, we will make every effort to tackle our development work so that TSD-0014 development could become successful as a ground-breaking product. For more information please contact: TSD Japan, Inc. (Masayuki Katae: Partnering) 1-15-2 nishinakajima, Yodogawa-ku, Osaka TEL 06-6309-5214 FAX 06-6309-5203 Press Release1(PDF) Press Release2(PDF) back

February 02, 2009

Conclusion of Licence Agreement for HVJ Envelope

TSD Japan, Inc. ("TSD") is delighted to announce that it has concluded its License Agreement with GenomIdea Inc. ("GenomIdea"), a subsidiary of AnGes MG, Inc. as of January 30th, 2009, in which TSD is granted with an exclusive license with sublicense rights for developing, manufacturing and distributing GEN0101(HVJ envelope) as an anti-prostate cancer agent in Japan. TSD will develop this agent as "TSD-0014."
TSD has concluded Basic Agreement toward this License Agreement with GenomIdea in October 2008. (Please refer to the Press Release dated on October 9, 2008.)

TSD-0014 has been known to activate cancer attacking T-cells and NK cells through its operation to dendritic cells that play important role for cancer related immunity. It is also known to effectively activate cancer related immunity through the mechanism of controlling regulatory T-cells which suppress cancer related immunity. The study has shown that TSD-0014 is effective for various types of cancer including hormone resistant prostate cancer in animals.

The mechanism to mature dendritic cells is an important mode of action in the cancer immunity treatment where cytopathy T-cells (CTL) are induced. However, this mechanism alone has not been sufficient to produce efficacy. Therefore, having the mechanism to suppress the activation of regulatory T-cells and to enhance immune response to cancer, as TSD-0014 does, can considerably help to raise the expectation toward its efficacy. Furthermore, the past findings (although preliminary) of high safety level and very low toxicity level, excluding its effect to hemocyte, potentially raise expectations for TSD-0014 in its safety.

The number of annual new patients of prostate cancer in Japan is 37,000 in 2005 and estimated to reach 53,000 in 2010 and 78,000 in 2020. It is expected that as a result of an increase in aging populations it will be the number two cause of death after lung cancer in men (Cancer Statistics in 2004). The number of death from prostate cancer in Japan was 9,265 in 2005 (National Cancer Center, Information on Cancer). As prostate cancer can be spread with increase of androgenic hormone, main drug therapy involves anti-andorgen or LH-RH analog. Due especially to lesser response to hormone drug after five or six years of treatment, a therapeutic drug with minimum adverse events and high efficacy is strongly desired in the clinical field.

TSD will pursue the development of TSD-0014 for the treatment of hormone resistant prostate cancer. Because majority of hormone resistant prostate cancer patients are in their advanced ages, a type of treatment that helps to maintain QOL in the best manner and to prolong life-span is desired. TSD-0014 could be expected to play a significant role in the treatment of hormone resistant prostate cancer if the same level of efficacy and safety as in non-clinical studies were obtained in clinical trials.

Moreover, a conservative estimate of its sales in the Japanese market alone could be over 40 billion yen in light of the expectations regarding patient number increase, potential drug price as a biological agent as well as the medical practice to widely use hormone formulations. Also, since the market for prostate cancer can be considered as ten times large as that for the Japanese market if taking into account of its possible future distribution to the global market, considerably large sales can be expected. The big size pharmaceutical companies having a therapeutic drug for prostate cancer in their pipelines are focusing on the development and in-licensing of such therapeutic drugs for hormone resistant prostate caner. Therefore, if expected efficacy is obtained, it will become one of our major pipelines for our partnering business.

Following the conclusion of this License Agreement, TSD will pay GenomIdea milestones and running royalties. Since TSD concluded Basic Agreement with GenomIdea in October 2008, TSD has been successfully conducting non-clinical studies jointly with GenomIdea as scheduled. Considering the fact that TSD obtained the exclusive license with sub-license rights to the development, and manufacturing of investigational agent and commercial products, TSD will seek for the partner for developing and manufacturing based on risk-sharing and profit-sharing along with our business model.

This agreement is considered an important step for us, which can open a door to our new future. As TSD has been focusing on the cancer areas, we will make every effort to tackle our development work so that TSD-0014 development could become successful as a ground-breaking product.

For more information please contact:
TSD Japan, Inc.
(Masayuki Katae: Partnering)
1-15-2 nishinakajima, Yodogawa-ku, Osaka
TEL 06-6309-5214 FAX 06-6309-5203

Press Release1(PDF)
Press Release2(PDF)

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