ASKA and TesoRx Announce Partnership to Develop Oral Testosterone for the Japanese Market

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Oral Testosterone Replacement Therapy Offers Promise in Japan

TesoRx Pharma LLC is a growth pharmaceutical company focused on rapidly developing and commercializing pharmaceutical products in rare and specialty markets with limited treatment options and high unmet need.

TesoRx Pharma LLC

The alliance with TesoRx is a significant transaction for ASKA in order to meet unmet medical needs in the field of urology, which has been a focus of the company since its inception.

TesoRx Pharma LLC and ASKA Pharmaceutical Co., Ltd. announced today they have entered into a partnership to develop and commercialize TesoRx’s novel oral testosterone product, THG-1001, in Japan. THG-1001 is an oral testosterone product candidate currently in preclinical development for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.

Under the terms of the collaboration, ASKA has made an upfront payment for an exclusive option to license the product for Japan in a deal containing a license fee, milestones and royalty payments on sales in the territory.

“The alliance with TesoRx is a significant transaction for ASKA in order to meet unmet medical needs in the field of urology, which has been a focus of the company since its inception. In preclinical studies, THG-1001 has demonstrated promise as a safe and effective oral testosterone drug that could provide a much needed treatment alternative for Japanese men suffering from the effects of low testosterone,” said Takashi Yamaguchi, President and Representative Director of ASKA.

“TesoRx is thrilled to enter this partnership with ASKA, a leader in hormone replacement in Japan with its intramuscular injection, Enarmon, representing 70 percent of the entire male TRT market. We look forward to working closely with ASKA and our team in Japan to bring THG-1001 to market as quickly as possible,” said TR Thirucote, Chairman and CEO of TesoRx.

Will Robberts, President and CFO of TesoRx, added: “This latest transaction with ASKA is consistent with TesoRx’s ongoing strategy of partnering with leading regional players to expedite THG-1001’s approval and commercialization in strategic countries around the world.”

Locust Walk served as a transaction advisor to TesoRx. ASKA was advised by Partners in Pharma LLC.

About THG-1001
THG-1001 is a novel oral TRT therapy containing Testosterone Undecanoate that is designed to help restore normal testosterone levels in hypogonadal men. In pre-clinical trials THG-1001 demonstrated safety and efficacy and the potential for once daily dosing. Preclinical studies have also shown that the product can be dosed in a fasted state without the need to consume fatty foods. TesoRx expects that THG-1001 will help fill an important unmet need in the treatment of hypogonadism where patients have limited or sub-optimal treatment options. The current testosterone market mainly consists of short-acting injectable products and topical products that carry an FDA "black box" warning related to inadvertent transfer of testosterone to others. The global TRT market has been estimated to be in excess of $2 billion annually.

About ASKA Pharmaceutical Co., Ltd.
ASKA Pharmaceutical Co., Ltd. is a leading Japanese pharmaceutical company focused on three fields; Internal medicine, the obstetrics and gynecology and urology. Since its foundation in 1920, it has built up a record of achievement as a pharmaceutical manufacturer and marketing distributor of specialty hormone preparations with technical capabilities that are top-class among Japanese companies. For further information, please visit the web site at http://www.aska-pharma.co.jp/english/index.html

About TesoRx Pharma LLC
TesoRx Pharma LLC is a growth pharmaceutical company focused on rapidly developing and commercializing pharmaceutical products in rare and specialty markets with limited treatment options and high unmet need. Its evolving pipeline includes assets in urology, oncology and rare diseases that have been formulated with TesoRx’s proprietary liposomal delivery technology. The company was founded in 2010 through a collaboration with Western University of Health Sciences that includes joint R&D efforts at the TesoRx Centre of Excellence in Pomona, California. More information at http://www.tesorx.com

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Hideki Kobayashi
@TesoRx
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