ASKA and TesoRx Announce TSX-011 (Oral Testosterone) Proceeding to Human Studies Following Successful PK Study Results

Oral Testosterone Replacement Therapy Advances in the USA and Japan

SAN FRANCISCO, CA. & TOKYO, JAPAN, April 27, 2017 -- TesoRx Pharma LLC and ASKA Pharmaceutical Co., Ltd. announced that, based on the successful results of recently completed preclinical PK study, they will be proceeding together in the preparation and execution of the upcoming Phase 1/2a trial of TesoRx’s novel oral testosterone product, TSX-011.  The parties anticipate that this study will be conducted in the US, and will include Japanese patients to expedite development in both regions.  Under the terms of the collaboration, ASKA made an undisclosed payment to TesoRx for achieving this milestone.

“We are extremely pleased with the non-clinical PK study results of our novel oral testosterone formulation, TSX-011. We look forward to initiating the Phase 1/2a study of TSX-011 in patients later this year,” said TR Thirucote, Chairman and CEO of TesoRx.  

“ASKA is thrilled to continue this important collaboration with TesoRx.  The upcoming clinical study will include a significant number of Japanese patients which we expect to speed up the development of TSX-011 in Japan,” said Takashi Yamaguchi, President of ASKA.  

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

 

NOTES TO EDITORS

About TSX-011

TSX-011 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 TSX-011 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 TSX-011 will help fill an important unmet need in treating hypogonadism where patients have limited or sub-optimal treatment options. The current testosterone market mainly consists of injectable and nasal formulations 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, 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 focused on rapidly developing and commercializing pharmaceutical products in rare and specialty markets with limited treatment options and high unmet need. Its growing pipeline includes assets in urology, oncology and rare diseases that have been formulated with TesoRx’s proprietary proliposomal 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 www.tesorx.com

IR contact at ASKA

Name: Hideki Kobayashi, Corporate Planning Department

Email: kouhou@aska-pharma.co.jp

IR contact at TesoRx:

Name: Will Robberts:

Email: info@tesorx.com