SAN FRANCISCO and TOKYO, Dec. 1, 2017 /PRNewswire/ -- TesoRx Pharma LLC and ASKA Pharmaceutical Co., Ltd. announced today they have expanded their existing collaboration to develop and commercialize TesoRx's novel oral testosterone product, TSX-011, in Japan to include South East Asia. In addition, the parties have agreed to include exclusive rights to TesoRx's oral testosterone for the treatment of constitutional delay in growth and puberty ("CDGP") for Japan and Southeast Asia. ASKA has simultaneously made an equity investment in TesoRx.
TSX-011 is a clinical-stage oral testosterone product candidate currently in development for testosterone replacement therapy ("TRT") in adult males to treat conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
TesoRx's novel testosterone formulation for CDGP has demonstrated appropriate testosterone levels in Phase 2 clinical studies in men and will be confirmed in clinical trials for adolescent boys in 2018. In June, 2016, The US Food and Drug Administration (FDA) granted Orphan Drug Designation to this formulation for the treatment of CDGP in adolescent boys (age 14-17 years).
Under the terms of the collaboration, ASKA has agreed to a license fee, development and commercialization milestone payments and ongoing royalties on the commercialization of TSX-011 in South East Asia.
"The expanding relationship with TesoRx is allowing ASKA to grow its urology business in key South East Asia territories, such as Korea, Singapore, Thailand, Taiwan, Vietnam and the Philippines. In addition, our equity investment shows our commitment to leveraging TesoRx's drug delivery platform into other promising therapeutic areas," said Takashi Yamaguchi, President and Representative Director of ASKA.
"We are excited to expand our relationship with ASKA, a leader in hormone therapies in Japan. We are collaborating closely with ASKA in our current Phase 1/2 clinical studies, which include Japanese patients," said TR Thirucote, Chairman and CEO of TesoRx.
Will Robberts, President and CFO of TesoRx, added, "We continue to pursue a strategy of early-stage partnering deals with leading international pharmaceutical companies to target major markets outside the USA. These relationships are also likely to yield collaborations utilizing our platform technology to enhance existing products and spawn exciting new therapies."
Locust Walk served as transaction advisor to TesoRx. ASKA was advised by Partners in Pharma LLC.
TSX-011 is a novel oral testosterone replacement therapy containing testosterone undecanoate designed to help restore testosterone levels in hypogonadal men. Men with hypogonadism currently have suboptimal treatment options dominated by gels carrying FDA black box warnings for inadvertent transference and inconvenient injectable and nasal formulations. In pre-clinical trials, TSX-011 demonstrated safety and efficacy and the potential for once daily dosing without the need to consume fatty foods. The global TRT market has been estimated to be in excess of $2 billion annually.
About TesoRx's Oral Drug Delivery Technology
TesoRx's innovative oral drug delivery technology allows for drugs to be incorporated into a solid pro-liposomal formulation that is contained in an enteric coated capsule. The capsule bypasses gastric degradation in the stomach and solves the first pass metabolism challenge of some drugs. Once the capsule releases in the intestines and the formulation hydrates, the liposomal complexes are absorbed via the lymphatic system. By bypassing the liver, the platform has solved the challenge of hepatic metabolism and allows for excellent oral bio-availability of the drug.
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 evolving pipeline includes assets in urology, oncology and rare diseases that have been formulated with TesoRx's proprietary proliposomal drug delivery system. 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. For further information visit www.tesorx.com.
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 visit http://www.aska-pharma.co.jp/english/index.html
SOURCE TesoRx Pharma LLC