TesoRx Pharma and ASKA Pharmaceutical 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.
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.