Tokyo, January 31, 2017 – Astellas Pharma Inc. (“Astellas”; Head Office: Tokyo, President and CEO: Yoshihiko Hatanaka) today announced that it executed a license agreement with respect to an exclusive worldwide license for an AU-935 program with Auration Biotech, Inc. (“Auration”, Head Office: San Mateo, California, President and CEO: Benjamin F. McGraw, III, PharmD).

Astellas and Auration executed an evaluation agreement with an option for Astellas to enter into the license agreement with Auration for AU-935 in October 2015. Astellas concluded to exercise the option as the efficacy of AU-935 was confirmed with pre-clinical studies for chronic tympanic membrane perforation conducted by Astellas under the agreement.

Tympanic membrane perforation can result from middle ear infections, pressure equalization, tube implantation or injury. Most perforation heal spontaneously within a few months but in some cases the perforation becomes chronic. In these cases, the only currently available treatment is an invasive surgical procedure.

AU-935 is a program, based on a discovery from Stanford University, that includes the active substance heparin-binding epidermal growth factor-like growth factor (HB-EGF). HB-EGF is a member of the EGF family and has been shown to play a critical role in the process of tympanic membrane regeneration. AU-935 is being developed as a simple ear topical application that would be an alternative to the surgical procedure.

Going forward Astellas will, at its cost and expense, develop and commercialize AU-935.  Astellas will make an up-front payment at the time of the execution of the agreement and milestone payments upon the achievement of certain development milestones.  Moreover, Astellas will make royalty payments at certain rate for net sales of the product.

For the purpose of enhancing the capability to create new drugs, Astellas is looking for challenges in new therapeutic areas and novel technology platforms as well as new drug discovery opportunities that address unmet medical needs through collaboration with external partners. The agreement with Auration is one of these initiatives, and Astellas continues strengthening these efforts.

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About Auration

Auration Biotech, Inc., based in San Mateo, California, is a privately held biotechnology company dedicated to the development of novel therapeutics that restore or maintain hearing.