Bayhill Therapeutics Inc. has entered into an exclusive worldwide license agreement for the development and potential commercialization of BHT-3021 with Genentech, Inc. a wholly-owned member of the Roche Group. BHT-3021 is Bayhill’s DNA based antigen specific immunotherapy currently in a phase I/II clinical trial in patients with type 1 diabetes (T1D). Under the terms of the agreement, Genentech will make an upfront payment of $25M in cash and equity, with additional development, regulatory and sales milestone payments potentially exceeding $325M. Bayhill will also receive competitive escalating royalties on annual net sales. Bayhill will be responsible for completing the on-going phase I/II trial, while Genentech will be responsible for all future research, development, manufacturing and commercialization efforts. Genentech will reimburse Bayhill the remaining costs of the phase I/II trial and will fund all future expenses. Under the terms of the agreement, Bayhill retains rights to opt-in on future development as well as an option to co-promote in North America. Mark W. Schwartz, PhD, CEO and President of Bayhill Therapeutics, commented, “BHT-3021 represents a truly novel approach to treating type 1 diabetes. We believe this collaboration with Genentech reflects the significant potential of our approach to antigen specific tolerance, and will allow us to accelerate and expand the development of BHT-3021, while continuing to develop additional products from our BHT-DNA platform.” “The ultimate goal for treatment of autoimmune disease is antigen specific therapy,” commented Lawrence Steinman M.D., Founder, Director and Chairman of Bayhill’s Scientific Advisory Board. “Genentech has long been an innovator in immunology based therapies, making it a strong collaborator for BHT-3021. We look forward to working with the Genentech team on the development of BHT-3021.”
