Astellas Pharma has entered into an exclusive license agreement, worth up to $625 million, with Frequency Therapeutics, a biopharmaceutical company focused on small-molecule drugs, to develop and commercialize Frequency Therapeutics’ regenerative therapeutic candidate, FX-322, for treating hearing loss.

Under the agreement, Astellas will be responsible for the development and commercialization of FX-322 outside of the US and Frequency will be responsible for US development and commercialization. The companies will be jointly responsible for conducting global clinical studies and coordinating commercial launch activities. Frequency will receive an upfront payment of $80 million and may also receive up to an additional $545 million based on development and commercial milestones, as well as royalties on any future product sales in the licensed territory.

FX-322 is a proprietary combination of small-molecule drugs designed to restore hearing function by activating inner ear progenitor cells already present in the body to induce hair-cell regeneration. FX-322 is indicated for the treatment of sensorineural hearing loss. As of July 2019, there are no approved therapeutic options for sensorineural hearing loss, according to the companies. Sensorineural hearing loss is the result of damage and/or loss of sensory hair cells in the inner ear.

The World Health Organization estimates that there are currently more than 800 million adults with hearing loss globally. According to the US National Institutes of Health, approximately 90 percent of those with hearing loss are affected by sensorineural hearing loss.

Source : Astellas