Aerami Therapeutics has announced the signing of an exclusive license and development agreement with Hangzhou Chance Pharmaceuticals to develop and commercialize Aerami’s drug device combination product candidate (AER-901) for the treatment of Pulmonary Arterial Hypertension (PAH) in mainland China, Hong Kong, Macau and Taiwan.
Under the agreement Chance will be responsible for the overall development and commercialization of AER-901for PAH in the territory. Aerami is progressing its own PAH clinical development program in the US and other territories for AER-901 pursuant to a worldwide license from Vectura Group to develop and commercialize imatinib for the treatment of PAH. Aerami’s program utilizes the commercially available FOX® device from Vectura to deliver imatinib, a tyrosine kinase inhibitor specific for PDGF-Rs, c-ΚΙΤ and BCR-ABL, directly to the lungs. Phase 1 clinical study results for AER-901 are targeted by the end of 2021, and Aerami targets initiation of a PAH pivotal trial early in 2022.
Aerami will receive an upfront license fee after signing as well as development milestone payments up until market authorization of AER-901 in China. Aerami will supply the product to Chance at an agreed transfer price and receive a high single digit royalty on net sales and sales milestone payments. Chance will be responsible for conducting and financing local clinical trials required to obtain market authorization in China.
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“We are delighted to be working with Chance on this important product in China and see this as further validation of our drug device combination approach to this terrible disease. We believe that AER-901 has the potential to improve the quality of PAH patients’ lives based on the significant efficacy demonstrated in a proof-of-concept Phase 3 trial completed with oral imatinib,” Steve Thornton, Chief Executive Officer of Aerami, said.
“External collaboration is an integral part of our corporate strategy to establish Chance as a leader in inhalation therapies. Chance is committed to develop innovative and game changing therapies for patients in China and the rest of the world. This collaboration expands our pipeline to PAH, a disease with a very poor prognosis despite tremendous progress achieved in the last decade. We believe the inhalation delivery can avoid the side effects of oral imatinib and are very pleased to be able to develop this innovative therapy for PAH patients in the Greater China region,” Donghao Chen, Founder and CEO of Hangzhou Chance Pharmaceuticals said.