Hangzhou Chance Pharmaceuticals (“Chance”), a clinical-stage biotechnology company focusing on discovering, developing and commercializing transformative inhalation therapies for the world’s most debilitating diseases, and Aerami Therapeutics, Inc. (“Aerami” ), a clinical stage biopharmaceutical company developing inhalation therapies to treat severe respiratory and chronic diseases, announced today that they have signed an exclusive license and development agreement to develop and commercialize Aerami’s drug device combination product candidate (“AER-901”) for the treatment of Pulmonary Arterial Hypertension (“PAH”) in Greater China region (Mainland, Hong Kong, Macau and Taiwan).
Under the terms of the license and collaboration agreement, Chance will be responsible for the overall development and commercialization of AER-901 for PAH in the licensed territory. Aerami will undertake its own PAH clinical development program in the US and other territories for AER-901, pursuant to a worldwide license from Vectura Group plc [LSE: VEC] 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 targeting PDGF-Rs, c-ΚΙΤ and BCR-ABL, directly to the lungs. Aerami targets Phase 1 clinical study results for AER-901 by the end of 2021 and initiation of a PAH pivotal trial in early 2022.
Aerami will receive an upfront license fee and is eligible to receive development and commercial milestone payments. Aerami will supply the product to Chance at an agreed transfer price and receive a high single digit royalty on net sales. Chance will be responsible for conducting and financing local clinical trials required to obtain market authorization in China.
“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,” commented Donghao Chen, Founder and CEO of Hangzhou Chance Pharmaceuticals.
Steve Thornton, Chief Executive Officer of Aerami, commented, “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.”
