DURHAM, N.C., Feb. 09, 2021 (GLOBE NEWSWIRE) -- Aerami Therapeutics, Inc. (“Aerami” or the “Company”) a clinical stage biopharmaceutical company developing inhaled therapies to treat severe respiratory and chronic diseases today announces the signing of an exclusive license and development agreement with Hangzhou Chance Pharmaceuticals Co. Ltd. (“Chance”) 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 plc 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.
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.”
“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.
Clinical Needs
PAH is a devastating disease for which there is no cure. The disease causes blood vessels in the lungs to become narrowed, blocked or destroyed. The damage slows blood flow through the lungs, and blood pressure in the lung arteries rises. Over time, the heart must work harder to pump blood through the lungs, eventually causing the heart muscle to become weak and fail. Despite multiple products being available to treat the symptoms of PAH patients, it remains a fatal disease with substantial unmet needs.
The Inhaled Advantage
Although oral imatinib demonstrated statistically significant improvement in pulmonary hemodynamics and physical capacity in PAH patients in a Phase 3 trial, the indication was not pursued because of the substantial adverse events seen in that clinical trial. By delivering an inhaled imatinib directly to the site of the disease, Aerami believes that AER-901 can significantly reduce the dose necessary to achieve therapeutic benefit and avoid the significant adverse events seen with oral imatinib.
About Aerami Therapeutics – A clinical stage biopharmaceutical company developing inhaled therapies to treat severe respiratory and chronic diseases. More information can be found at www.aerami.com.
About Hangzhou Chance Pharmaceuticals Co. Ltd. – Chance Pharmaceuticals is a clinical-stage, research-based biotechnology company focusing on discovering, developing and commercializing transformative inhalation therapies for the world’s most debilitating diseases.
This press release contains “forward-looking statements” concerning the development and commercialization of Aerami’s product candidates, out-licensing arrangements, timing of clinical trials, the company’s business development efforts and its expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements, including the ability to obtain funding to support planned clinical activities. These statements are made as of the date of this press release. Actual results may vary. Aerami undertakes no obligation to update any forward-looking statements for any reason.