Hangzhou, China, February 9 2021 (GLOBE Newswire) — 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-901for 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.”
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 in the lungs and raises blood pressure in the lung arteries. 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 available to treat the symptoms of PAH, 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, Chance and Aerami believe that AER-901 can significantly reduce the dose necessary to achieve therapeutic benefits and avoid the significant adverse events seen with oral imatinib.
About Aerami Therapeutics
A clinical stage biopharmaceutical company developing inhalation therapies to treat severe respiratory and chronic diseases. For more information, please visit www.aerami.com
About Hangzhou Chance Pharmaceuticals Co. Ltd.
Chance Pharmaceuticals is a clinical-stage biotechnology company focusing on discovering, developing and commercializing transformative inhalation therapies for the world’s most debilitating diseases. For more information, please visit http://www.chancepharmaceuticals.com/
Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” concerning the development and commercialization of product candidates, in-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. Chance undertakes no obligation to update any forward-looking statements for any reason.
Hangzhou Chance Pharmaceuticals
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