STOCKHOLM – March 17, 2020. Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) announces today that its production partner, Nerpharma, has received approval from Italian Medicines Agency (AIFA) for the full-scale production facility in Milan, Italy. The approval applies to clinical trial use of amorphous material based on the company’s HyNap technology. The company also announces that the Covid-19 pandemic may affect the start of the pivotal clinical bioequivalence studies.
“We are very pleased to receive this notification from AIFA that allows us to continue our development work. It represents an important milestone since it is a formal prerequisite for our upcoming pivotal HyNap-Dasa studies and thus for the subsequent ANDA-application that is currently being prepared,” says Per Andersson, CEO of Xspray Pharma. “Naturally, Xspray as many other companies sees an increased risk of delays depending on the impact of the virus outbreak. Due to the Covid-19 pandemic, we are awaiting to start our clinical trials until we are sure that they can be completed without any interruption. We follow the development week by week and this may result in a later submission of our ANDA application to the FDA than previously communicated."
The approval is a result of the successful completion of an AIFA review of Xspray Pharma’s production units installed at Nerpharma facility in Italy. This notification specifically applies to the production of amorphous material, affirming compliance with current GMP standards. The AIFA notification is a necessary part of Xspray Pharma's application for market approval in the US (ANDA application).
“This first in class commercial manufacturing facility for amorphous material will enable the manufacturing of all HyNap products in Xspray’s pipeline. Nerpharma has managed to build-up and install Xspray’s now approved manufacturing facility in a very aggressive timeline. Now we are looking forward to a rapid expansion and ramp-up in both production volumes and number of products”, says Angelo Colombo, CEO of Nerpharma S.R.L.
“We are impressed with our Italian colleagues at Nerpharma that keep the work going under the very tough conditions now prevailing”, continues Per Andersson.