Xspray receives notification of manufacturing approval and provides update on clinical studies

Regulatory press release 2020-03-17

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 ofamorphous 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.


For more information, please contact:
Per Andersson, CEO, Xspray Pharma AB
Phone: +46 (0) 706 88 23 48

About Xspray Pharma
Xspray Pharma AB (publ) is a product development company with multiple product candidates in clinical development. Xspray uses its innovative, patented RightSize technology to develop improved and generic versions of marketed drugs, primarily protein kinase inhibitors (PKIs) for the treatment of cancer. The segment is the second largest in oncology, and drug prices are very high.

The company´s innovative technology allows Xspray Pharma to gain entry as the first competitor to today’s original drugs before the secondary patents expire. Xspray’s goal is to become the leader in the development of improved drugs or generic versions of PKIs already marketed for the treatment of cancer, which numbered to 54 in December 2019. The company’s leading product candidates, HyNap-Dasa, HyNap-Sora and HyNap-Nilo, are stable amorphous versions of the three blockbuster cancer drugs Sprycel® (dasatinib), Nexavar® (sorafenib) and Tasigna® (nilotinib), respectively. The launch of the first product candidate, HyNap-Dasa, is planned to take place in 2021. The substance patent for the original drug Sprycel® (dasatinib) expires at the end of 2020, and the secondary patents in 2026, which offers Xspray’s HyNap-Dasa a period of five years of semi-exclusivity before other competitors gain access to the market.

The company has patented manufacturing technology, equipment and the resulting products. The shares in Xspray Pharma are traded on Nasdaq First North Growth Market Stockholm.



Redeye AB is Xspray Pharma’s Certified Adviser


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This is information that Xspray Pharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 5.20 p.m. CET on March 17, 2020.