First batch of HyNap-Dasa tablets manufactured on commercial scale according to GMP

Press release 2019-12-19

Xspray Pharma's CMO (Contract Manufacturing Organization) in the US, for the manufacturing of final tablets, has now produced the first batch of commercial-scale tablets according to GMP (Good Manufacturing Practice) standard. The manufactured batch is the first of three and is intended for regulatory stability studies which are scheduled to start early next year. According to the requirements of FDA, six months of data from these three batches is required before an ANDA application can be submitted.

”We can see that the HyNap-Dasa project is developing according to plan in all respects, and I am pleased with the results, especially since this is a completely new manufacturing process for the final tablets at our manufacturing partner in the US. Together with the production facilities for amorphous materials in Italy, we now have a complete supply chain in place. It is very satisfactory that we are continuously taking the steps required to prepare for an ANDA application, which is of great importance for our ongoing business development efforts," says Per Andersson, CEO of Xspray Pharma.

In parallel with the stability studies, the start of the pivotal clinical studies in healthy volunteers is being prepared. These are two bioequivalence studies in which Xspray's amorphous version of Sprycel is to be compared to the original drug. The studies have now received approval from the Ethical Committee in Canada where the studies will be conducted.

For more information, please contact:
Per Andersson, CEO, Xspray Pharma AB
Mobil: +46 (0) 706 88 23 48
E-post: per.andersson@xspray.com

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 47 in 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.

www.xspraypharma.com

Redeye AB is Xspray Pharma’s Certified Adviser

certifiedadviser@redeye.se

Telephone: +46 (0) 8 121 576 90

The information was submitted for publication, through the agency of the contact person set out above, at 10.00 a.m. CET on December 19, 2019.