Stability studies initiated with Xspray’s HyNap-Dasa tablets

Regulatory press release 2020-02-11

STOCKHOLM – February 11, 2020. Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) announces that the stability studies with the company’s commercially manufactured HyNap-Dasa tablets began today, February 11. The readout of the study results after six months will be a part of the company’s ANDA application (Abbreviated New Drug Application) for market approval in the US for the HyNap-Dasa product. The application is planned to be submitted to the FDA in the third quarter of 2020. This means that the development of the company's first product candidate HyNap-Dasa, an amorphous version of Sprycel® (dasatinib), is proceeding according to plan.

On February 11, the stability studies of the final HyNap-Dasa tablets, manufactured on a commercial scale according to GMP standard (Good Manufacturing Practice) were initiated. The tablets will be evaluated after six months in stability studies according to regulatory requirements. 

”The results of the studies now underway are an important part of our upcoming ANDA-application for Hy-Nap Dasa to the FDA. Furthermore, we expect the official approval of our production facility in Milan from the Italian pharmaceutical authority, AIFA, within the next few months. In parallel, the pivotal clinical bioequivalence studies in healthy volunteers will be initiated during the spring. All in all, this will form the basis for our ANDA-application, which we intend to submit during the third quarter this year” says Per Andersson, CEO of Xspray Pharma.

The tablets for the stability studies are manufactured by Xspray’s Contract Manufacturing Organization (CMO) in the US. The first batch of tablets on a commercial scale was produced according to GMP standard in December 2019.
 

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

www.xspraypharma.com

Redeye AB is Xspray Pharma’s Certified Adviser

certifiedadviser@redeye.se

+46 (0) 8 121 576 90

 

This information is inside 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 6:40 p.m. CET on February 11, 2020.