Update on recent developments regarding Dasynoc

Press release 2022-02-24

Xspray Pharma AB (publ), (Nasdaq Stockholm: XSPRAY) today announced an update on recent developments regarding Xspray Pharma’s first product, Dasynoc, currently under review by the United States Food & Drug Administration (“FDA”).

Bristol Myers Squibb (“BMS”) has filed a lawsuit in the United States District Court for the District of New Jersey against Xspray Pharma claiming patent infringement in relation to the filing of Xspray Pharma’s Dasynoc New Drug Application (“NDA”) with the FDA.

“Xspray Pharma has a process for making stable amorphous products that are not covered by BMS’s patents. While we cannot predict the outcome of any litigation, BMS’s lawsuit is entirely expected, and I am confident the court will ultimately rule in our favor and allow us to provide an improved product”, said Per Andersson, CEO Xspray Pharma.

The ongoing work with Dasynoc remains on track and these developments will not mean any change of strategic or operational direction for Xspray Pharma. It is also worth noting that the ongoing FDA approval process will proceed in parallel.

Xspray Pharma will not be providing any additional information or comments on this matter for the time being.

About Xspray Pharma

Xspray Pharma AB (publ) is a pharmaceutical company with several product candidates in clinical development. Xspray Pharma uses its innovative, patented RightSize™ technology to develop improved 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 72 in the end of 2021. The company’s leading product candidates, Dasynoc (former HyNap-Dasa), HyNap-Nilo, and HyNap-Sora, are stable amorphous versions of the three blockbuster cancer drugs Sprycel® (dasatinib), Tasigna® (nilotinib) and Nexavar® (sorafenib). HyNap-Dasa is being developed as an improved version of Sprycel. HyNap-Nilo is being developed as an improved version of Tasigna and has has received orphan drug status from the US FDA. HyNap-Sora is being developed as an improved version of Nexavar®.

The company has patented manufacturing technology, equipment, and the resulting products. The shares in Xspray Pharma are traded on Nasdaq Stockholm (Nasdaq Stockholm: XSPRAY).
www.xspraypharma.com