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.