Additional product patent in the United States for HyNap-Dasa

Regulatory press release 2018-12-04

STOCKHOLM, SWEDEN – December 4, 2018. Xspray Pharma AB (Nasdaq First North: XSPRAY) (“Xspray” or the “Company”) announces that the United States Patent and Trademark Office (USPTO) today has granted a new patent in the United States to Xspray. The new patent, US 10,143,683, covers the pharmaceutical composition of Xspray’s lead product candidate, HyNap-Dasa. This is Xspray’s third product patent in the US which is Xspray’s main market. The new patent will expireJanuary 11, 2033.

 “This new patent approval in our most important market further confirms our innovative development work. Together with the previously communicated formal clinical bioequivalence for the company´s lead product candidate, HyNap-Dasa, this patent will be instrumental in our forthcoming negotiations with potential partners,” says Per Andersson, CEO of Xspray.

Xspray strives to obtain patents both for composition and methodology, and this new patent claims an amorphous solid dispersion (pharmaceutical composition) of dasatinib.

“The new patent for HyNap-Dasa has the broadest scope of all our composition patents in the US and makes it significantly more difficult for other companies to launch a dasatinib product based on amorphous solid dispersion formulation in the US market during the lifetime of this patent, i.e. up until 2033”, says Per Andersson, CEO of Xspray.

For further information, please contact:

Per Andersson, CEO, Xspray Pharma AB                                                                      

Mobile: +46 (0) 706 88 23 48                                                                                           

Email: per.andersson@xspray.com

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 08.00 a.m. CET on 4 December 2018.

About Xspray Pharma

Xspray Pharma AB (publ) is a product development company with several product candidates in clinical development. Xspray Pharma uses its innovative patented RightSize technology to develop improved generic versions of marketed drugs, primarily protein kinase inhibitors (PKIs) for the treatment of cancer. The segment is the second-largest in the field of oncology and drug prices are high. Through its innovative technology, Xspray Pharma’s strategy is, through outlicensing to an appropriate pharmaceutical company, to enter the market as first competitor to the original drugs before the exclusivity from secondary patents expires. Three PKIs have been identified as the initial product candidates (HyNap-Dasa, HyNap-Sora and HyNap-Nilo). Xspray Pharma's goal is to have up to seven products ready for launch in the US market, where the first product to launch in 2021 will be HyNap-Dasa. The substance patents for Sprycel®(dasatinib)*, expire in 2020 and the secondary patents expire in 2026, which can give Xspray Pharma’s HyNap-Dasa a five-year period of special position before other competitors get 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 Stockholm. The company's Certified Adviser is Redeye AB, www.redeye.se.

*Sprycel® is a registered trademark of Bristol-Myers Squibb

www.xspraypharma.com