Xspray strengthens the value of the product portfolio with patent protection for tablet of dasatinib propylene glycol solvate

Regulatory press release 2020-08-18

Xspray Pharma AB (Nasdaq Stockholm: XSPRAY) announces today that the Company has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) regarding its patent application for tablets containing dasatinib propylene glycol solvate (dasatinib PG). When issued this patent will significantly strengthen Xspray's IP rights and means that any possible future generic products based on dasatinib PG, must consider Xspray's patents before entering the market.

Xspray's patent application relates to a tablet formulation that contains dasatinib PG. The patent is significant in Xspray's commercialization strategy where all future launches of generic products in tablet form based on dasatinib PG, must consider Xspray's patent. Receipt of the "Notice of Allowance" means that the USPTO will issue a U.S. patent to Xspray based on its pending application once Xspray pays the issue fee. Once paid, Xspray expects issuance of the patent in September. The patent will be Xspray's eighth patent for dasatinib in the U.S.

“It is very gratifying that our patent strategy results in receiving this Notice of Allowance. The U.S. patent will cover tablet products containing dasatinib PG. We make the assessment that any company planning to launch a product based on this form of dasatinib must consider Xspray's patent. We are currently aware of at least one such company. This increases the value of our product portfolio and strengthens our negotiating position, both towards the original company and the generic companies, when seeking commercialization opportunities for HyNap-Dasa,” comments Per Andersson, CEO of Xspray.

This patent concerning the tablet of dasatinib PG is the result from the work and know-how Xspray has gained from developing HyNap-Dasa, an amorphous form of dasatinib.

“We work continuously to secure the entire dasatinib market value as we do for all the products we develop. This has now resulted in a patent that potentially can change the generic landscape for dasatanib, and it adds substantial value to our two dasatinib product candidates in our product portfolio, HyNap-Dasa and HyNap-Dasa improved, that we are currently progressing”, continues Per Andersson.

Xspray’s HyNap-Dasa is a stable amorphous version of the anti-cancer drug Sprycel (dasatinib) that are currently being developed in two versions. First, a generic version for which the Company plans to file an ANDA, and thereafter an improved version which will follow the 505(b)(2) regulatory pathway. Bristol Meyer Squibb’s Sprycel® (dasatinib) is today approved for treatment of chronic myeloid leukmia (CML) and acute lymphoblastic leukemia (ALL) with reported global sales of USD 2.1 billion in 2019 of which U.S. sales represented USD 1.2 billion.