Xspray Pharma and Bristol Myers Squibb Reach Settlement on Dasynoc™ Patent Litigation, Paving Way for Early Market Launch

Regulatory press release 2023-09-11

Xspray Pharma today announced a resolution to its patent litigation with Bristol Myers Squibb (BMS) concerning its product, Dasynoc™. The settlement clears all pending claims, paving the way for Xspray to introduce Dasynoc™ to the market on September 1, 2024, pending final FDA approval. The launch may occur earlier under certain circumstances. The contested patents and their associated regulatory exclusivities expire on September 28, 2026.

The parties will proceed to file a dismissal with the United States District Court for the District of New Jersey, eliminating the need for any additional litigation on this matter. 
 
 “This settlement provides clarity on the launch date of our leading product, Dasynoc™, benefiting the market. It also allows Xspray to shift its focus towards ensuring a successful product debut in 2024. Funds that were previously earmarked for litigation can now be redirected towards advancing Xspray’s future products” commented Per Andersson, CEO Xspray Pharma.

For further information, please contact:

Kerstin Hasselgren
Chief Financial Officer
Xspray Pharma AB
Mob: +46 (0) 70 311 16 83
E-mail: kerstin.hasselgren@xspray.com

About Xspray Pharma

Xspray Pharma AB (publ) is a pharmaceutical company with numerous product candidates in clinical development, utilizing its innovative, patented HyNap-technology to create improved versions of marketed protein kinase inhibitors (PKI), the largest oncology segment often with high drug prices. The company's goal is to become a market leader of enhanced PKIs for cancer treatment. Xspray Pharma's primary drug candidate, Dasynoc (XS004-dasatinib), is currently undergoing FDA review. It is an amorphous form of dasatinib, demonstrating bioequivalence at a 30% lower dose because of better solubility profile. Its compatibility with proton pump inhibitors (PPIs), commonly co-prescribed to chronic myeloid leukemia patients, provides a significant advantage. Xspray Pharma is building a robust product portfolio, including XS003-nilotinib (an optimized version of Tasigna®) and XS008-axitinib (an optimized version of Inlyta®).

Xspray Pharma’s shares are traded at Nasdaq Stockholm (Nasdaq Stockholm: XSPRAY).
www.xspraypharma.com

This information is information that Xspray Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2023-09-11 16:44 CEST.

Attachments

Xspray Pharma and Bristol Myers Squibb Reach Settlement on Dasynoc™ Patent Litigation, Paving Way for Early Market Launch