With a patent feud settled and its approval application back at the FDA’s desk, Sweden’s Xspray Pharma believes it's on track to launch its first commercial product late this summer.
Xspray Pharma’s XS003 Achieves Superior Bioavailability Milestone
With Xspray Pharma and Eversana’s cancer med hitting a regulatory setback, a launch in the second half of 2023 now looks unlikely. That’s good news for Bristol Myers Squibb, which has secured a few more competition-free months for its aging leukemia blockbuster Sprycel.
STOCKHOLM, Feb. 23, 2023 /PRNewswire/ -- Xspray Pharma AB, (NASDAQ Stockholm: XSPRAY) has signed an agreement with EVERSANA® to support the U.S. launch and commercialization of the company's first innovative cancer therapy Dasynoc for the treatment of chronic myeloid leukemia (CML) and acute lymphatic leukemia (ALL). While maintaining financial and strategic control, Xspray Pharma will grant EVERSANA exclusive commercialization access to support its Dasynoc launch, aimed at the second half of 2023. Dasynoc, pending FDA-approval and legal conditions, will be a new and differentiated treatment option for CML and ALL patients, entering the $3.5 billion commercial market for Tyrosine Kinase Inhibitors in the United States – a market that has grown by nearly 5% in the last year alone.
Bristol-Myers Squibb Co. filed a lawsuit alleging XSpray Pharma AB’s proposed branded generic version of Sprycel tablets infringes two patents for the blockbuster leukemia drug, which generated more revenue last year than all but five of Bristol-Myers’ products.