Xspray Pharma has obtained results from bioequivalence studies with HyNap-Dasa ANDA and decides to focus on its improved dasatinib product, Dasynoc™
Regulatory press release 2021-10-13
Xspray Pharma (publ) (Nasdaq Stockholm: XSPRAY) announces today that the Company has obtained results from the bioequivalence studies with the generic product candidate HyNap-Dasa ANDA C. The results show that the bioequivalence with the reference product Sprycel® was achieved in fed but not in fasting subjects due to the high variability of Sprycel®. The Company now chooses to focus entirely on the improved version, Dasynoc, which has achieved bioequivalence with a 30 percent lower dose than Sprycel®, and decides to end development of the generic version of dasatinib.
“We have been developing the generic and the improved versions of dasatinib, Dasynoc, in parallel, but now we choose to focus on Dasynoc since the market value is high not only during, but also after the end of the patent window. A shorter time in the patent window decreases the importance of the generic version in our product portfolio. An important consequence of this decision is to free up the capacity to accelerate the development of our current product candidates in the pipeline with longer patent window. The development of Dasynoc has been rapid and we can take advantage of the clinical improvements that amorphous formulations of protein kinase inhibitors (PKIs) provide for patients, doctors and payers", says Per Andersson, CEO of Xspray Pharma.
Submission for the market approval for Dasynoc in the USA is scheduled as planned for the fourth quarter this year, in accordance with the 505(b)(2) procedure.