Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) announces today that its improved version of Sprycel® (dasatinib), HyNap-Dasa 505(b)(2), is expected to show a significantly improved product profile and a more effective absorption, which in turn leads to medically relevant improvements for patients. This version is based on the thoroughly tested “A” formulation and will be tested in a pivotal bioequivalent study during Q2.
The current formulation has undergone scale-up in the manufacturing process, stability testing, and has been tested in four clinical studies. External experienced pharmacokinetic experts have, with existing clinical data, calculated that with a 30 percent reduction in dose, the product should be bioequivalent to Sprycel®. Human bioequivalence studies confirms that the formulation:
“Our product is designed to improve the quality of life for patients with acute lymphocytic leukemia (ALL) and chronic myeloid leukemia (CML). I am convinced that our version, which is more soluble, bioavailable, gastric pH independent, and has a lower variability will lead to oncology physicians seeing improvements to both safety and efficacy. The application for market approval for our product will be submitted in accordance with the 505(b)(2) regulatory pathway”, says Per Andersson, CEO of Xspray Pharma.
HyNap-Dasa 505(b)(2) will be tested against Sprycel® at a 30% lower dose in a pivotal bioequivalence study. If results are positive, a 505(b)(2) NDA submission is expected during H2 2021.
In 2020 Sprycel® sold worldwide for USD 2.14 billion, of which USD 1.295 billion in the US. Xspray Pharma is working to obtain market approval for the improved version of dasatinib in the US, Europe, and all other major markets.