Xspray Pharma (publ) (Nasdaq Stockholm: XSPRAY) announces today that all healthy volunteers in the bioequivalence studies with an adjusted tablet formulation of the generic HyNap-Dasa ANDA have been dosed. The studies have been conducted in two groups of healthy volunteers under fasting and non-fasting conditions. The purpose of the studies is to achieve bioequivalence for HyNap-Dasa to the reference product Sprycel® (dasatinib). The preliminary results are expected in April.
“The development work for these adjusted formulations began immediately after we received the final results from the bioequivalence studies conducted during the second quarter 2020. This first formulation can be viewed as slightly riskier than the latter, but if bioequivalence is reached a little earlier, we believe it is worth the risk. In case bioequivalence is not achieved with the first formulation, we will be able to start studies with the other formulation in the second quarter,” says Per Andersson, CEO of Xspray Pharma. “Multiple studies are common in the development of generics and I note that our studies are fairly quick to carry out. We are now in the third month of the patent window's expected timeframe of 45 - 60 months, where Sprycel® today sells for over USD 100 million every month in the U.S. The high value of the product candidate is partly time dependent which motivates this study”.
Xspray Pharma's leading product candidate HyNap-Dasa is being developed both as a generic and an improved version of BMS's Sprycel® (dasatinib) for the treatment of chronic myeloid leukemia (CML) and acute lymphocytic leukemia (ALL). The primary patent for Sprycel® expired in December 2020 and the secondary patent in 2026, giving HyNap-Dasa a patent window of several years before other competitors gain access to the market. In 2020, the global market for Sprycel® amounted to approximately USD 2.1 billion, of which the US market accounted for approximately
USD 1.3 billion.