Xspray’s internal developmental projects presently consists of three product candidates which all are based on the RightSize-technology, as well as being stable amorphous versions of blockbuster cancer drugs Sprycel (dasatinib), Nexavar (sorafenib) and Tasigna (nilotinib). The mentioned drugs individually have yearly sales exceeding 1 billion USD.
Two of the Xspray product candidates, HyNap-Dasa and HyNap- Sora, have formally obtained Freedom to Operate (FTO) analyses as well as analyses of competition from well renowned patent bureaus in both Sweden and the United States. For the candidates HyNap-Nilo and HyNap-Dasa, Xspray has already shown clinical proof-of-concept (POC) and are in continued clinical development. HyNap-Sora, another candidate, is in formulation phase. All three product candidates have a well-defined road ahead of them in order to get approved as drugs by the FDA, something HyNap-Dasa has already achieved.
Xspray is developing HynAp-Dasa as both a completely interchangeable variant of Sprycel, which can be registered in the United States with the help of Abbreviated New Drug Application (Anda), or as an improved product of the 505(b)(2) procedure.