Xspray – Successful submission of IND application to FDA
Press release 2019-10-04
STOCKHOLM – October 4, 2019. Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) announces that FDA has accepted the company’s submission of IND application for HyNap-Dasa.
Xspray Pharma announces a successful submission of its Investigational New Drug (IND) application to the Food and Drug Administration (FDA), with acceptance date September 30th 2019, in order to obtain permission to produce material for and perform clinical studies with the product candidate HyNap-Dasa.The Division of Hematology Products issued an IND Acknowledgment letter indicating that the application will be reviewed within 30 days.
For further information, please contact:
Per Andersson, CEO, Xspray Pharma AB
Mobile: +46 (0) 706 88 23 48
About Xspray Pharma
Xspray Pharma AB (publ) is a product development company with multiple product candidates in clinical development. Xspray uses its innovative, patented RightSize technology to develop improved and generic versions of marketed drugs, primarily protein kinase inhibitors (PKIs) for the treatment of cancer. The segment is the second largest in oncology, and drug prices are very high.
The company´s innovative technology allows Xspray Pharma to gain entry as the first competitor to today’s original drugs before the secondary patents expire. Xspray’s goal is to become the leader in the development of improved drugs or generic versions of PKIs already marketed for the treatment of cancer, which numbered 39 in 2018. The company’s leading product candidates, HyNap-Dasa, HyNap-Sora and HyNap-Nilo, are stable amorphous versions of the three blockbuster cancer drugs Sprycel® (dasatinib), Nexavar® (sorafenib) and Tasigna® (nilotinib), respectively. The launch of the first product candidate, HyNap-Dasa, is planned to take place in 2021. The substance patent for the original drug Sprycel® (dasatinib) expires at the end of 2020, and the secondary patents in 2026, which offers Xspray’s HyNap-Dasa a period of five years of semi-exclusivity before other competitors gain access to the market. The company has patented manufacturing technology, equipment and the resulting products. The shares in Xspray Pharma are traded on Nasdaq First North Growth Market Stockholm.
Redeye AB is Xspray Pharma’s Certified Adviser
Telephone: +46 (0) 8 121 576 90
This information was submitted for publication, through the agency of the contact person set out above, at 04.00 p.m. CET on October 4, 2019.