Xspray Pharma AB has signed a manufacturing and Supply Agreement with NerPharMa to manufacture its Lead product candidate, HyNap-Dasa.
The agreement covers the clinical and world-wide commercial supply of HyNap-Dasa, and includes production of both Drug Substance and the finished product. HyNap-Dasa is one of three product candidates that Xspray currently has under development. The company's goal is to launch it in the US market in 2021.
Under the terms of the agreement, Xspray has contracted NerPharMa to manufacture drug substance and the finished product to supply material for clinical programs and for future world-wide commercial sales. Xspray is developing HyNap-Dasa both as a completely interchangeable variant of Sprycel to be registered in the United States by the Abbreviated New Drug Application ( ANDA ) route or as an improved product by the 505(b)(2) procedure.
"This contract is a significant step in our development of HyNap-Dasa," said Per Andersson, chief executive officer of Xspray Pharma. "We are pleased to have secured access to GMP production of drug substance and finished product for our continued clinical program as well as to GMP quantities of HyNap-Dasa for future commercial activities in an US FDA approved manufacturing facility."
