Xspray Pharma enters Manufacturing Agreement with NerPharMa for its lead product candidate; HyNap-Dasa
Press release 2017-12-21
Xspray Pharma AB, a specialty pharmaceutical company, today announced that it has signed a Manufacturing and Supply Agreement with NerPharMa S.r.l., a pharmaceutical manufacturing company in Milan, Italy, 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 HyNap-Dasa 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. NerPharMa is a pharmaceutical manufacturing company and a subsidiary of Nerviano Medical Sciences S.r.l., Milan, Italy.
NerPharMa’s GMP manufacturing facility is approved by both the Italian Medicines Agency (AIFA), the national authority responsible for drug regulation in Italy, and the U.S. Food and Drug Administration (FDA).
“This contract is a significant step in our development of HyNap-Dasa,” said Per Andersson, CEO 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.”
“We are pleased to be working with Xspray Pharma to manufacture and provide finished product for their investigational and commercial needs,” said Angelo Colombo, CEO of NerPharMa.