On August 2, 2018 Xspray Pharma reported that the first clinical trial material from NerPharMa S.r.l., Xspray’s strategic pharmaceutical manufacturing partner in Milan, has been delivered to the HyNap-Dasa clinical trial, the results of which are expected in Q3 2018 (Press release, Xspray, AUG 2, 2018, View Source [SID1234650103]). HyNap-Dasa is one of three product candidates that Xspray currently has in development. The company’s goal is to launch HyNap-Dasa on the US market in 2021.
Xspray has contracted NerPharMa to produce materials for Xspray’s clinical program and finished products for future commercial sale. The material delivered to the HyNap-Dasa study is the first resulting from this collaboration.
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Xspray is developing HyNap-Dasa both as a fully equivalent version of Sprycel to be registered in the US under an Abbreviated New Drug Application (ANDA), or as an improved product under the 505(b)(2) regulatory procedure. NerPharMa is a pharmaceutical contract manufacturer and subsidiary of Nerviano Medical Sciences S.r.l. of Milan, Italy.
NerPharMa’s GMP manufacturing facility has been approved by the Italian Medicines Agency (AIFA), Italy’s national authority responsible for drug regulation, and the US Food and Drug Administration (FDA).
The clinical HyNap-Dasa trial is a pilot study, testing two formulations in healthy volunteers. Study results are expected in the third quarter and will be the base of the planned pivotal study, scheduled to start in 2019.
"Technology transfer in the pharmaceutical industry is complex, but our partnership with Nerpharma over the past half-year has gone very well, and we were able to deliver clinical trial material according to plan," commented Per Andersson, CEO of Xspray Pharma.
"We’ve now proved that we can deliver GMP materials in an FDA-approved manufacturing facility, both clinical. This is critical, partly for our ongoing clinical program, but first and foremost, for our future commercial sales in the US."
"We’re delighted that the transfer of Xspray’s technology has gone well, and that we now have functional equipment at NerPharMa. I’m convinced that we’ll see more widespread uptake of Xspray’s very useful technology soon," responded Angelo Colombo, CEO of NerPharMa.