Xspray, NerPharMa Sign Manufacturing and Supply Agreement
Xspray Pharma, a Solna, Sweden-headquartered specialty pharmaceutical company, has signed a manufacturing and supply agreement with NerPharMa, a Milan, Italy-headquartered contract development and manufacturing organization, to manufacture Xspray’s lead product candidate, HyNap-Dasa.
The agreement covers the clinical and worldwide 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 agreement, Xspray has contracted NerPharMa to manufacture the drug substance and the finished product to supply material for clinical programs and for future worldwide commercial sales. Xspray is developing HyNap-Dasa both as a completely interchangeable variant of Sprycel (dasatinib)— owned by Bristol-Myers Squibb and Otsuka— to be registered in the US by the abbreviated new drug application route or as an improved product by the 505(b)(2) procedure—a pathway created by the Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to a section of the Federal Food, Drug, and Cosmetic Act. NerPharMa is a pharmaceutical manufacturing company and a subsidiary of Nerviano Medical Sciences, a pharmaceutical research & development facility in Milan, Italy.
NerPharMa’s GMP manufacturing facility is approved by both the Italian Medicines Agency, the national authority responsible for drug regulation in Italy, and the US Food and Drug Administration.