BRIEF—Clinigen agrees deal for Viltepso managed access program with Nippon Shinyaku

UK-headquartered pharma services and products company Clinigen Group has signed an exclusive agreement with Japan’s Nippon Shinyaku to implement a managed access program (MAP) for Viltepso (viltolarsen) for patients with Duchenne muscular dystrophy (DMD) who are amenable to exon 53 skipping therapy.

Following finalization, the MAP will enable early access to the drug for eligible patients in countries where it is not commercially available. Viltepso is currently only approved in the USA and Japan.

Under the terms of the agreement, Clinigen will manage key elements of the program including regulatory oversight, logistics and access management.

Pete Belden, executive vice president, Services Division, Clinigen, said: “We are pleased to partner with Nippon Shinyaku to enable access to a valuable new treatment option for DMD, a rare and progressive disease for which there remains a clear unmet medical need.

“This agreement underlines Clinigen's strength in partnering with biotechnology companies to provide services that enable quicker and broader access to new innovative therapies.”