(Alliance News) - Clinigen Group PLC on Monday said it entered an exclusive agreement with Kyoto, Japan-based pharmaceutical company Nippon Shinyaku Co Ltd to provide early access to Viltepso in countries where it is not available yet.
The Staffordshire-based pharmaceuticals and services provider said it signed the agreement with Shinyaku to implement an managed access program for Viltepso for patients with Duchenne muscular dystrophy who are amenable to exon 53 skipping therapy.
Viltepso is currently only approved in the US and Japan and the program is supposed to enable early access to for eligible patients in countries where it is not commercially available yet.
Clinigen will manage key elements of the program including regulatory oversight, logistics and access management.
"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," said Pete Belden, executive vice president of the Services division.
Shares in Clinigen were up 0.3% at 588.50 pence each on Monday morning in London.
By Abby Amoakuh; abbyamoakuh@alliancenews.com
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