(Alliance News) - Pharmaceutical services company Clinigen Group PLC on Monday said it has secured Orphan Drug Designation in the US for Aldesleukin in the treatment of amyotrophic lateral sclerosis, or ALS.
The Orphan Drug Designation was granted by the US Food & Drug Administration's Office of Orphan Products Development.
ALS is a neurodegenerative disease which affects motor neurons leading to progressive muscle weakness, paralysis and ultimately death within a median time of 2 to 4 years from disease onset.
An Orphan Drug Designation in the US recognizes the potential therapeutic role of Aldesleukin in treating ALS, and the designation could provide a number of benefits for Clinigen should it obtain a marketing approval for this indication. These benefits include seven years of marketing exclusivity within the US upon launch, along with tax credits for clinical development costs and fee waivers.
Burton, England-based Clinigen said it is supplying the Aldesleukin being used in the ongoing Mirocals study evaluating its clinical potential within ALS, and it is investigating the optimal pathway to generating the data required to support an application for a marketing authorisation.
Shares in Clinigen were up 1.5% at 792.50 pence each in London on Monday morning.
By Tapan Panchal; tapanpanchal@alliancenews.com
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