Date: 2014-01-13
Type of information: Termination of an agreement
Compound: drisapersen (previously GSK2402968/PRO051) and other DMD programmes
Company: Prosensa (The Netherlands) GSK (UK)
Therapeutic area: Genetic diseases - Neuromuscular diseases - Rare diseases
Type agreement: licensing
rights
Action mechanism: antisense oligonucleotide. Drisapersen is an antisense oligonucleotide, which induces exon skipping of exon 51.
Disease: Duchenne muscular dystrophy
Details: * On January 13, 2014, Prosensa and GSK have announced that Prosensa has regained all rights from GSK to drisapersen and will retain rights to all other programmes for the treatment of Duchenne muscular dystrophy (DMD). In 2009 GSK obtained an exclusive worldwide license from Prosensa to develop and commercialize drisapersen.This transfer of rights represents the termination of this collaboration agreement between GSK and Prosensa. Prosensa will now have the full, unencumbered rights to continue the development of drisapersen as well as each of its DMD programmes. The parties have agreed that Prosensa is well suited to continue the development of all of the DMD programmes. Prosensa and GSK have also agreed to make certain data from the drisapersen studies available in due course to the scientific community for the purpose of furthering the general understanding of DMD.
Drisapersen is currently in-late stage development for DMD. It has orphan drug status in the EU, US, Japan and Australia. In June 2013, drisapersen was granted Breakthrough Therapy designation by the FDA. The overall drisapersen clinical programme comprises three double-blind, placebo-controlled studies (DMD114117, DMD114876 and DMD114044) and two long term open-label extension studies (DMD114673 and DMD114349). First phase 3 results have been announced in September 2013.
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