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news.GlaxoSmithKline (GSK) and Amicus Therapeutics have entered into a definite agreement to jointly develop and commercialise Amigal (migalastat HCl), currently in Phase 3, for the treatment of fabry disease.
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Migalastat HCl is an investigational treatment for fabry disease and has the potential to be the first in a new class of oral, small molecule medicines called pharmacological chaperones, GSK said.
As per the agreement, GSK will get an exclusive worldwide license to develop, manufacture and commercialise Migalastat HCl.
GSK and Amicus also plan to advance clinical studies exploring the co-administration of Migalastat HCl with enzyme replacement therapy (ERT) for the treatment of Fabry disease.
Under the contract, GSK and Amicus will jointly fund development costs in accordance with an agreed upon development plan.
The total cash upfront to Amicus from GSK for the license payment and equity investment is approximately $60m.
GSK Rare Diseases global head Marc Dunoyer said that the company’s focus now is to continue to advance Amigal for fabry disease and it is their hope to deliver a first-in-class, oral medicine to the thousands of people worldwide living with this devastating rare disease.
A Phase 3 study (Study 011) has already been commenced in the second quarter of 2009 and treatment of the first patient began in the fourth quarter of 2009. The ongoing study is a 6-month, randomised, double-blind trial comparing migalastat HCl to placebo in 60 subjects in approximately 40 investigational sites worldwide.