GSK and Amicus Therapeutics sign exclusive agreement

To develop and commercialise Amigal for Fabry disease

UK pharmaceutical manufacturer GlaxoSmithKline (GSK) has licensed a treatment for Fabry disease from Amicus Therapeutics.

GSK said it has agreed to pay Amicus an upfront payment of US$30m to license Amigal (migalastat HCl) and pay up to US$170m if the drug, currently in Phase III trials, achieves various development and commercialisation milestones.

The two companies will jointly fund development costs and GSK has also agreed to invest US$31m in Amicus by taking a 19.9% stake in the company and will pay tiered double-digit royalties on global sales of Amigal, if it is approved.

GSK will receive exclusive worldwide rights to develop and commercialise the drug.

GSK and Amicus also intend to advance clinical studies exploring the co-administration of migalastat HCl with enzyme replacement therapy (ERT) for the treatment of Fabry disease.

John Crowley, chairman and chief executive of Amicus Therapeutics, said the deal provides a ‘strong validation of the potential for Amigal to become an important new treatment for people with Fabry disease’.

It is estimated that Fabry disease affects approximately 5,000 to 10,000 people worldwide.

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