GlaxoSmithKline (GSK) and Amicus Therapeutics have announced that Amicus has received global rights for the global drug development, regulatory and commercial activities of migalastat HCl as a monotherapy and in combination with enzyme replacement therapy (ERT) for Fabry disease.
As part of the revised deal, Amicus will have sole rights for the next-generation Fabry ERT (migalastat HCl co-formulated with ERT) as well as migalastat HCl monotherapy, while GSK will be eligible for future regulatory and commercial milestone payments, as well as royalty payments.
The revised agreement will see GSK further invest $3m in Amicus through an equity investment in a concurrent private placement in public equity (PIPE) transaction.
GSK is eligible to receive single-digit royalties on net sales for Fabry ERT and for migalastat HCl monotherapy, it will also get post-approval and sales-based milestones as well as tiered royalties in the mid-teens in eight major markets outside the US.
The terms of the revised deal have replaced the prior agreement signed in July 2012, under which Amicus and GSK were co-developing migalastat HCl globally, while GSK had rights to commercialise migalastat HCl outside the US.
GSK chairman of R&D Moncef Slaoui said, "GSK will continue to support Amicus through our equity investment and share in the future value of migalastat HCl as the Fabry program meets certain regulatory and sales milestones."
Amicus chairman and CEO John Crowley said GSK has been an active development partner for the company on these programs for three years.
"With this transaction we are gaining worldwide rights to our first proprietary next generation co-formulated product, as well as migalastat HCl monotherapy," Crowley said.
"We look forward to advancing these programs to major milestones into 2014."
Migalastat HCl is designed to bind to and stabilise, or 'chaperone' a patient's own alpha-galactosidase A (alpha-Gal A) enzyme in those with genetic mutations that are amenable to this chaperone in a cell-based assay.