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November 21, 2013

Amicus obtains global rights for investigational Fabry disease drug

GlaxoSmithKline (GSK) and Amicus Therapeutics have announced that Amicus has secured sole rights to 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.

Fabry

GlaxoSmithKline (GSK) and Amicus Therapeutics have announced that Amicus has secured sole rights to 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.

Under the revised agreement, Amicus will have global 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 deal will see GSK further invest $3m in Amicus through an equity investment in a concurrent private placement in public equity (PIPE) transaction.

Amicus chairman and chief executive officer John Crowley said GSK has been an active development partner for the company on these programmes 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 programmes to major milestones into 2014."

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GSK is eligible to receive single-digit royalties on net sales for Fabry ERT and for migalastat HCl monotherapy, post-approval and sales-based milestones, as well as tiered royalties in the mid-teens in eight major markets outside the US.

"With this transaction, we are gaining worldwide rights to our first proprietary next generation co-formulated product, as well as migalastat HCl monotherapy."

The terms of the revised agreement have replaced the prior agreement signed in July 2012, which involved Amicus and GSK co-developing migalastat HCl globally and 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 programme meets certain regulatory and sales milestones."

Migalastat HCl is an investigational pharmacological chaperone being developed as a monotherapy and in combination with ERT to treat patients with Fabry disease.

It is designed to bind to and stabilise 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.


Image: Alpha galactosidase, the protein that is deficient in Fabry disease. Photo: courtesy of Grook Da Oger.

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