As a part of the expanded agreement, the companies will co-develop the present and future formulations of migalastat HCl for Fabry disease, such as GSK/JCR Pharmaceutical’s investigational enzyme replacement therapy (ERT).
In accordance with the agreement, AMICUS will commercialise all formulations of migalastat HCl in the US, while GSK will commercialise formulations in the rest of the world.
GSK will make an $18.6m equity investment in Amicus, bringing GSK’s total ownership stake in Amicus to 19.9%.
Marc Dunoyer, GSK rare diseases global head and GSK corporate executive team member, said the company strengthened its relationship with Amicus through the expanded Fabry collaboration and additional equity investment.
"This is an important step in our strategic vision, allowing us to undertake and fund an enlarged scientific programme with a view to turning molecules into medicines for rare diseases faster and more effectively than ever before," Dunoyer added.
Amicus and GSK will work on the development of three different uses of migalastat HCl for Fabry disease, Migalastat HCl monotherapy in Phase III, Migalastat HCl co-administered with ERT in Phase II and Migalastat HCl co-formulated with a proprietary preclinical ERT.
John Crowley, Amicus chairman and chief executive officer, said: "Through our expanded agreement, GSK is increasing its investment in the Fabry development programme and Amicus is transforming into a commercial-stage biopharmaceutical company within the US Amicus is leveraging its chaperone-ERT platform to advance migalastat HCl in multiple potential uses for patients with Fabry disease."
Amicus and GSK will share R&D costs for all formulations of migalastat HCl, with Amicus funding 25% and GSK funding 75% of these costs for monotherapy and co-administration during the remainder of 2012.
In 2013 and beyond, Amicus and GSK will share 40% and 60% of the costs, respectively, for co-formulation immediately and for all formulations.
Image: GlaxoSmithKline’s headquaters in Brentford, London, England. Photo: courtesy of Maxwell Hamilton.