Amicus Therapeutics and GlaxoSmithKline have expanded their collaboration to develop and commercialize the investigational pharmacological chaperone migalastat HCl for Fabry disease.
The expanded alliance includes co-development of all current and future formulations of migalastat HCl, including a co-formulation of migalastat HCl with GSK/JCR Pharmaceutical Co.'s enzyme replacement therapy (ERT) for Fabry disease. Amicus will have commercial rights to all Fabry products in the U.S. and GSK will commercialize the products in the rest of world. Also, GSK has increased its ownership of Amicus with an $18.6 million investment in common stock, bringing its total ownership stake to 19.9%.
"We have strengthened our relationship with Amicus through the expanded Fabry collaboration and additional equity investment in the Company," said Marc Dunoyer, Global Head of GSK Rare Diseases. "Amicus has a very successful track record as our development partner, and long-standing relationships with the Fabry community. We look forward to their leadership in the U.S. commercialization of now several potential medicines for patients with Fabry disease. This is an important step in our strategic vision, allowing us to undertake andfund an enlarged scientific program with a view to turning molecules into medicines for rare diseases faster and more effectively than ever before."
John F. Crowley, chairman and chief executive officer of Amicus said, "GSK has added significant value to the Fabry program through its global scale and capabilities as well as the dedicated focus of GSK Rare Diseases. Through our expanded agreement, GSK is increasing its investment in the Fabry development program and Amicus is transforming into a commercial-stage biopharmaceutical company within the U.S. Amicus is leveraging its chaperone-ERT platform to advance migalastat HCl in multiple potential uses for patients with Fabry disease."