Amicus is a global patient-focused biotechnology company engaged in the discovery, development and commercialization of a diverse set of novel treatments for patients living with devastating rare and orphan diseases. The lead product, migalastat HCl is a small molecule that can be used as a monotherapy and in combination with enzyme replacement therapy (“ERT”) for Fabry disease. Migalastat was approved for use in the EU in May 2016 under the brand name Galafold™ as a first-line therapy for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease and who have an amenable mutation. The approved label includes 313 Fabry-causing mutations, which represent up to half of all patients with Fabry disease. As of June 30, 2017, Amicus has been authorized to commercialize GalafoldTM in 33 countries and over 150 Fabry patients receiving GalafoldTM compared to approximately 100 in April 2017. Additionally, based on a series of discussions with and written communication received from the FDA, the FDA has informed Amicus that it may now submit an NDA for migalastat. Amicus plans to submit an NDA to the FDA for migalastat for Fabry disease in the fourth quarter of 2017.