Handok has entered a distributorship agreement with Amicus Therapeutics to sell the latter’s Galafold® in Korea.

Amicus Therapeutics is a global biotech company headquartered in both the United States and Britain and specializes in the research, development, and distribution of innovative new drugs particularly for rare metabolic diseases.

Galafold® (migalastat), which Handok seeks to import into Korea, is the only oral medication in the world for Fabry disease that can be administered to patients with amenable mutations. The drug is currently being marketed in the United States, the European Union, Switzerland, Australia, Canada, Israel, and Japan. Designated by the Korean government as an “urgent” drug in the developmental phase for treatment of rare disease, Galafold® received approval for Korea by the Ministry of Food and Drug Safety in late 2017 and included and covered by the National Health Insurance’s drug scheme on March 1, 2019.

Fabry disease is a rare condition that disables an enzyme known as alpha-galactosidase A. The result is rapid accumulation of glycolipids, which compromises the functions of a variety of other cells in the body, increasing the risk of fatal complications such as cardiovascular disease, stroke and renal failure.