Leerink says Galafold settlement with Teva ‘a near best-case outcome’ for Amicus

Leerink analyst Joseph Schwartz notes Outperform-rated Amicus Therapeutics (FOLD) disclosed the settlement of the Galafold patent litigation with Teva Pharmaceuticals (TEVA), allowing generic entry in 2037. While there are other ANDA filers, the firm thinks this is an encouraging step forward for the broader Galafold litigation and suggests that other parties may also settle. As disclosed today, Amicus has granted Teva a license to market a generic version of Galafold beginning on January 30, 2037. Moreover, the parties will terminate all ongoing Hatch-Waxman ligation. Considering some Galafold patents expire in the late 2020s and the risk of a skinny label approval, Leerink believes this settlement in the late 2030s is a near best-case outcome for Amicus. This potentially provides the company with another 10-plus years of exclusivity in the U.S. for Galafold, which continues to launch well and is on track for greater than $450M in sales this year.