Strongbridge Biopharma PLC acquired the U.S. rights to KEVEYIS from a unit of Taro Pharmaceutical Industries Ltd.
KEVEYIS was approved by the FDA in August 2015 to treat hyperkalemic, hypokalemic and related variants of primary periodic paralysis, a group of rare hereditary disorders that cause potentially severe episodes of muscle weakness or paralysis.
The drug has orphan drug exclusivity status in the U.S. through Aug. 7, 2022.
Strongbridge will provide Taro with upfront and deferred payments of $8.5 million in two installments. Taro is eligible to get additional future payments, subject to the achievement of certain sales unit milestones.
Taro will continue to manufacture the drug for Strongbridge under an exclusive supply agreement at least for the period of its orphan exclusivity, subject to certain commercial terms and conditions, including minimum supply purchases.
Strongbridge plans to commercially launch the drug in the U.S. in April 2017.