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Taro Pharmaceutical Industries Ltd. announced the sale of US rights to Keveyis (dichlorphenamide) to Strongbridge Biopharma plc (Strongbridge), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet need. Keveyis was approved by the US Food and Drug Administration (the FDA) in August 2015 to treat primary hyperkalemic and hypokalemic periodic paralysis, a group of rare hereditary disorders that cause episodes of muscle weakness or paralysis. Keveyis has orphan designation status through August 2022.
Under the terms of the purchase agreement, Strongbridge will provide Taro with upfront and deferred payments of $8.5 million in two installments; Taro is also eligible to receive additional future payments upon the achievement of certain sales unit milestones. Strongbridge expects to commercially launch Keveyis in the U.S. in April 2017. Taro has agreed to continue to manufacture Keveyis for Strongbridge, under an exclusive supply agreement at least for the period of Keveyis orphan exclusivity, subject to certain commercial terms and conditions, including minimum supply purchases.
“We are proud of our work in making Keveyis the first FDA-approved treatment option for people living with primary periodic paralysis,” said Kal Sundaram, chief executive officer of Taro. “In maintaining our commitment to patients, we have selected a partner in this sale with the expertise to reach the patients and physicians needed to improve patient outcomes and deepen understanding of the disease.”
Since ceasing commercialization in May 2016, Taro has been supplying Keveyis to patients through a compassionate use program. Strongbridge is committed to continuing this program through the expected launch in April 2017, and is committed to working with existing US Keveyis patients to ensure continuity of treatment.
