Taro Pharmaceutical Industries Ltd. in Hawthorne announced it has sold the U.S. rights to its drug brand Keveyis to Strongbridge Biopharma plc, a commercial-stage biopharmaceutical company based in Dublin, Ireland, and suburban Philadelphia that develops and markets therapies for rare diseases with significant unmet need. Taro last spring halted commercial sales and promotion of the drug.
Strongbridge in the deal will make upfront and deferred payments of $8.5 million in two installments to Taro. It also stands to receive additional future payments as certain sales unit milestones are achieved.
Keveyis, generically named dichlorphenamide, in August 2015 was approved in tablet form by the U.S. Food and Drug Administration to treat primary hyperkalemic and hypokalemic periodic paralysis, a group of rare hereditary disorders that cause episodes of muscle weakness or paralysis and affects an estimated 5,000 people in the U.S., according to Taro.
The FDA in 2015 designated Keveyis an orphan drug, effective through August 2022. The designation, which qualifies the drug’s sponsor for tax credits for clinical testing and other development incentives, is given to drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people in the U.S. or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.
Taro Pharmaceuticals officials last May announced the company was stopping commercial sales and marketing of Keveyis, but would make the drug available to distributors at no cost for patients with primary periodic paralysis. Although the drug developer expected to treat only a few hundred patients, reaching them proved more difficult than anticipated and sales totaled less than $1 million when halted.
Taro officials said Strongbridge expects to commercially launch Keveyis in the U.S. in April. Until then, the Irish company will continue Taro’s compassionate-use program for Keveyis patients. Taro will continue to manufacture the drug for Strongbridge under an exclusive supply agreement at least for the period of the drug’s exclusive orphan status with the FDA.
“We are proud of our work in making Keveyis the first FDA-approved treatment option for people living with primary periodic paralysis,” Taro CEO Kal Sundaram said. “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.”
Founded in Israel in 1950, Taro Pharmaceutical Industries Ltd. Is a publicly traded company listed on the New York Stock Exchange. Its majority owner is Sun Pharmaceutical Industries Ltd. in India.