Strongbridge Biopharma Acquires U.S. Rights to KEVEYIS From Taro

12/23/16

DUBLIN, Ireland and TREVOSE, Pa., Dec. 23, 2016 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc, (Nasdaq:SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that the Company has acquired the U.S. rights to KEVEYIS® (dichlorphenamide) from a subsidiary of Taro Pharmaceutical Industries Ltd.. KEVEYIS was approved by the U.S. Food and Drug Administration (FDA) in August 2015 to treat hyperkalemic, hypokalemic, and related variants of Primary Periodic Paralysis, which is a group of rare hereditary disorders that causes potentially severe episodes of muscle weakness and/or paralysis. KEVEYIS has orphan drug exclusivity status in the U.S. through August 7, 2022.

“The acquisition of KEVEYIS is transformational for Strongbridge and expands our rare disease portfolio to include neuromuscular diseases,” said Matthew Pauls, president and chief executive officer of Strongbridge. “We look forward to working closely with the Primary Periodic Paralysis community to help make a meaningful difference in the lives of those affected by this rare and underserved disease,” Pauls added.

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.

Since May 2016, Taro has been supplying KEVEYIS to patients through a compassionate use program. Strongbridge will continue this program through at least April 1, 2017. Strongbridge is committed to working with existing U.S. KEVEYIS patients to ensure continuity of treatment. KEVEYIS patients may call 1-844-KEVEYIS for more information.

Locust Walk served as Strongbridge’s transaction advisor.

About Strongbridge Biopharma

Strongbridge Biopharma is a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs. Strongbridge's first commercial product is KEVEYIS® (dichlorphenamide), the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of Primary Periodic Paralysis. KEVEYIS has orphan drug exclusivity status in the U.S. through August 7, 2022. In addition to establishing this neuromuscular disease franchise, the Company has a clinical-stage pipeline of therapies for rare endocrine diseases. Strongbridge's lead compounds include COR-003 (levoketoconazole), a cortisol synthesis inhibitor currently being studied for the treatment of endogenous Cushing's syndrome, and COR-005, a next-generation somatostatin analog (SSA) being investigated for the treatment of acromegaly, with potential additional applications in Cushing's syndrome and neuroendocrine tumors. Both COR-003 and COR-005 have received orphan designation from the U.S. Food and Drug Administration and the European Medicines Agency. For more information, visit www.strongbridgebio.com.

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