Harmony Biosciences announced the acquisition of Epygenix Therapeutics, Inc., accelerating its growth strategy by adding a rare epilepsy franchise to its expanding late-stage pipeline of innovative CNS assets.
"The acquisition of Epygenix gives us three distinct CNS franchises in late-stage development, each with a potential US peak sales opportunity of $1B - $2B," said Jeffrey M. Dayno, M.D., President and Chief Executive Officer at Harmony Biosciences. "We have been strategically building a robust and diverse pipeline of innovative CNS assets for rare diseases that has transformed our business. This acquisition builds on our leadership position in sleep/wake and our franchise in neurobehavioral disorders, allowing us to leverage our expertise in CNS and internal synergies to deliver new therapies to patients with unmet medical needs."
"Harmony shares our team's core values, including a commitment to patients and families living with Dravet syndrome and Lennox-Gastaut syndrome, where a significant unmet need for effective therapies remains," said Alex Yang, Chair and CEO of Epygenix Therapeutics. "Harmony's demonstrated expertise in drug development and commercialization will accelerate the full potential of these treatments and make a real difference in the lives of Dravet and LGS families."
The acquisition includes clemizole hydrochloride (EPX-100), a potent, oral, centrally acting serotonin (5HT2) agonist. It is currently in a pivotal registrational clinical trial for the treatment of Dravet syndrome in children and adults and is poised to enter Phase 3 for the treatment of Lennox-Gastaut syndrome. The proven mechanism of action of clemizole could potentially offer an improved product profile over currently available treatment options and improve daily functioning in patients living with Dravet syndrome and Lennox-Gastaut syndrome.
EPX-100 has received Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) from the FDA for both Dravet syndrome and Lennox-Gastaut syndrome. A second investigational product, EPX-200, is a potent, oral, centrally active and selective 5HT2C agonist, and is currently in IND-enabling studies. EPX-200 also received ODD from FDA for Dravet syndrome and Lennox-Gastaut syndrome as well as RPDD for Lennox-Gastaut syndrome.
Under the terms of the definitive agreement, Harmony paid $35 million in cash with the potential for payments of up to $130 million based on development and regulatory milestones. In addition, there are potential payments of up to $515 million if certain sales milestones are achieved.
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