PLYMOUTH MEETING, PA — Harmony Biosciences (Nasdaq: HRMY) announced its recent acquisition of Epygenix Therapeutics, Inc., marking a significant step into the rare epilepsy sector. This acquisition not only broadens Harmony’s late-stage pipeline but also sets the stage for addressing unmet needs in the treatment of Dravet and Lennox-Gastaut syndromes—severe forms of epilepsy.
Harmony Biosciences, already known for its sleep/wake disorder treatments, sees this acquisition as a key growth driver. “We’re expanding our CNS assets to include a promising epilepsy franchise, potentially reaching US peak sales between $1 billion and $2 billion,” stated Jeffrey M. Dayno, President and CEO of Harmony. The company aims to leverage its CNS expertise and internal resources to develop novel therapies for these underserved patient populations.
Epygenix Therapeutics brings to Harmony a portfolio including clemizole hydrochloride (EPX-100), a drug in advanced clinical trials for Dravet syndrome and poised for Phase 3 trials in treating Lennox-Gastaut syndrome. Clemizole is noted for its potential to offer a superior treatment option over existing therapies, potentially improving daily life for those affected by these conditions. Additionally, EPX-100 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA, highlighting its significance in treating these rare disorders.
Alex Yang, Chair and CEO of Epygenix, expressed optimism about the acquisition, emphasizing Harmony’s track record in drug development and commercialization as pivotal for advancing these treatments to market, thereby benefiting families grappling with Dravet and LGS.
The financial terms of the deal include an upfront payment of $35 million from Harmony, with additional milestone payments that could total up to $645 million. This includes both developmental, regulatory, and sales-based milestones, reflecting the high expectations and potential market impact of these treatments.
This acquisition not only signifies Harmony Biosciences’ commitment to diversifying its CNS treatment offerings but also spotlights the pharmaceutical industry’s focus on developing targeted therapies for rare diseases. By incorporating Epygenix’s assets, Harmony positions itself at the forefront of innovation in epilepsy treatment, promising a brighter future for patients and families affected by these challenging conditions.
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