Pharma BD Deal Intelligence
On April 30, 2024, Harmony Biosciences acquired Epygenix Therapeutics, adding a late-stage rare epilepsy franchise to its CNS pipeline. Harmony paid Epygenix's former stockholders $35.0 million upfront (less a working capital adjustment) and is obligated to pay up to $130.0 million on achievement of development and regulatory milestones plus up to $515.0 million on sales-based milestones, for total potential consideration of up to $680 million. The lead asset, EPX-100 (clemizole hydrochloride), was in a Phase 3 study in Dravet syndrome in adults and children, with a second Phase 3 study in children with Lennox-Gastaut syndrome planned. Through the acquisition Harmony obtained an exclusive license covering the use of clemizole, initially for Dravet and Lennox-Gastaut syndromes.
Assessment window: 5yr post-close.
Note: this deal's 5-year assessment window closes Apr 2029; the outcome grade above is a projected assessment, not yet finalized.
Lennox-Gastaut syndrome is a childhood-onset epileptic encephalopathy with multiple seizure types, characteristic slow spike-and-wave EEG and progressive cognitive impairment persisting into adulthood.
Epygenix was preparing to launch a second Phase 3 study of EPX-100 in children with Lennox-Gastaut syndrome at the time of the acquisition, extending the clemizole franchise beyond Dravet.
Dravet syndrome is a severe genetic developmental and epileptic encephalopathy, most often driven by SCN1A loss-of-function, presenting with prolonged febrile seizures in infancy and persistent drug-resistant epilepsy.
Fenfluramine (Fintepla) and cannabidiol (Epidiolex) anchor current branded therapy alongside stiripentol and clobazam. EPX-100 (clemizole) was advanced as an orally available serotonergic agent identified through zebrafish phenotypic screening.
Harmony Biosciences acquired Epygenix for $35.0M upfront plus up to $130.0M in development/regulatory milestones and up to $515.0M in sales milestones, adding EPX-100 (clemizole) in Phase 3 for Dravet syndrome.
Harmony confirmed in its FY2024 annual report that the acquisition conveyed an exclusive license to clemizole, initially for Dravet syndrome and Lennox-Gastaut syndrome.
| Deal | Year | Value | Outcome |
|---|---|---|---|
| Harmony Biosciences / Epygenix Therapeutics (this deal) | 2024 | $680M | 70 |
| Harmony Biosciences / Zynerba Pharmaceuticals Inc | 2023 | $200M | — |
| Nuvation Bio Inc. / AnHeart Therapeutics, Ltd. | 2024 | — | 100 |
| Novo Holdings A/S / Catalent (manufacturing sites) | 2024 | $11.0B | 81 |
| Novartis AG / PTC Therapeutics Inc. | 2024 | $2.9B | 80 |
| Vertex Pharmaceuticals Incorporated / Alpine Immune Sciences | 2024 | $4.9B | 78 |
| Johnson & Johnson / Shockwave Medical | 2024 | $13.1B | 76 |
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