Harmony Biosciences has successfully acquired Epygenix along with its late-stage epilepsy drug for a $35 million upfront payment and an additional $600 million contingent on certain conditions being met.
The drug acquired under this deal will join two other existing late-stage candidates in Harmony’s pipeline, including EPX-100 and another one meant to treat children suffering from a rare epilepsy condition called Lennox-Gastaut syndrome. EPX-100 is at the heart of these late-stage pipelines and is meant to treat Dravet syndrome in both adults and children.
Company investors, analysts, and observers have expressed enthusiasm and positive outlooks over this purchase. Harmony President and CEO Jeffrey Dayno went as far as to say, “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.”
Mizuho analysts have also expressed enthusiasm about this acquisition and the company’s progress at large. Their enthusiasm is not just limited to them but extends to investors, who they shared in an announcement are “very pleased” with how the situation is developing.
Beyond investor and analyst optimism about the acquisition, a larger positive indicator has been the spike in company share price after markets opened following the announcement. Share prices rose 13% from $29.25 to $33.04 following the announcement.
After the company welcomed Bioproject’s orexin-2 inhibitor under its fold in early April, this is the company’s second significant acquisition in terms of business development in a month. The orexin-2 inhibitor will be tested as a narcolepsy treatment by the biotech and was bought for $25.5 million, with an additional $370 million in milestone payments promised.
The target has been notoriously hard to tackle, especially in light of the fact that other companies such as Takeda and Jazz Pharmaceuticals have also set their sights on and struggled in this field.
Harmony already has a budding sleep disorder franchise spearheaded by its approved narcolepsy med, Wakix. The purchase of TPM-1116 from Bioproject is meant to add more dimension to it. In the first quarter of this year alone, the drug has brought in over $154 million in revenue, a 30% hike compared to what it generated at the same time last year.
To continue building on this success, Harmony plans to submit a supplemental new drug application to the Food and Drug Administration (FDA) to get the drug approved for idiopathic hypersomnia treatment, a condition marked by excessive sleepiness. The application will be submitted to the FDA in the second half of this year.
Additionally, the company plans to develop a new formulation for the drug, with a tentative PDUFA date announced for sometime in 2026.
