UCB offers $370M for Proximagen’s epilepsy spray, with NDA to follow

UCB plans to bolster its epilepsy portfolio by acquiring a nasal spray developed by Proximagen, agreeing to pay $150 million upfront, with further payments of up to $220 million also in the cards. 

The midazolam-based spray, known as USL261, is designed to be delivered without being actively inhaled, and is designed as a rescue treatment for recurring or cluster seizures. After being fast-tracked by FDA and granted orphan drug status, this formulation has come through phase 3. Belgium-based UCB says it expects to submit an NDA to U.S. regulators before the end of the year.

Because repetitive seizures are commonly treated with rectally administered drugs such as diazepam, UCB hopes the nasal spray will provide a, shall we say, less-invasive option, especially in social settings. The companies are expected to close the deal before July, the pair said in a statement

Midazolam has been previously available as an anesthetic in several forms—and infamously, as part of the drug cocktail for executions by lethal injection—but has also been used off-label for the treatment of adult and pediatric epileptic seizures. An oral solution for children with seizures, Buccolam, received the first European approval back in 2011.

If approved, USL261 will join UCB’s suite of epilepsy treatments, including Briviact, Vimpat and Keppra, which together represented over $2.2 billion in net sales last year, according to the company. And recently, UCB also launched a small molecule development program for cognitive disorders following $20 million in funding from Johnson & Johnson, Novo Nordisk and V-Bio Ventures.

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Meanwhile, Proximagen has been the subject of a few lucrative acquisitions over the past few years. After being fully bought out by generics manufacturer Upsher-Smith Laboratories in a $553 million deal in 2012, Proximagen’s U.K. drug discovery and development operations were purchased by BenevolentAI for an undisclosed sum in February.

BenevolentAI’s founder, Ken Mulvany, a former Proximagen CEO himself, said the acquisition will allow the company to integrate artificial intelligence across every stage of the development process.