UCB said today it has acquired rights to Proximagen’s New Drug Application (NDA)-bound antiepilepsy candidate Midazolam Nasal Spray (USL261) for up to $370 million.
Midazolam is being developed as a rescue treatment for acute repetitive seizures (ARS, also known as serial, recurrent, or cluster seizures) in patients with epilepsy. UCB said it plans to file an NDA with the FDA for Midazolam later this year. The treatment has been granted the FDA’s orphan drug and fast track designations.
“There is a real and pressing need for effective and convenient rescue treatments in ARS that rapidly end ongoing seizures as well as those that prevent seizure reoccurrence,” UCB CEO Jean-Christophe Tellier, M.D., said in a statement. “Midazolam Nasal Spray has delivered strong Phase III results. Our acquisition of this program, when approved, will expand and diversify the treatment choices we are able to provide to the epilepsy community, complementing our strong internal portfolio and building on our extensive knowledge, passion, and expertise in the field of epilepsy.”
Designed for intranasal delivery without active inhalation, Midazolam last year generated positive Phase III results, with Proximagen saying the nasal spray met its primary efficacy endpoint in the ARTEMIS1 (Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray) trial.
That endpoint was treatment success, defined as achieving both of the following: (1) termination of seizure(s) within 10 minutes after study drug administration, and (2) no recurrence of seizure(s) beginning 10 minutes after administration of study drug to six hours after study drug administration.
UCB says Midazolam will complement its existing pipeline of epilepsy treatments. That pipeline is now led by the Phase II candidate padsevonil/UCB0942 (PPSI), with another antiepilepsy candidate in Phase I, radiprodil/UCB3491.
UCB agreed to pay Proximagen $150 million cash upfront, and up to $220 million tied to achieving regulatory approval and sales-based milestones.
In acquiring Midazolam rights, UCB reasons that the nasal spray will offer an improved treatment option over currently commonly prescribed drugs for ARS, rectally administered benzodiazepines, such as diazepam.
“Rescue treatment options for ARS have historically been very limited. As a global leader in epilepsy, with a pioneering commitment to improving patient value, UCB was the natural choice to progress the development journey of midazolam nasal spray” added Bill Pullman, M.D., Ph.D., CSO and president, Proximagen.
The deal is expected to close in the second quarter, subject to customary closing conditions that include the satisfaction of the notification and waiting period requirements of the Hart–Scott–Rodino Act.