Chimerix’s lead clinical asset, dordaviprone, is a novel first-in-class small molecule treatment in development for H3 K27M-mutant diffuse glioma, a rare, high-grade brain tumor that most commonly affects children and young adults. There are no US Food and Drug Administration (FDA)-approved therapies specifically for H3 K27M-mutant diffuse glioma patients; radiation is the most common treatment approach, the companies said.

A New Drug Application (NDA) for accelerated approval of dordaviprone in recurrent H3 K27M-mutant diffuse glioma was recently accepted and granted Priority Review by FDA. If approved in the US, dordaviprone may be eligible for a Rare Pediatric Disease Priority Review Voucher (PRV). Separately, dordaviprone is being investigated in a Phase 3 study, evaluating its use in newly diagnosed, non-recurrent H3 K27M-mutant diffuse glioma patients following radiation treatment, potentially extending this treatment option into the front-line setting.

“Adding dordaviprone to our oncology R&D pipeline will further diversify our portfolio with a medicine that addresses a significant unmet need with no other FDA-approved therapies and limited treatment options for this patient population. If approved, dordaviprone has the potential to rapidly become a standard of care for a rare oncology disease and also contribute durable revenue beginning in the near-term,” said Bruce Cozadd, CEO of Jazz Pharmaceuticals.

“We are excited to reach this agreement with Jazz Pharmaceuticals as they bring global scale to broaden our dordaviprone commercial strategy,” said Mike Andriole, CEO of Chimerix.

Under the terms of the agreement, Jazz will commence an all-cash tender offer to acquire all outstanding shares of Chimerix’s common stock, whereby Chimerix shareholders will be offered $8.55 per share in cash. Upon the successful completion of the tender offer, Jazz plans to acquire all shares not acquired in the tender through a second-step merger for the same consideration per share paid in the tender offer.