FDA approval for Acacia Pharma technology
The US FDA has approved Acacia Pharma’s BYFAVO™ (remimazolam) for injection for the induction and maintenance of procedural sedation in adults undergoing surgical procedures lasting 30 minutes or less.
Cambridge-based Acacia in-licensed the commercial rights to BYFAVO for the US from Cosmo Pharmaceuticals NV in January. Remimazolam was developed by Paion AG.
The FDA approval will help to further strengthen Acacia Pharma’s financial resources. As previously announced, the company will now have access to an additional €25 million debt facility from Cosmo.
Acacia will make a €30 million upfront payment for the licence of BYFAVO to Cosmo, triggered by the approval, consisting of €15m in cash and €15m in ordinary shares of Acacia Pharma stock.
The €10 million of net cash that Acacia Pharma will receive will be available to help fund the US launch of BYFAVO.
Mike Bolinder, Acacia Pharma’s CEO, said: “We are very pleased to announce today the approval of BYFAVO in the US for procedural sedation in adult patients.
“This marks the second FDA approval of an Acacia Pharma product since the start of 2020 and another major milestone in our evolution into an integrated hospital pharmaceutical company with strong development and commercialisation capabilities.
“The addition of BYFAVO to our product portfolio strengthens our offering to anaesthesiologists and enables us to further leverage our commercial infrastructure.”
Acacia’s first product, BARHEMSYS® (amisulpride injection) was approved by the FDA on February 26 for the treatment and prevention of postoperative nausea and vomiting in adult patients. The company intends to launch both BARHEMSYS and BYFAVO in the US during the second half of 2020.