FDA approves Byfavo for procedural sedation

The US Food and Drug Administration has approved Byfavo (remimazolam) for injection for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less, marking the second approval for UK-based Acacia Pharma (Euronext: ACPH) this year, extending its portfolio of anesthesia products, and sending the firm’s shares up 10.8% to 3.28 euros by mid-morning today.

Acacia Pharma in-licensed the commercial rights to Byfavo for the US from Cosmo Pharmaceuticals in January 2020. Remimazolam was developed by Germany’s Paion, which will receive a milestone payment of 15 million euros ($16.8 million) from Cosmo and is entitled to tiered royalties on net sales in the USA ranging from 20% to 25%.

The approval of Byfavo will help to further strengthen Acacia Pharma’s financial resources, as previously announced, the company will now have access to an additional 25 million euros debt facility from Cosmo. Acacia Pharma will make a 30 million-euro upfront payment for the license of Byfavo to Cosmo, triggered by the approval, consisting of 15 million euros in cash and 15 million euros in ordinary shares of Acacia Pharma stock. The 10 million euros of net cash that Acacia Pharma will receive will be available to help fund the US launch of Byfa