Acacia Pharma Announces Brief Extension of FDA Review Period for NDA for BYFAVO™, an Ultra-short Acting and Reversible Anesthetic for Procedural Sedation

This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014.

Cambridge, UK and Indianapolis, US – 12 March 2020: Acacia Pharma Group plc (“Acacia Pharma”, the “Group” or the “Company”) (EURONEXT: ACPH), a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures or cancer chemotherapy, announces that the US Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for BYFAVO™ (remimazolam) by up to 90 days in order to complete its review of additional data submitted in January and February 2020.

FDA has set a new Prescription Drug User Fee Act (PDUFA) goal of reviewing and acting on the NDA of no later than 5 July 2020 (previous PDUFA target date was 5 April 2020).

Acacia Pharma in-licensed the US commercialization rights to BYFAVO from Cosmo Pharmaceuticals N.V. in January 2020.

About BYFAVO™

BYFAVO (remimazalom) is an ultra-short-acting and reversible intravenous benzodiazepine sedative/anesthetic designed for use during invasive medical procedures, such as during colonoscopy and bronchoscopy. Approximately 24.5 million such procedures take place annually in the US, of which around 90% use moderate sedation.

BYFAVO has demonstrated efficacy and safety in an extensive clinical trial programme involving around 2,400 volunteers and patients. Data so far indicate that remimazolam has a rapid onset and offset of action combined with a good cardio-respiratory safety profile. BYFAVO is designed to act more quickly than the available alternatives of the same pharmaceutical class for the same indication (e.g. midazolam) and can be reversed with flumazenil to rapidly terminate sedation or anesthesia if necessary.

Cosmo in-licensed the US rights to BYFAVO from Paion AG in 2016 and together they have progressed the product candidate through to registration. The NDA for BYFAVO has been filed with the US FDA in April 2019 and the new target PDUFA action date is 5 July 2020.