15 July 2020
Acacia Pharma Assigned US License for BYFAVO™ (remimazolam) by Cosmo Pharmaceuticals NV
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 – 15 July 2020: Acacia Pharma Group plc (“Acacia Pharma” or the “Company”) (EURONEXT: ACPH), a commercial stage biopharmaceutical company focused on developing and commercializing novel products to improve the care of patients undergoing serious medical treatments such as surgery, invasive procedures, or chemotherapy, announces that it has been assigned the US license to BYFAVO™ (remimazolam) for injection by Cosmo Pharmaceuticals NV. This assignment has the consent of PAION AG, the original developer of remimazolam and results from a mutual release agreement between Cosmo and PAION.
The terms of the license agreement that Acacia Pharma entered into in January 2020 remain unchanged but will now be between Acacia Pharma and PAION. Cosmo will no longer be a party to that agreement.
“We are very pleased to have been assigned the US license to BYFAVO following its very recent approval by the US Food and Drug Administration and are grateful for all the support provided by Cosmo,” commented Mike Bolinder, Acacia Pharma’s CEO. “This new direct arrangement with PAION will allow us to better collaborate and access their deep expertise on the benefits of BYFAVO as we look to begin the commercialization of this important new product for procedural sedation in adult patients, alongside BARHEMSYS®, in the months ahead.”
Alessandro Della Chà, CEO of Cosmo, said: “This assignment is important in order to let Acacia entertain a direct relationship with PAION. We look forward to continue to contribute to the success of BYFAVO as shareholders of both Acacia and PAION.”
Dr. Jim Phillips, CEO of PAION AG, commented: “We are very pleased that we have come to an agreement with Cosmo and Acacia, which will simplify what until now has been a three party relationship, and going forward we can interact directly with the Acacia team to support commercialization. With the recent market approval of BYFAVO in the US, we are pleased to now be able to have a direct relationship with the end-commercialization partner. We want to thank Cosmo for their support in the past years and look forward to continuing to work with them as an investor and shareholder.”
BYFAVO (remimazolam) for injection is a very rapid onset/offset intravenous benzodiazepine sedative for use during invasive medical procedures in adult patients lasting 30 minutes or less, such as during colonoscopy and bronchoscopy. Approximately 25 million such procedures take place annually in the US, of which around 90% use moderate sedation.
Cosmo in-licensed the US rights to BYFAVO from PAION AG in 2016 and together they have progressed the product candidate through to registration. BYFAVO is approved in the US and is indicated for the induction and maintenance of procedural sedation in adults lasting 30 minutes or less.
Forward looking statement
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