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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.





Acacia Pharma Group plc

Mike Bolinder, CEO

Gary Gemignani, CFO

+44 1223 919760 / +1 317 505 1280


Citigate Dewe Rogerson (Financial PR)

Mark Swallow, Frazer Hall, David Dible

+44 20 7638 9571


About Acacia Pharma


Acacia Pharma is 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. The Company has identified important and commercially attractive unmet needs in these areas that its product portfolio aims to address.


Acacia Pharma's first product, BARHEMSYS® (amisulpride injection) for postoperative nausea & vomiting (PONV), has been approved by the US FDA, with US launch planned for 2H 2020.


BYFAVO™ (remimazolam) for injection, a very rapid onset/offset IV benzodiazepine sedative is approved in the US for use during invasive medical procedures in adults lasting 30 minutes or less, such as colonoscopy and bronchoscopy. BYFAVO is in-licensed from Cosmo Pharmaceuticals for the US market, and US launch is planned for 2H 2020.


APD403 (intravenous and oral amisulpride), a selective dopamine antagonist for chemotherapy induced nausea & vomiting (CINV) has successfully completed one proof-of-concept and one Phase 2 dose-ranging study in patients receiving highly emetogenic chemotherapy.


Acacia Pharma is based in Cambridge, UK and its US operations are centred in Indianapolis, IN. The Company is listed on the Euronext Brussels exchange under the ISIN code GB00BYWF9Y76 and ticker symbol ACPH.

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Last Updated: 15-Jul-2020