Press Releases

16 September 2021

Acacia Pharma Announces Initiation of Pivotal Study of Byfavo® in Pediatric Procedural Sedation

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

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Cambridge, UK and Indianapolis, US – 16 September 2021: 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 the initiation of its Food and Drug Administration (FDA)-mandated pivotal study investigating Byfavo® (remimazolam injection) in the moderate sedation of pediatric patients (the “Study”).

The study will enroll approximately 100 children aged up to and including 17 years at leading institutions across the United States and Denmark. The Study is expected to take 9-12 months to complete. If successful and upon approval by FDA of a supplemental New Drug Application for Byfavo, it is expected that the US label of Byfavo will be expanded to include moderate sedation for procedures in pediatric patients.

Dr Gabriel Fox, Chief Medical Officer, commented: “The need for moderate sedation in pediatric patients is substantial, covering a wide range of procedures, including, but not limited to, MRI and CT imaging, endoscopies, intravenous cannula placements, dental procedures, and painful wound and burn dressing changes. We are excited to be working with an outstanding group of pediatric sedation experts on this important initiative.” 

The Study, formally titled “A Phase 2/3, prospective, open-label trial evaluating the efficacy, safety, and pharmacokinetics of remimazolam for intravenous sedation in paediatric patients undergoing diagnostic and/or therapeutic procedures” ( Identifier: NCT04851717), underpins the Pediatric Study Plan for Byfavo agreed with FDA (as well as an equivalent plan agreed by co-sponsor PAION UK Ltd with the European Medicines Agency). As part of the US approval of Byfavo, FDA required the completion of the Study by July 2024; however, the Company has elected to accelerate the conduct of the Study significantly, because of the important unmet medical need for Byfavo in pediatric procedural sedation.


Acacia Pharma Group plc
Mike Bolinder, CEO
Gary Gemignani, CFO
+44 1223 919760 / +1 317 505 1280 

International Media
Mark Swallow, Frazer Hall, David Dible
MEDiSTRAVA Consulting
+44 20 7638 9571

Media in Belgium and the Netherlands
Chris Van Raemdonck
+32 499 58 55 31

US Investors
LifeSci Advisors
Irina Koffler
+1 917-734-7387


About Byfavo® (remimazolam injection)
US commercial rights to Byfavo were in-licensed from Cosmo Pharmaceuticals NV (“Cosmo”) in January 2020 and it was approved in July 2020 for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less which make up around 40m procedures a year in the US, including 25m gastro-intestinal procedures1 for an estimated >$1.5 billion annual total addressable market2.

1. iData Research, US Market Report Procedure Numbers for Gastrointestinal Endoscopic Devices February 2019; American Society of Anesthesiologists, Practice Guidelines for Moderate Procedural Sedation and Analgesia 2018; and Quantitative Market Research prepared by The Link Group for Cosmo Technologies (March 2019). 
2. Based on the calculation in (1) multiplied by the number of doses per patient at a WAC price of $39 per dose.

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) is available in the US for the management of postoperative nausea & vomiting (PONV).

Byfavo (remimazolam) for injection, a very rapid onset/offset IV benzodiazepine sedative is approved and launched 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 Paion UK Limited for the US market.

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 has its US headquarters in Indianapolis, IN and its R&D operations are centred in Cambridge, UK. The Company is listed on the Euronext Brussels exchange under the ISIN code GB00BYWF9Y76 and ticker symbol ACPH. 

Forward looking statements

This announcement includes forward-looking statements, which are based on current expectations and projections about future events. These statements may include, without limitation, any statements preceded by, followed by or including words such as "believe", "expect", "intend", "may", "plan", "will", "should", "could" and other words and terms of similar meaning or the negative thereof. Forward-looking statements may and often do differ materially from actual results. These forward-looking statements are subject to risks, uncertainties and assumptions about the Company and its subsidiaries and investments, including, among other things, the development of its business, trends in its operating industry, and future capital expenditures and acquisitions. By their nature, forward-looking statements involve risk and uncertainty because they relate to future events and circumstances. Any forward-looking statements reflect the Company's current view with respect to future events and are subject to risks relating to future events and other risks, uncertainties and assumptions relating to the Group's business, results of operations, financial position, prospects, growth or strategies and the industry in which it operates. Save as required by law or applicable regulation, the Company and its affiliates expressly disclaim any obligation or undertaking to update, review or revise any forward-looking statement contained in this announcement whether as a result of new information, future developments or otherwise. Forward-looking statements speak only as of the date they are made.


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