TIDMACPH
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 -- 16 September 2021: 07:00
CET 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(R)
(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"
(ClinicalTrials.gov 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.
Contacts
Acacia Pharma Group plc International Media
Mike Bolinder, CEO Mark Swallow, Frazer Hall, David
Gary Gemignani, CFO Dible
+44 1223 919760 / +1 317 505 1280 MEDiSTRAVA Consulting
IR@acaciapharma.com +44 20 7638 9571
acaciapharma@medistrava.com
US Investors Media in Belgium and the Netherlands
LifeSci Advisors Chris Van Raemdonck
Irina Koffler +32 499 58 55 31
+1 917-734-7387 chrisvanraemdonck@telenet.be
ikoffler@lifesciadvisors.com
About Byfavo(R) (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 procedures(1) for an estimated >$1.5 billion
annual total addressable market(2) .
References
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(R) (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.
www.acaciapharma.com
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.
(END) Dow Jones Newswires
September 16, 2021 01:00 ET (05:00 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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