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 -- 13 December 2021: 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 cancer chemotherapy, announces the
successful completion of its post-approval requirement clinical
trial investigating the effects of BARHEMSYS(R) (amisulpride
injection) in individuals with severe renal impairment.
The study showed no clinically relevant difference in the
pharmacokinetics, electrocardiogram (ECG) parameters or safety
profile of BARHEMSYS between individuals with or without severe
renal impairment. No adverse events were recorded in any
subject.
The clinical trial was required by the US Food and Drug
Administration (FDA) as part of the February 2020 approval of
BARHEMSYS for the prevention and treatment of postoperative nausea
and vomiting (PONV). It was conducted at a specialist Phase 1 unit
in Florida and enrolled six subjects with severe renal impairment
(defined as an estimated glomerular filtration rate below 30
mL/min/1.73 m(2) ) and six matched healthy volunteers. Participants
received a single 10 mg intravenous dose of BARHEMSYS, followed 24
hours later by a single 10 mg oral dose of the active ingredient,
amisulpride.
"We are pleased to have completed this study in a timely
fashion, despite the challenges associated with running clinical
trials during the COVID-19 pandemic, and are delighted with the
uniformly positive results," commented Dr. Gabriel Fox, Acacia
Pharma's Chief Medical Officer. "We plan to submit the data to FDA
as soon as possible and believe the results will support amendment
of the BARHEMSYS label to include use in patients with severe renal
impairment. We also plan to publish the results of the study in a
peer-reviewed journal during 2022. We extend our thanks to the 12
individuals who took part in the study and to the healthcare
professionals who assisted in its conduct."
About PONV
PONV is a common complication of surgery, occurring in
approximately 30% of surgical patients and up to 80% of high-risk
patients. It is associated with the use of anesthetic gases and
opioid painkillers and is particularly common following
gynecological, abdominal, breast, eye, and ear operations,
especially those lasting an hour or more. PONV has been ranked as
the most undesirable of all surgical complications in some patient
surveys, even worse than pain.(1)
About BARHEMSYS(R)
BARHEMSYS is a selective dopamine-2 (D(2) ) and dopamine-3 (D(3)
) receptor antagonist, which Acacia Pharma has developed and
protected for the management of PONV.
BARHEMSYS is approved in the US and indicated in adults for:
-- treatment of PONV in patients who have received antiemetic prophylaxis
with an agent of a different class or who have not received prophylaxis
-- prevention of PONV, either alone or in combination with an antiemetic of
a different class
https://www.globenewswire.com/Tracker?data=-I2PBk5JsSBgOS5-f7hIrGU--koAZbxbtSzrWV93WCoYyK1BVgWAj0URX9mB3ikjEeW2TAiv6QO5F1hiErkETA==
www.BARHEMSYS.com
Contacts
Acacia Pharma Group plc International Media
Mike Bolinder, CEO Frazer Hall, Mark Swallow, David
Gary Gemignani, CFO Dible
+44 1223 919760 / +1 317 505 1280 MEDiSTRAVA Consulting
mailto:IR@acaciapharma.com IR@acaciapharma.com +44 20 7638 9571
mailto:acaciapharma@medistrava.com
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 mailto:chrisvanraemdonck@telenet.be
mailto:ikoffler@lifesciadvisors.com chrisvanraemdonck@telenet.be
ikoffler@lifesciadvisors.com
----------------------------------------------- ------------------------------------
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.
Barhemsys(R) (amisulpride) injection is a selective dopamine
(D(2) and D(3) ) receptor antagonist approved and available in the
US for the treatment and prevention of postoperative nausea &
vomiting (PONV) in adult patients.
Please see full prescribing information, including Important
Safety Information, at
https://www.globenewswire.com/Tracker?data=-I2PBk5JsSBgOS5-f7hIrNW5JkHB0Wqp6xRwsRV3P8SuJjzeXw_GQNIbIq6JYz18f3R3JR4gHbbuVM9ohehi2ZNiOSaUNWNOcmg-_Dx8UtzFWKOZjzcsp3rdPX_cehdesfkdx73BbWQS0r0f180RfFLvpnKLAsoJdFXOEI_ZLIbX4eLjFMSEmxb3Zvzg-NTbRpvRDCiyY7-YHmqgiOQq6P4Rp5OZhtuWB7uMNYOacno=
www.BARHEMSYS.com.
Byfavo(R) (remimazolam) for injection, is an IV benzodiazepine
sedative approved and available in the US for the induction and
maintenance of procedural sedation in adults undergoing procedures
lasting 30 minutes or less. Byfavo is in-licensed from Paion UK
Limited for the US market.
Please see full prescribing information, including Important
Safety Information and Boxed Warning, at
https://www.globenewswire.com/Tracker?data=-I2PBk5JsSBgOS5-f7hIrBPD2-E46KyPut6k13je0TngXNZiOTXiMzDfMyjnGD_j7Fp-5U22Psd3kFkoiNDi7FayZs7mqOULs7h0WW32KQRFzavCCIR3MW1IJspHCQyOasqZ_xhCNzIIFNkyrX0vVyCFN99_7dHJ5ki-4Z_H3-4mO46DNcA92OHImyHkGvSO3AEZpjqHvIdSz0YNEtZM-zRSpGj1qpGgBX9cGw79Amo=
www.BYFAVO.com.
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.
This release is intended for investors and media only.
https://www.globenewswire.com/Tracker?data=-I2PBk5JsSBgOS5-f7hIrH0HmAi_tMemEqAlCTVz6kP2leVMZtOLNPyn46j9GEo_nCEuaVwNeBCW9beSGO6x__7WCiB7lUUbyv0GfBQ5cU_Udo1N4AxCuWhKuyOlcJtFvJ7D1O5rHBQYL2KK--p-ZYs-8DLS-jdfjq5uzkVZRpxg7xWyxjU0i1RYOIJnIqjbc6cZuxW07NKR2kqS41SNtutDyKrS-i2n3oHz206HpxpqDG8shYIftzMHCJFTbV4smoKNIqBI5TlX8BSYLIY4xQ==
www.acaciapharma.com
Forward looking statement
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,
prospectus, 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.
Reference
1. Gan TJ, et al. Anesth Analg. 2014;118(1):85-113
(END) Dow Jones Newswires
December 13, 2021 01:00 ET (06:00 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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