Acacia Pharma Announces Submission and Validation of Marketing Authorization Application for BARHEMSYS® (amisulpride injection) in Major European Markets
29 September 2021 - 03:00PM
Acacia Pharma Announces Submission and Validation of Marketing
Authorization Application for BARHEMSYS® (amisulpride injection) in
Major European Markets
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 – 29
September 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 that its Marketing Authorization
Application (MAA) for BARHEMSYS® (amisulpride injection) has been
submitted, validated and is now under formal review in major
European markets. The review process is expected to be completed by
Q3/2022.
BARHEMSYS was approved in February 2020 by the
Food and Drug Administration (FDA) for use in the United States to
prevent and treat postoperative nausea & vomiting (PONV) and
became commercially available in August 2020.
The MAA submission includes data from four
positive Phase 3 studies investigating BARHEMSYS, including the
first ever randomized, controlled trial to show successful
treatment of active PONV in patients who have failed prior
prophylaxis. More than 3,300 surgical patients and healthy
volunteers were enrolled in the BARHEMSYS clinical development
program.
“BARHEMSYS was successfully launched in the US
last year via our own commercial infrastructure and we are now
making good progress to making it available in Europe for the many
millions of surgical patients who suffer from PONV each year,”
commented Mike Bolinder, Acacia Pharma’s CEO. “We
own global rights to BARHEMSYS and, as we have stated, are pursuing
a partnership strategy for commercializing the product outside the
US market. We are working diligently to progress international
licensing agreements ahead of the product’s anticipated European
approval in 2022.”
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®
BARHEMSYS is a selective dopamine-2 (D2) and
dopamine-3 (D3) receptor antagonist, which Acacia Pharma has
developed and protected for the management of PONV.
BARHEMSYS is 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
www.BARHEMSYS.com
Contacts
Acacia Pharma Group plcMike
Bolinder, CEOGary Gemignani, CFO+44 1223 919760 / +1 317 505
1280IR@acaciapharma.com
MEDiSTRAVA Consulting (Financial
PR) Frazer Hall, David Dible, Mark Swallow+44 20 7638
9571acaciapharma@citigatedewerogerson.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.
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 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 2/3 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 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
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