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 -- 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(R)
(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(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 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
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www.BARHEMSYS.com
Contacts
Acacia Pharma Group plc
Mike Bolinder, CEO
Gary Gemignani, CFO
+44 1223 919760 / +1 317 505 1280
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IR@acaciapharma.com
MEDiSTRAVA Consulting (Financial PR)
Frazer Hall, David Dible, Mark Swallow
+44 20 7638 9571
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acaciapharma@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(R) (amisulpride
injection) is available in the US for the management of
postoperative nausea & vomiting (PONV).
BYFAVO(R) (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
(END) Dow Jones Newswires
September 29, 2021 01:00 ET (05:00 GMT)
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