TIDMACPH
This announcement contains inside information for the purposes
of Article 7 of the Market Abuse Regulation (EU) No 596/2014.
Acacia Pharma Announces Significant Continued Progress with
Formulary Uptake of BARHEMSYS(R) and BYFAVO(TM) in the US
Cambridge, UK and Indianapolis, US -- 1 July 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 that its FDA-approved products BARHEMSYS(R) and
BYFAVO(TM) are on track to meet its full year 2021 formulary
acceptance goals.
As of 30 June 2021:
-- BARHEMSYS is now on formulary at 201 institutions, against an FY2021
expectation of 300; this represents an increase of more than 80 accounts
since March 2021. To date, the formulary success rate for BARHEMSYS
continues to track in the mid-80% range, exceeding original expectations.
-- BYFAVO is now on formulary in 47 accounts, against an FY2021 expectation
of 150; this represents an increase of 40 accounts since March 2021. To
date, the formulary success rate for BYFAVO continues to track at or
above that for BARHEMSYS, also exceeding original expectations
Newly appointed Chief Commercial Officer Deb Hussain commented:
"My excitement in joining Acacia Pharma was based on our ability to
improve the lives of patients through the successful
commercialization of BARHEMSYS and BYFAVO, and our early US launch
efforts are delivering positive results. The rate of formulary
adoption we are achieving against the backdrop of restrictions
imposed by the Covid-19 pandemic is quite impressive, suggesting
the significant unmet needs patients and hospitals have in this
space. We will continue our commercial efforts in additional
targeted accounts and are very confident of further formulary wins
across the balance of the year."
Commenting on progress, Mike Bolinder, Chief Executive Officer,
added: "We are extremely encouraged with the acceptance of our
products, including at some of the largest institutions and
networks in the country. This is particularly noteworthy given the
current hospital environment that has yet to normalize from the
pandemic, resulting in significantly reduced physical access to
accounts and continued delays in formulary committee reviews. We
know that formulary adoption is the key first step in achieving
consistent and growing sales pull through starting in 2022, which
will allow us to build a long term, sustainable hospital products
franchise, thereby creating significant value for our
shareholders."
Regarding the unmet need that BARHEMSYS addresses in PONV, Dr
Richard Dutton, Chief Quality Officer of US Anesthesia Partners and
anesthesiologist at Baylor Scott & White Health, the largest
not-for-profit healthcare system in Texas and one of the largest in
the United States, noted: "BARHEMSYS provides an important option
for treating PONV in our patients who have failed our usual
prophylactic antiemetics -- a major unmet need -- and we are very
pleased to have it available on formulary across our network of
hospitals."
Regarding the utility of BYFAVO in practice, Dr Talmage Egan,
Chair of the Department of Anesthesiology at the University of
Utah, commented: "We are pleased to have added remimazolam to our
formulary and we are excited to explore how it may positively
impact our sedation practice. As a 'soft' benzodiazepine,
intentionally designed for more rapid metabolism and shorter
duration of effect, it may help us improve efficiencies in our
procedural suites such as gastrointestinal endoscopy treatment
rooms."
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 BARHEMSYS(R) (amisulpride injection)
BARHEMSYS was approved in February 2020 in the US with a broad
label for the treatment and prevention of postoperative nausea
& vomiting (PONV). It is the first and only antiemetic approved
for the rescue treatment of PONV in patients who have failed prior
prophylaxis. Approximately 16m surgical patients each year in the
US suffer from PONV despite receiving prophylaxis(1) with an
estimated $2.7 billion annual total addressable market(2) .
About BYFAVO(TM) (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(3) for an estimated >$1.5 billion
annual total addressable market(4) .
References
1. Calculations based on available procedural data, applied
Compound Annual Growth Rate and quantitative market research
responses as follows: National Hospital Discharge Survey, 2006;
National Survey of Ambulatory Surgery, 2006 (as revised in 2009);
Source Healthcare; NCHS 2005; Life Science Strategy Group, LLC
Market Research; Apfel et al.,2004.
2. Based on the calculations in (1) multiplied by the number of
doses per patient at a WAC price of $85 per 10mg dose.
3. 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).
4. Based on the calculation in (4) 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(TM) (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
July 01, 2021 01:00 ET (05:00 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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