01 July 2021
Acacia Pharma Announces Significant Continued Progress with Formulary Uptake of BARHEMSYS® and BYFAVO™ in the US
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 – 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® and BYFAVO™ 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.”
About BARHEMSYS® (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 prophylaxis1 with an estimated $2.7 billion annual total addressable market2.
About BYFAVO™ (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 procedures3 for an estimated >$1.5 billion annual total addressable market4.
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® (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.
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.