Cambridge - 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 today that BYFAVO (remimazolam) has been launched and is now commercially available in the US for order and delivery to customers through major wholesalers and specialty distributors.

BYFAVO was approved by the US Food and Drug Administration (FDA) on 2 July 2020 for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. It received its Schedule IV designation from the US Drug Enforcement Administration (DEA) on 6 October 2020, finalizing the approval process and clearing the way for final packaging and shipping to the US.

Acacia Pharma has built critical sales, marketing, medical education and operational support teams over the past two years to allow it to directly commercialize both BYFAVO and BARHEMSYS in the US through its own sales channels. The Company's experienced commercial team is focused on addressing the combined large market opportunities for procedural sedation and prevention and treatment of post-operative nausea & vomiting (PONV), which BYFAVO and BARHEMSYS target, respectively, that exist in the US hospital market. The initial focus of the commercial team over the first year of launch is to ensure that BYFAVO is listed on hospital formularies, based on the unmet needs it can address and the health economic benefits it can deliver.

'We are delighted to make BYFAVO available to anesthesia providers and to the millions of patients across the US who require moderate sedation to undergo medical procedures each year,' commented Mike Bolinder, Acacia Pharma's CEO. 'BYFAVO and BARHEMSYS have a clear and shared value proposition focused on safely and rapidly mobilizing patients after such procedures, which drives revenues of hospitals and surgical centers in the US. The launches come at a time when Covid-19 has had a significant impact on such centers, creating significant patient backlogs and impacting ongoing revenues. We believe our products can help improve patient throughput, which is now even more relevant for healthcare providers and their patients. We believe that the ability to help address the current backlog of elective surgeries, together with ongoing shortages for existing drugs in these therapeutic areas, puts Acacia Pharma in a strong position as the Company enters these markets.'

Mr. Bolinder added: 'It is a tremendous achievement for our company to gain approval and launch two new products in the US within the course of the last year. I would like to thank our partners at PAION as well as the Acacia Pharma team and our stakeholders who have enabled us to bring this new and innovative therapeutic to market, particularly given the challenges caused by the pandemic over the past year.'

Dr. Jim Phillips, Chief Executive Officer of PAION AG, stated: 'We are excited to support Acacia in their commercialization process, and we are delighted by the strong commitment to BYFAVO by our US partner Acacia. As sales build through the next months and years PAION will be receiving royalties of between 20-25% in the US. We look forward to a successful launch of what is a unique new product entering the market.'

BYFAVO is now available for ordering in the US through the major wholesalers and selected specialty distributors, including Cardinal Health, Amerisource Bergen, Besse, McKesson, McKesson Medsurg, Morris and Dickson, and Curascript.

Contact:

Mike Bolinder

Tel: +44 1223 919760

Email: IR@acaciapharma.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 marketed 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 centered in Cambridge, UK. The Company is listed on the Euronext Brussels exchange under the ISIN code GB00BYWF9Y76 and ticker symbol ACPH.

About BYFAVO

BYFAVO (remimazolam) for injection is a very rapid onset/offset intravenous benzodiazepine sedative for use during invasive medical procedures in adult patients lasting 30 minutes or less, such as during colonoscopy and bronchoscopy. Approximately 25 million such procedures take place annually in the US, of which around 90% use moderate sedation.

Cosmo in-licensed the US rights to BYFAVO from Paion AG in 2016 and together they have progressed the product candidate through to registration. BYFAVO is now approved and launched in the US and is indicated for the induction and maintenance of procedural sedation in adults lasting 30 minutes or less.

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.

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