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Acacia Pharma announces BYFAVO™ (remimazolam), its Newly Approved

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Leff0815   Tuesday, 10/06/20 02:43:23 PM
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Acacia Pharma announces BYFAVO™ (remimazolam), its Newly Approved Product for Procedural Sedation, Clears Final Hurdle on Path to Commercial Launch in the US

·BYFAVO expected to be commercially available in the US before the end of the year

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 – 6 October 2020: 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 chemotherapy, today announced that the US Drug Enforcement Administration (DEA) has designated its procedural sedative BYFAVO™ (remimazolam injection) as a Schedule IV medicine. This designation is the schedule for drugs with a low potential for abuse and low risk of dependence and is consistent with that granted to many other benzodiazepine drugs, including midazolam and diazepam (Valium®).

BYFAVO received approval from 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. Scheduling by DEA represents the final requirement for BYFAVO to be marketed in the US, with launch expected by the end of 2020.

“We are grateful to DEA for its timely determination of the scheduling of BYFAVO and are excited to bring this novel product to the US market,” commented Mike Bolinder, Acacia Pharma’s CEO. “We will start the process of labeling and packaging our stock of commercial product immediately so that we can make BYFAVO available to patients as soon as possible. We anticipate the product being available for sale in the US prior to the end of the year. Our first product, BARHEMSYS® (amisulpride injection) for postoperative nausea & vomiting, was launched in August and we are already registering product sales. We are delighted to be able to provide these two medicines to physicians and their patients in the United States.”

Acacia Pharma Group plc
Mike Bolinder, CEO
Gary Gemignani, CFO
+44 1223 919760 / +1 317 505 1280

International Media
Mark Swallow, Frazer Hall, David Dible
Citigate Dewe Rogerson
+44 20 7638 9571
US Investors
LifeSci Advisors
Irina Koffler
+1 917-734-7387
ikoffler@lifesciadvisors.com Media in Belgium and the Netherlands
Chris Van Raemdonck
+32 499 58 55 31

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 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.



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 in the US and is indicated for the induction and maintenance of procedural sedation in adults lasting 30 minutes or less.

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