Acacia Pharma Launches BYFAVO™ (remimazolam) in the United States for Procedural Sedation in Adults Undergoing Medical Procedures Lasting
30 Minutes or Less
Approximately 40 million procedures take place annually in the US that require the use of procedural sedation
BYFAVO is the second Acacia Pharma product approved and launched in the US in the last year and extends its portfolio of new products targeting unmet needs in anesthesia
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 – 28 January 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 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.