DGAP-News: PAION AG
/ Key word(s): Product Launch
PAION AG: ACACIA PHARMA LAUNCHES BYFAVO(TM) (REMIMAZOLAM) IN THE U.S. FOR PROCEDURAL SEDATION IN ADULTS UNDERGOING MEDICAL PROCEDURES LASTING 30 MINUTES OR LESS
- Approximately 40 million procedures take place annually in the U.S. that require the use of procedural sedation
- BYFAVO(TM) is the second Acacia Pharma product approved and launched in the U.S. in the last year and extends its portfolio of new products targeting unmet needs in anesthesia
Aachen (Germany), 28 January 2021 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that its U.S. BYFAVO(TM) (remimazolam) licensee Acacia Pharma (Acacia) has informed PAION today that BYFAVO(TM) has been launched and is now commercially available in the U.S. for order and delivery to customers through major wholesalers and specialty distributors.
BYFAVO(TM) was approved by the U.S. 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 U.S. Drug Enforcement Administration (DEA) on 6 October 2020, finalizing the approval process and clearing the way for final packaging and shipping to the U.S.
Acacia has built critical sales, marketing, medical education and operational support teams over the past two years to allow it to directly commercialize both BYFAVO(TM) and BARHEMSYS(R) in the U.S. through its own sales channels. Acacia'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(TM) and BARHEMSYS(R) target, respectively, that exist in the U.S. hospital market. The initial focus of the commercial team over the first year of launch is to ensure that BYFAVO(TM) is listed on hospital formularies, based on the unmet needs it can address and the health economic benefits it can deliver.
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(TM) by our U.S. partner. As sales build through the next months and years PAION will be receiving royalties of between 20-25% in the U.S. We look forward to a successful launch of what is a unique new product entering the market."
Mike Bolinder, Acacia Pharma's CEO, commented: "We are delighted to make BYFAVO(TM) available to anesthesia providers and to the millions of patients across the U.S. who require moderate sedation to undergo medical procedures each year. BYFAVO(TM) and BARHEMSYS(R) 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 U.S. 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 U.S. within the course of the last year. I would like to thank PAION, our partners 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."
BYFAVO(TM) is now available for ordering in the U.S. through the major wholesalers and selected specialty distributors, including Cardinal Health, Amerisource Bergen, Besse, McKesson, McKesson Medsurg, Morris and Dickson, and Curascript.
Remimazolam is approved in the U.S. and China for procedural sedation and in Japan and South Korea for general anesthesia. In Europe, PAION submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in procedural sedation in November 2019.
In addition to procedural sedation and general anesthesia, based on positive Phase II study results, ICU sedation is another possible indication for remimazolam.
Remimazolam is partnered in the U.S. (brand name BYFAVOTM) with Acacia Pharma, in Japan (brand name Anerem(R)) with Mundipharma, in China (brand name Ruima(R)) with Yichang Humanwell, in Canada with Pharmascience, in Russia/CIS, Turkey and the MENA region with R-Pharm, and in South Korea (brand name BYFAVOTM) and Southeast Asia with Hana Pharm.
In Europe, PAION is seeking approval of Byfavo(R) (remimazolam) for general anesthesia and for procedural sedation. PAION submitted a Marketing Authorization Application (MAA) for procedural sedation in November 2019. It is planned to commercialize Byfavo(R) once approved in Europe together with GIAPREZA(TM) as a vasoconstrictor indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies, and XERAVA(TM) for the treatment of complicated intra-abdominal infections in adults.
PAION's mission is to be a leading specialty pharmaceutical company in the fields of anesthesia and critical care by bringing novel products to market to benefit patients, doctors and other stakeholders in healthcare.
PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).
28.01.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
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