PAION ANNOUNCES U.S. FDA APPROVAL OF REMIMAZOLAM (BYFAVO) FOR THE INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION
PAION AG / Key word(s): Regulatory Approval
PAION ANNOUNCES U.S. FDA APPROVAL OF REMIMAZOLAM (BYFAVOTM) FOR THE INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION
- PAION will receive a milestone payment of EUR 15 million from Cosmo and tiered royalties on net sales ranging from 20% to 25%
- Acacia, who will commercialize BYFAVOTM (remimazolam) in the U.S., is planning to launch in the second half of 2020
PAION has developed BYFAVOTM including the conduct of three Phase III clinical studies and granted Cosmo Pharmaceuticals NV (Cosmo) exclusive rights to develop and commercialize BYFAVOTM for the U.S. market in 2016. In January 2020, Acacia Pharma sub-licensed the commercial rights to BYFAVO in the U.S. from Cosmo.
Under the terms of the agreement with Cosmo, PAION will receive a milestone payment of EUR 15 million from Cosmo and is entitled to tiered royalties on net sales in the U.S. ranging from 20% to 25%, which may be adjusted under certain conditions but cannot fall below 15% of net sales.
End of inside information
Information and Explanation of the Issuer to this News:
The safety of BYFAVOTM was evaluated in three pivotal studies in 669 patients undergoing colonoscopy (two studies) or bronchoscopy (one study), of whom 630 received BYFAVOTM. In these studies, the most common adverse reactions (incidence greater than 10%) following BYFAVOTM administration were hypotension, hypertension, diastolic hypertension, systolic hypertension, hypoxia, and diastolic hypotension. The labeling for BYFAVOTM includes a Boxed Warning regarding appropriate training of personnel and equipment that must be available when administering BYFAVOTM, during sedation and during the recovery period of the procedure. The Boxed Warning also addresses risks from concomitant use of BYFAVOTM with opioid analgesics and other sedative hypnotics.
Acacia Pharma's first product, BARHEMSYS(R) (amisulpride injection), was approved by the FDA on 26 February 2020 for the treatment and prevention of postoperative nausea and vomiting (PONV) in adult patients and the company intends to launch both BARHEMSYS(R) and BYFAVOTM in the U.S. during the second half of 2020.
In Japan, licensee Mundipharma received market approval in general anesthesia in January 2020. In the U.S., licensee Cosmo Pharmaceuticals received market approval in procedural sedation in July 2020. In China, licensee Yichang Humanwell filed for market approval in procedural sedation in November 2018. In South Korea, licensee Hana Pharm filed for market approval in general anesthesia in December 2019. In Europe, PAION submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in procedural sedation in November 2019 and results of an EU Phase III trial in general anesthesia are expected in the second half of 2020.
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 Cosmo Pharmaceuticals, sublicensed to Acacia Pharma, in Japan (brand name Anerem(R)) with Mundipharma, in China with Yichang Humanwell, in Canada with Pharmascience, in Russia/CIS, Turkey and the MENA region with R-Pharm, and in South Korea and Southeast Asia with Hana Pharm. For all other markets including parts of the EU, remimazolam is available for licensing.
In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation. PAION submitted a Marketing Authorization Application (MAA) for procedural sedation in November 2019. Results of a Phase III trial in general anesthesia are expected in the second half of 2020.
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 & other stakeholders in healthcare.
PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).
02-Jul-2020 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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