U.S. LICENSE AGREEMENT FOR BYFAVOTM (REMIMAZOLAM) BETWEEN PAION AND COSMO ASSIGNED FROM COSMO TO ACACIA
DGAP-News: PAION AG
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Dr. Jim Phillips, CEO of PAION AG, commented: "We are very pleased that we have come to an agreement with Cosmo and Acacia, which will simplify what until now has been a three party relationship, and going forward we can interact directly with the Acacia team to support commercialisation. With the recent market approval of BYFAVOTM in the U.S., we are pleased to now be able to have a direct relationship with the end-commercialization partner. We want to thank Cosmo for their support in the past years and look forward to continuing to work with them as an investor and shareholder."
"We are very pleased to have been assigned the U.S. license to BYFAVOTM following its very recent approval by the U.S. Food and Drug Administration and are grateful for all the support provided by Cosmo," commented Mike Bolinder, Acacia Pharma's CEO. "This new direct arrangement with PAION will allow us to better collaborate and access their deep expertise on the benefits of BYFAVOTM as we look to begin the commercialization of this important new product for procedural sedation in adult patients, alongside BARHEMSYS(R), in the months ahead."
Alessandro Della Chà, CEO of Cosmo, said: "This assignment is important in order to let Acacia entertain a direct relationship with PAION. We look forward to continue to contribute to the success of BYFAVOTM as shareholders of both Acacia and PAION."
In Japan, licensee Mundipharma received market approval in general anesthesia in January 2020. In the U.S., former 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 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).
15.07.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
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