Our vision is to be the accepted PAIONeer in sedation and anesthesia; helping advance patient care.
DGAP-News: PAION AG / Key word(s): Product Launch
PAION ANNOUNCES SUCCESSFUL PRODUCT LAUNCH OF ANEREM(R) (REMIMAZOLAM) IN JAPAN BY MUNDIPHARMA
Aachen (Germany), 07 August 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that Mundipharma, remimazolam licensee for Japan, informed PAION about the successful launch with first commercial product sales of Anerem(R) (remimazolam) for the use in general anesthesia in Japan.
Remimazolam was approved in Japan for general anesthesia in January 2020 and will be marketed under the brand name Anerem(R).
Dr. Jim Phillips, Chief Executive Officer of PAION AG, stated: "We are very pleased to hear that after the recent launch in Japan our partner has now made their first commercial sales, and product listing in multiple University & General Hospitals. PAION is eligible to royalties between 16-18% in Japan. This news is the first demonstration of a positive market response to the launch of remimazolam, and we look forward to sharing further commercial news when we receive it regarding the Japanese market."
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 received market approval in procedural sedation in July 2020. 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 topline data 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 (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 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. The topline data 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).
|Listed:||Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange|
|EQS News ID:||1111803|
|End of News||DGAP News Service|