DGAP-Ad-hoc: PAION AG / Key word(s): Regulatory Approval
PAION AG: HANA PHARM RECEIVES MARKET APPROVAL FOR REMIMAZOLAM (BYFAVOTM) IN GENERAL ANESTHESIA IN SOUTH KOREA
Aachen (Germany), 07 January 2021 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) announces that Hana Pharm, remimazolam licensee for South Korea, today informed PAION that South Korea's Ministry of Food and Drug Safety (MFDS) has approved the New Drug Application (NDA) for BYFAVOTM (remimazolam) in general anesthesia.
The NDA approval of BYFAVOTM in South Korea triggers a milestone payment of EUR 1 million from Hana Pharm.
End of inside information
Information and Explanation of the Issuer to this News:
'With the next marketing approval the year 2021 gets off to a promising start for PAION, and we congratulate Hana Pharm on this achievement,' said Dr. Jim Phillips, CEO of PAION AG. 'With the recently started construction of their own production plant for BYFAVOTM, our partner continues to invest in the success of BYFAVOTM and we are looking forward to the upcoming market launch.'
Dr. Younha Lee, CEO of Hana Pharm, announced: 'We are thrilled to announce BYFAVOTM approval in South Korea and sincerely thankful for the rewarding partnership with PAION since 2013. Today's approval allows us to leverage Hana Pharm's significant development and commercialization expertise in anesthesiology in South Korea. We will be accelerating the remaining process towards product launch in South Korea and also the regulatory and commercial partnering progress in Singapore, Thailand, Vietnam, Indonesia, the Philippines and Malaysia this year.'
PAION granted Hana Pharm the exclusive rights to develop and commercialize BYFAVOTM for the South Korean market in 2013. Under the terms of the agreement, PAION is entitled to receive 10% royalties on Hana Pharm's remimazolam revenues in South Korea.
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. 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.
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).
07-Jan-2021 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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|EQS News ID:||1158290|
|End of Announcement||DGAP News Service|
1158290 07-Jan-2021 CET/CEST