Remimazolam

DGAP-News: PAION REPORTS POSITIVE REMIMAZOLAM TOPLINE DATA IN EU PHASE III TRIAL IN GENERAL ANESTHESIA

Thursday, November 19, 2020 - 10:07pm

- Key secondary endpoint met: remimazolam demonstrated superior hemodynamic stability compared to propofol

Key Points: 
  • - Key secondary endpoint met: remimazolam demonstrated superior hemodynamic stability compared to propofol
    - EU Phase III program completed; data to serve as basis for MAA submission in general anesthesia
    Aachen (Germany), 19 November 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces positive topline data from the pivotal remimazolam EU Phase III trial in general anesthesia.
  • Assuming approval in procedural sedation, PAION plans to submit an extension of the marketing authorization for remimazolam for general anesthesia.
  • In addition to procedural sedation and general anesthesia, based on positive Phase II study results, ICU sedation is another possible indication for remimazolam.
  • In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation.

DGAP-News: PAION AG PUBLISHES GROUP QUARTERLY STATEMENT FOR THE FIRST NINE MONTHS OF 2020

Wednesday, November 11, 2020 - 7:01am

In the U.S., the FDA (Food & Drug Administration) granted market approval of BYFAVOTM (remimazolam) for procedural sedation in July 2020.

Key Points: 
  • In the U.S., the FDA (Food & Drug Administration) granted market approval of BYFAVOTM (remimazolam) for procedural sedation in July 2020.
  • In October 2020, the Drug Enforcement Administration (DEA) designated BYFAVO(TM) as a Schedule IV medicine, which was a prerequisite for launch.
  • The overall evaluation of opportunities and risks has not changed significantly in the first nine months of 2020.
  • PAION confirms its financial outlook for the current fiscal year announced on 12 August 2020 with the publication of the half-year results for 2020.

DGAP-News: PAION REPORTS PROGRESS WITH BYFAVO (REMIMAZOLAM) BY ITS LICENSEE ACACIA IN THE U.S.

Tuesday, October 6, 2020 - 5:05pm

PAION REPORTS PROGRESS WITH BYFAVO (REMIMAZOLAM) BY ITS LICENSEE ACACIA IN THE U.S.

Key Points: 
  • PAION REPORTS PROGRESS WITH BYFAVO (REMIMAZOLAM) BY ITS LICENSEE ACACIA IN THE U.S.
  • Scheduling by DEA represents the final requirement for BYFAVO(TM) to be marketed in the U.S., with launch expected by the end of 2020.
  • Our first product, BARHEMSYS(R) (amisulpride injection) for postoperative nausea & vomiting, was launched in August and we are already registering product sales.
  • The topline data of a Phase III trial in general anesthesia are expected in the second half of 2020.

DGAP-News: PAION AG REPORTS FINANCIAL RESULTS FOR THE FIRST HALF-YEAR 2020

Wednesday, August 12, 2020 - 7:01am

In the U.S., the FDA (U.S. Food & Drug Administration) granted market approval of BYFAVOTM (remimazolam) for procedural sedation in July 2020.

Key Points: 
  • In the U.S., the FDA (U.S. Food & Drug Administration) granted market approval of BYFAVOTM (remimazolam) for procedural sedation in July 2020.
  • In July 2020, after market approval of BYFAVOTM, PAION, Cosmo and Acacia agreed to assign the BYFAVOTM license agreement signed in 2016 between Cosmo and PAION to Acacia.
  • In Europe, PAION is seeking approval for remimazolam in procedural sedation and in general anesthesia.
  • Procedural sedation: PAION submitted a Marketing Authorization Application (MAA) for procedural sedation to the European Medicines Agency (EMA) in November 2019.

DGAP-News: PAION ANNOUNCES PROGRESS WITH REMIMAZOLAM BY ITS PARTNER YICHANG HUMANWELL IN CHINA

Tuesday, August 11, 2020 - 10:03am

Aachen (Germany), 11 August 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that its Chinese remimazolam licensee Yichang Humanwell has recently launched Ruima(R) (remimazolam) in procedural sedation in China.

Key Points: 
  • Aachen (Germany), 11 August 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that its Chinese remimazolam licensee Yichang Humanwell has recently launched Ruima(R) (remimazolam) in procedural sedation in China.
  • Remimazolam (brand name Ruima(R)) was approved in China for procedural sedation in July 2020.
  • We are delighted by the strong commitment to remimazolam by our Chinese partner Yichang Humanwell.
  • In China, licensee Yichang Humanwell received market approval in procedural sedation in July 2020.

DGAP-News: PAION ANNOUNCES SUCCESSFUL PRODUCT LAUNCH OF ANEREM (REMIMAZOLAM) IN JAPAN BY MUNDIPHARMA

Friday, August 7, 2020 - 7:00am

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.

Key Points: 
  • 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.
  • PAION is eligible to royalties between 16-18% in Japan.
  • In Japan, licensee Mundipharma received market approval in general anesthesia in January 2020.
  • The topline data of a Phase III trial in general anesthesia are expected in the second half of 2020.

DGAP-News: PAION ANNOUNCES APPROVAL OF COMPASSIONATE USE PROGRAM FOR REMIMAZOLAM IN BELGIUM

Monday, August 3, 2020 - 3:08pm

Aachen (Germany), 03 August 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that the Federal Agency for Medicines and Health Products in Belgium (FAMHP) has granted approval for the compassionate use of remimazolam, an ultra-short-acting benzodiazepine sedative/anesthetic.

Key Points: 
  • Aachen (Germany), 03 August 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that the Federal Agency for Medicines and Health Products in Belgium (FAMHP) has granted approval for the compassionate use of remimazolam, an ultra-short-acting benzodiazepine sedative/anesthetic.
  • PAION will fulfill requests from hospitals as quickly and as much as possible and will deliver the material initially free of charge.
  • Within a compassionate use program, medicines can be made available to patients if sufficient indication of the efficacy and safety of the medicinal product exists.
  • In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation.

DGAP-News: U.S. LICENSE AGREEMENT FOR BYFAVOTM (REMIMAZOLAM) BETWEEN PAION AND COSMO ASSIGNED FROM COSMO TO ACACIA

Wednesday, July 15, 2020 - 7:00am

Aachen (Germany), 15 July 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that PAION, U.S. remimazolam licensee Cosmo Pharmaceuticals NV ("Cosmo") and Acacia Pharma ("Acacia") have agreed to assign the BYFAVOTM (remimazolam) license agreement signed in 2016 between Cosmo and PAION to Acacia.

Key Points: 
  • Aachen (Germany), 15 July 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that PAION, U.S. remimazolam licensee Cosmo Pharmaceuticals NV ("Cosmo") and Acacia Pharma ("Acacia") have agreed to assign the BYFAVOTM (remimazolam) license agreement signed in 2016 between Cosmo and PAION to Acacia.
  • The terms of the license agreement remain unchanged but will now be between PAION and Acacia, with Cosmo no longer being a party to the agreement.
  • Alessandro Della Ch, 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."

DGAP-News: PAION REPORTS FULL CONVERSION OF CONVERTIBLE NOTES

Wednesday, July 8, 2020 - 6:07pm

Aachen (Germany), 08 July 2020 - The specialty pharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that the EUR 5 million convertible notes issued to Yorkville Advisors Global, LP (Yorkville) in September 2019 have been converted into a total of 2,363,350 PAION shares.

Key Points: 
  • Aachen (Germany), 08 July 2020 - The specialty pharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that the EUR 5 million convertible notes issued to Yorkville Advisors Global, LP (Yorkville) in September 2019 have been converted into a total of 2,363,350 PAION shares.
  • The convertible notes have thus been converted completely and a further use of the financing agreement with Yorkville is not planned.
  • Abdelghani Omari, CFO of PAION AG, commented: "We would like to thank Yorkville for their support over the last year.
  • In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation.

DGAP-News: PAION ANNOUNCES U.S. FDA APPROVAL OF REMIMAZOLAM (BYFAVOTM) FOR THE INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION

Thursday, July 2, 2020 - 8:01pm

"We are very pleased to announce today the approval of BYFAVOTM in the U.S. for procedural sedation in adult patients," commented Mike Bolinder, Acacia Pharma's CEO.

Key Points: 
  • "We are very pleased to announce today the approval of BYFAVOTM in the U.S. for procedural sedation in adult patients," commented Mike Bolinder, Acacia Pharma's CEO.
  • In addition to procedural sedation and general anesthesia, based on positive Phase II study results, ICU sedation is another possible indication for remimazolam.
  • In China, licensee Yichang Humanwell filed for market approval in procedural sedation in November 2018 and in South Korea, licensee Hana Pharm filed for market approval for remimazolam in general anesthesia in December 2019.
  • In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation.