Remimazolam

EQS-News: PAION AG reports financial results for the first nine months of 2022

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Sunday, November 27, 2022
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In April 2022, PAION was informed that the Federal Joint Committee (G-BA) had approved PAION's application for eravacycline (XERAVA) as a reserve antibiotic.

Key Points: 
  • In April 2022, PAION was informed that the Federal Joint Committee (G-BA) had approved PAION's application for eravacycline (XERAVA) as a reserve antibiotic.
  • PAION is now exempt from providing a full benefit dossier and is only required to provide an abbreviated dossier by 1st August 2022.
  • Revenues increased to EUR 25.6 million in the first nine months of 2022 (same period last year: EUR 5.5 million).
  • Based on the results for the first nine months of 2022, PAION raises the outlook for the full year 2022 announced with the Annual Report 2021.

DGAP-News: PAION AG reports financial results for the first half-year 2022

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Wednesday, August 31, 2022
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PAION is now exempt from providing a full benefit dossier and is only required to provide an abbreviated dossier by 1st August 2022.

Key Points: 
  • PAION is now exempt from providing a full benefit dossier and is only required to provide an abbreviated dossier by 1st August 2022.
  • The sale of angiotensin II (GIAPREZA) was expanded from Germany to the Netherlands and Austria in early 2022.
  • In China, PAION entered into a patent assignment agreement with Humanwell at the beginning of 2022.
  • EUR 16 million were received in the first quarter of 2022, and the remaining EUR 4.5 million have been paid in June 2022.

DGAP-News: PAION LAUNCHES ERAVACYCLINE FOR THE TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS IN ADULTS IN GERMANY

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Monday, August 1, 2022
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In April 2022, the Federal Joint Committee (G-BA) voted in favour of PAIONs application for eravacycline as a reserve antibiotic.

Key Points: 
  • In April 2022, the Federal Joint Committee (G-BA) voted in favour of PAIONs application for eravacycline as a reserve antibiotic.
  • Eravacycline is approved by the European Commission and the UK Medicines Agency for the treatment of complicated intra-abdominal infections (cIAI) in adults.
  • Eravacycline is an important new treatment option for patients suffering from serious intra-abdominal infections.
  • Eravacycline is an antibiotic used to treat complicated intra-abdominal infections (cIAI) in adults.

DGAP-News: ​​​​​​​PAION AG: ANNUAL GENERAL MEETING APPROVES ALL AGENDA ITEMS AND ELECTS MICHAEL SCHLENK AND GREGOR SIEBERT TO THE SUPERVISORY BOARD

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Wednesday, May 25, 2022
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In addition, Michael Schlenk and Gregor Siebert were elected to the Supervisory Board, replacing Dr Dr Irina Antonijevic and Dr Jrg Spiekerktter.

Key Points: 
  • In addition, Michael Schlenk and Gregor Siebert were elected to the Supervisory Board, replacing Dr Dr Irina Antonijevic and Dr Jrg Spiekerktter.
  • Mr Schlenk will take over the chairmanship of the Supervisory Board from Dr Spiekerktter.
  • "We are delighted to have gained two recognised experts from the pharmaceutical industry as members of PAION AG's Supervisory Board.
  • Michael Schlenk, designated Chairman of the Supervisory Board of PAION AG, commented: "I am delighted about the election to the Supervisory Board by the Annual General Meeting.

DGAP-News: ​​​​​​​PAION AG PUBLISHES GROUP QUARTERLY STATEMENT FOR THE FIRST QUARTER OF 2022

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Thursday, May 19, 2022
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Dr. Jim Phillips, CEO of PAION AG, commented: "The first quarter of 2022 has brought further progress in our transformation into a specialty pharma company.

Key Points: 
  • Dr. Jim Phillips, CEO of PAION AG, commented: "The first quarter of 2022 has brought further progress in our transformation into a specialty pharma company.
  • In April 2022, PAION was informed that the Federal Joint Committee (G-BA) voted in favor of PAIONs application for eravacycline (XERAVA) as a reserve antibiotic.
  • Licensees generated remimazolam revenues totalling EUR 0.9 million in the first quarter of 2022, amounting to royalties for PAION of EUR 0.1 million.
  • PAION confirms its outlook for the current fiscal year given in March 2022 with the publication of the 2021 consolidated financial statements and group management report.

DGAP-News: PAION AG ANNOUNCES CHANGE IN MANAGEMENT BOARD

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Friday, April 1, 2022
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Aachen (Germany), 30 March 2022 - The specialty pharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today announces that Sebastian Werner has been appointed by the Supervisory Board as a new member of the Management Board in the position as Chief Financial Officer ("CFO") of PAION AG with effect from 1 June 2022.

Key Points: 
  • Aachen (Germany), 30 March 2022 - The specialty pharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today announces that Sebastian Werner has been appointed by the Supervisory Board as a new member of the Management Board in the position as Chief Financial Officer ("CFO") of PAION AG with effect from 1 June 2022.
  • "With his many years of international expertise in the pharmaceutical industry, Sebastian Werner is an excellent addition to the Management Board of PAION AG.
  • I wish him every success in his new role," said Dr. Jrg Spiekerktter, Chairman of the Supervisory Board of PAION AG.
  • "My special and sincere thanks also go to Mr. Omari for his successful work and great commitment to PAION over the past 14 years," commented Dr. Jrg Spiekerktter, Chairman of the Supervisory Board of PAION AG.

DGAP-News: PAION AG ANNOUNCES CHANGE IN SUPERVISORY BOARD

Retrieved on: 
Thursday, January 27, 2022
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Michael Schlenk to succeed Dr. Dr. Irina Antonijevic and to become candidate for the chairmanship of the Supervisory Board

Key Points: 
  • Michael Schlenk to succeed Dr. Dr. Irina Antonijevic and to become candidate for the chairmanship of the Supervisory Board
    Aachen (Germany), 27 January 2022 - The specialty pharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today announces that the Supervisory Board and the Management Board of PAION AG have unanimously proposed the appointment of Michael Schlenk as member of the Supervisory Board to the district court of Aachen.
  • The long-standing Chairman of the Supervisory Board, Dr. Jrg Spiekerktter, will retire from the Supervisory Board at the next Annual General Meeting in May 2022 after 15 years with expiry of his mandate.
  • "We are pleased to welcome Michael Schlenk, a recognized expert in the life science industry, as a candidate of the Supervisory Board," said Dr. Jrg Spiekerktter, Chairman of the Supervisory Board of PAION AG.
  • PAION AG is a publicly listed specialty pharmaceutical company with innovative drugs to be used in hospital-based sedation, anesthesia and critical care services.

DGAP-News: PAION SUBMITS EXTENSION APPLICATION OF MARKETING AUTHORIZATION FOR REMIMAZOLAM IN THE INDICATION GENERAL ANESTHESIA TO THE EUROPEAN MEDICINES AGENCY

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Friday, December 31, 2021
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Aachen (Germany), 31December 2021 - The Specialty Pharma Company PAION AG (FSE: PA8) today announces that PAION has submitted an extension application to the Marketing Authorization for remimazolam (Byfavo(R)), PAION's ultra-short-acting intravenous benzodiazepine sedative/anesthetic, for the indication general anesthesia to the European Medicines Agency (EMA).

Key Points: 
  • Aachen (Germany), 31December 2021 - The Specialty Pharma Company PAION AG (FSE: PA8) today announces that PAION has submitted an extension application to the Marketing Authorization for remimazolam (Byfavo(R)), PAION's ultra-short-acting intravenous benzodiazepine sedative/anesthetic, for the indication general anesthesia to the European Medicines Agency (EMA).
  • The European Commission approved remimazolam in the EU (including European Economic Area (EEA) countries) for procedural sedation in March 2021.
  • Based on the positive results in the EU Phase III trial in general anesthesia, PAION has now submitted an extension application to the marketing authorization for remimazolam in the indication of general anesthesia.
  • Remimazolam is approved in the U.S., the EU/EEA/UK, China and South Korea for procedural sedation and in Japan and South Korea for general anesthesia.

DGAP-News: PAION AG ANNOUNCES INITIATION OF PIVOTAL STUDY OF REMIMAZOLAM (BYFAVO(R)) IN PEDIATRIC PROCEDURAL SEDATION

Retrieved on: 
Thursday, September 16, 2021
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We are excited to be working with an outstanding group of pediatric sedation experts on this important initiative."

Key Points: 
  • We are excited to be working with an outstanding group of pediatric sedation experts on this important initiative."
  • However, PAION and Acacia have elected to accelerate the conduct of the study significantly because of the important unmet medical need for remimazolam in pediatric procedural sedation.
  • PAION AG is a publicly listed specialty pharmaceutical with innovative drugs to be used in hospital-based sedation, anesthesia and critical care services.
  • Remimazolam is approved in the U.S., the EU/EEA/UK, China and South Korea for procedural sedation and in Japan and South Korea for general anesthesia.

DGAP-News: PAION SIGNS EXCLUSIVE UK SUPPLY AND DISTRIBUTION AGREEMENT WITH CLINIGEN

Retrieved on: 
Thursday, September 2, 2021
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Aachen (Germany), 02 September 2021 - The Specialty Pharma Company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard) today announces that PAION has signed an exclusive partnership agreement with Clinigen for the supply and distribution of its products into the UK.

Key Points: 
  • Aachen (Germany), 02 September 2021 - The Specialty Pharma Company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard) today announces that PAION has signed an exclusive partnership agreement with Clinigen for the supply and distribution of its products into the UK.
  • In addition, PAION has two further products, GIAPREZA(R) (angiotensin II) and XERAVA(R) (eravacycline), in its portfolio that have also been launched recently outside the UK.
  • Under the terms of the agreement Clinigen will manage the supply and distribution of PAION's licensed products in the UK.
  • Katja Lundell, Country Manager UK of PAION UK Ltd, commented: "We are delighted to partner with Clinigen for the commercial launch of Byfavo(R), leveraging their strong regulatory, supply and distribution capabilities to ensure broad access of this important product in the UK.