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DGAP-News: PAION AG / Key word(s): Miscellaneous
PAION ANNOUNCES APPROVAL OF COMPASSIONATE USE FOR REMIMAZOLAM IN ITALIAN HOSPITAL
Aachen (Germany), 02 June 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that the local Ethics Commitee of the Hospital San Raffaele in Milan/Italy has granted approval for the compassionate use of remimazolam for the use of sedation of five intensive care unit (ICU) patients with COVID-19. After that inital use the treatment might be extended to a wider number of patients at the hospital.
PAION was contacted by the San Raffaele Hospital as to whether remimazolam could be delivered since a shortage of propofol and midazolam due to the coronavirus pandemic occurred. PAION will fulfill the request from the hospital and will deliver the material free of charge.
Dr. Phillips (CEO of PAION AG) commented: "We are pleased to be able to help San Raffaele during the current Covid-19 crisis, and to be able to contribute to the global fight against the pandemic."
Compassionate use is allowed under EU law under strict conditions and refers to the use of medicines that are expected to help patients with life-threatening, long-lasting or seriously disabling illnesses but that are not yet authorized or licensed. 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 clinical studies, remimazolam demonstrated efficacy and safety in approximately 2,900 volunteers and patients. Remimazolam has received marketing authorization in Japan, and marketing approval applications have been submitted inter alia in the U.S. and in Europe.
In Japan, licensee Mundipharma received market approval in general anesthesia in January 2020. In the U.S., licensee Cosmo Pharmaceuticals submitted a New Drug Application for procedural sedation in April 2019, with a PDUFA decision date of 05 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. (Cosmo Pharmaceuticals, sublicensed to Acacia Pharma), Japan (Mundipharma), China (Yichang Humanwell), Canada (Pharmascience), Russia/CIS, Turkey and the MENA region
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 & critical care by bringing novel products to market to benefit patients, doctors & stakeholders in healthcare.
PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).
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|EQS News ID:||1058021|
|End of News||DGAP News Service|