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DGAP-News: PAION AG / Key word(s): Miscellaneous
PAION ANNOUNCES APPROVAL OF COMPASSIONATE USE PROGRAM FOR REMIMAZOLAM IN BELGIUM
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. Under the program, remimazolam can be used for sedation of intensive care unit (ICU) patients with COVID-19, and as a substitute for current standard of care in general anesthesia for which there are currently shortages due to the coronavirus pandemic. The use is limited to physicians who have experience with remimazolam.
PAION was contacted by the Belgian regulatory authority as to whether remimazolam could be delivered nationwide because of the current shortages of propofol and midazolam due to the coronavirus pandemic. PAION will fulfill requests from hospitals as quickly and as much as possible and will deliver the material initially free of charge.
Dr. Jim Phillips, Chief Executive Officer of PAION AG, stated: "In the current exceptional situation triggered by the coronavirus pandemic, we are pleased to be able to do our part in enabling patients to get the treatment they need. Remimazolam has shown in numerous clinical trials that it could potentially be a safe and effective alternative to the currently used anesthetics, and we look forward to providing this drug to physicians and patients under this compassionate use program."
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 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).
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|EQS News ID:||1108253|
|End of News||DGAP News Service|