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 COVID19. 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.
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About remimazolam
Remimazolam is an ultra-short-acting intravenous benzodiazepine
sedative/anesthetic. In the human body, remimazolam is rapidly metabolized
to an inactive metabolite by tissue esterases and is not metabolized by
cytochrome-dependent hepatic pathways. Like other benzodiazepines,
remimazolam can be reversed with flumazenil to rapidly terminate sedation or
anesthesia if necessary. In clinical studies, remimazolam demonstrated
efficacy and safety in around 2,900 volunteers and patients. Data so far
indicate that remimazolam has a rapid onset and offset of action combined
with a favorable cardio-respiratory safety profile.
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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
(R-Pharm) as well as South Korea and Southeast Asia (Hana Pharm). For all
other markets including parts of the EU, remimazolam is available for
licensing.
About PAION
PAION AG is a publicly listed specialty pharmaceutical company developing
and aiming to commercialize innovative drugs for out-patient and hospitalbased sedation, anesthesia and critical care services. PAION’s lead
compound is remimazolam, an intravenous, ultra-short-acting and controllable
benzodiazepine sedative/anesthetic. Remimazolam is partnered in multiple
territories outside of Europe. In Japan, remimazolam was approved for
general anesthesia in January 2020. In the U.S., a New Drug Application
(NDA) for procedural sedation is under review, with a PDUFA date of
05 July 2020. In China, licensee Yichang Humanwell filed for market approval
for remimazolam 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. 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)