Paion (PA8) - US and Japan filings and EU Phase III on track

04:41 EST 10 Nov 2017 | Edison Investment Research

Edison Investment Research - Pharmaceutical & healthcare - Paion: Paion remains on track to file for approval of Remimazolam in 2018 for procedural sedation (via partner Cosmo Pharmaceuticals in the US) and general anaesthesia (GA) in Japan. Remimazolam’s excellent safety profile and shorter procedure times than midazolam are expected to drive uptake if it gains market approval. Preparations are underway for an EU Phase III study for GA in general surgery patients to start in 2018 (subject to funding). Recently granted formulation and dosing patents will strengthen market exclusivity in the EU and Japan until 2033, which sees us lift our valuation to €260m (vs €245m) or €4.25/share.
ISIN: DE000A0B65S3

Original Article: Paion (PA8) - US and Japan filings and EU Phase III on track


More From BioPortfolio on "Paion (PA8) - US and Japan filings and EU Phase III on track"

Quick Search


Relevant Topics

Health care (or healthcare) is the diagnosis, treatment, and prevention of disease, illness, injury, and other physical and mental impairments in humans. Health care is delivered by practitioners in medicine, chiropractic, dentistry, nursing, pharmacy, a...

Collaborations in biotechnology
Commercial and academic collaborations are used throughout the biotechnology and pharmaceutical sector to enhance research and product development. Collaborations can take the form of research and evaluation agreements, licensing, partnerships etc. ...

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...