Orion Corporation and Phyxius Pharma have entered into a licensing agreement for levosimendan injection. According to the agreement Phyxius Pharma will develop and commercialize levosimendan in the USA and Canada for a new cardiovascular indication, prevention of Low Cardiac Output Syndrome (LCOS) in cardiac surgery patients.
LCOS is a common complication in patients undergoing cardiac surgery and there is no drug currently approved for the prevention or treatment of LCOS. Morbidity and mortality of LCOS patients is considerable and the relating cost burden is significant to the payors. Levosimendan has been granted a Fast Track status by FDA and the phase III clinical trial protocol has been approved through the FDA’s Special Protocol Assesment (SPA).
In order to facilitate the development of levosimendan Phyxius has yesterday signed a definitive agreement with a NASDAQ listed company Oxygen Biotherapeutics. Accoring to the terms of the agreement Oxygen Biotherapeutics will acquire exclusive rights to develop and commercialize levosimendan in USA and Canada as well as integrating three key Phyxius executives into the company’s management team. The initiation of the phase III trial is subject to funding raised by Oxygen Biotherapeutics.
Orion will manufacture levosimendan product for the US and Canadian markets. Phyxius will pay to Orion undisclosed development and commercial milestone payments, as well as, royalty based on the sales in the territory.