Orion Corporation PRESS RELEASE 22 October 2013 at 9:00 a.m. EEST
Orion Corporation and Phyxius Pharma, Inc. 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, Inc. (NASDAQ: OXBT). 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.
About Simdax® and levosimendan
Simdax® (levosimendan) is Orion's proprietary drug for the treatment of acutely decompensated heart failure launched in 2000 and sold in more than 50 countries through Orion Corporation or its partners. Over 600 000 patients worldwide have been so far treated with levosimendan.
Simdax® is indicated for the short-term treatment of acutely decompensated severe chronic heart failure in situations where conventional therapy is not sufficient, and in cases where inotropic support is considered appropriate. Due to its unique cardioprotective inodilator properties Simdax® has shown promising results also in several cardiac surgery studies.
Read more about Oxygen Biotherapeutics, Inc.:
Dr. Liisa Hurme, Senior Vice President, Proprietary Products, Orion Corporation
tel. +358 50 966 2874
Orionintie 1A, FI-02200 Espoo, Finland
Orion is a globally operating Finnish company developing pharmaceuticals and diagnostic tests - a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients and diagnostic tests. The company is continuously developing new drugs and treatment methods. Pharmaceutical R&D focuses on central nervous system drugs, oncology and critical care drugs, and Easyhaler® pulmonary drugs.
Orion's net sales in 2012 amounted to EUR 980 million and the Company had about 3,500 employees. Orion's A and B shares are listed on NASDAQ OMX Helsinki.