@ Oxygen Biotherapeutics Closes the Acquisition of Phyxius Pharma Assets Related to Levosimenda | SEBIO

Oxygen Biotherapeutics Closes the Acquisition of Phyxius Pharma Assets Related to Levosimenda

Posted by on Nov 15, 2013

MORRISVILLE, N.C. – Oxygen Biotherapeutics, Inc. a developer of oxygen-carrying therapeutics, today announced the closing of its acquisition of certain assets of Phyxius Pharma, a privately-held biopharmaceutical company focused on the development and near-term commercialization of levosimendan to prevent and treat cardiac surgery patients at risk for developing low cardiac output syndrome (LCOS), a significant unmet medical need. Pursuant to the previously announced Purchase Agreement, Oxygen Biotherapeutics acquired the exclusive rights to develop and commercialize levosimendan in North America, and will welcome three key Phyxius Pharma executives into its management team.

“John Kelley is ideally suited to lead the Company and our transformation into an advanced clinical stage pharmaceutical company. I look forward to working closely with John Kelley, Doug Randall and Douglas Hay as we continue to grow Oxygen Biotherapeutics.”

At closing, John Kelley, Phyxius Pharma’s Co-Founder and CEO, was named CEO of Oxygen Biotherapeutics. Mr. Kelley will also be appointed to Oxygen Biotherapeutics’ Board of Directors at the next regularly scheduled meeting of the Board of Directors of the Company. Michael Jebsen, Oxygen Biotherapeutics’ prior interim CEO and current CFO, will continue serving as Oxygen Biotherapeutics’ CFO. In addition, two other former key Phyxius Pharma executives and co-founders are joining Oxygen Biotherapeutics. Doug Randall will serve as EVP of Business and Commercial Operations, and Douglas Hay, PhD, will serve as Oxygen Biotherapeutics’ EVP of Regulatory Affairs. Following stockholder approval of the transaction, one additional director designated by Phyxius Pharma stockholders will be appointed to Oxygen Biotherapeutics’ Board of Directors.

Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. acted as a financial advisor for the transaction.

“This acquisition represents the culmination of our efforts over the past two years. The second cohort of our Phase IIB clinical trial for traumatic brain injury is now well underway and we believe we are on the cusp of completing the additional preclinical studies undertaken to address the FDA’s concerns regarding perfluorocarbon -based products such as Oxycyte®. The Company is now ready to expand its product portfolio to renew the potential and value of Oxygen Biotherapeutics” stated Oxygen Biotherapeutics CFO Michael Jebsen. “John Kelley is ideally suited to lead the Company and our transformation into an advanced clinical stage pharmaceutical company. I look forward to working closely with John Kelley, Doug Randall and Douglas Hay as we continue to grow Oxygen Biotherapeutics.”

John Kelley, Oxygen Biotherapeutics’ new CEO commented, “My team and I at Phyxius have been working closely with our partners at Orion Pharma developing the protocol for this Phase 3 trial. Our study design was planned in close consultation with the FDA and with input from experienced levosimendan clinical researchers from across the world. The result of our significant planning is what we believe to be a highly efficient clinical trial that capitalizes on the learning of prior trials as well as the real world use of levosimendan in cardiac surgery patients. I look forward to testing our clinical hypothesis as we conduct our Phase 3 trial and I am pleased to be able to do so as part of the new Oxygen Biotherapeutics.”

Levosimendan was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland. Levosimendan is a calcium sensitizer developed for intra-venous use in hospitalized patients with acutely decompensated heart failure. It is currently approved in over 50 countries for this indication. It is not available in the United States. It is under development in North America for reduction in morbidity and mortality of cardiac surgery patients at risk of low cardiac output syndrome (LCOS). The acquisition brings to Oxygen Biotherapeutics not only the exclusive rights in North America to develop and commercialize levosimendan for the specific indication of prevention and treatment of LCOS, but also the FDA’s approval of Fast Track status for a Phase 3 trial, and the FDA’s SPA which represents agreement with the Phase III clinical trial’s study protocol. The FDA has provided guidance that a single successful trial will be sufficient to support approval of levosimendan in this indication.

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