How Levosimendan’s Progress could make or break the Phyxius Pharma/Oxygen Biotherapeutics Deal
Mumbai, India -- (SBWIRE) -- 12/02/2013 -- Morrisville, North Carolina-headquartered Oxygen Biotherapeutics, Inc. has seen its stock touch new highs over the last month, with a peak appearing right at the end of October. These highs appear to be relatively stable this November with no major downward spikes occurring.
The positive trend in OXBT’s stock began with news from Phyxius Pharma, Inc., the biopharm company Oxygen Biotherapeutics had agreed to acquire certain assets from in October, related to results of a meta-analysis study for levosimendan.
Phyxius Pharma and Oxygen Biotherapeutics jointly announced on October the 30th that findings from a meta-analysis of multiple clinical trials for use of levosimendan in patients undergoing heart surgery showed that levosimendan was associated with reduced mortality and other adverse outcomes including heart attacks during and after operation in patients with reduced heart function undergoing heart surgery. The findings were published by the Duke Clinical Research Institute (DCRI), involving 1155 patients from 14 independent clinical trials. John Alexander, the Director of Cardiovascular Research at the DCRI, even went on to put a number to the findings, saying that their analysis suggested that levosimendan, in conjunction with standard care in high-risk cardiac surgery patients with reduced left ventricular function could reduce mortality and other adverse outcomes by as much as 50%.
Levosimendan, currently approved in 53 countries for treating hospitalized patients with acutely decompensated heart failure, still awaits U.S. FDA approval. It was originally discovered and developed by Orion Pharma of Finland.
The FDA had guided that a single successful trial would be sufficient to support approval of levosimendan for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome. In addition, the FDA had also granted Fast Track status to Phyxius Pharma for levosimendan for the above indication.
In a major move aimed at fully capitalizing on the potential of levosimendan, Oxygen Biotherapeutics announced on November 14th that it had closed on its October 21st agreement to acquire exclusive rights from Phyxius Pharma to develop and commercialize levosimendan in North America. With levosimendan already obtaining a Fast Track status for a Phase 3 trial from the FDA, Oxygen Biotherapeutics could look forward to a quicker FDA approval, if it comes through.
The deal with Phyxius Pharma was valued at approximately $4.8 million in stock as of October 18, 2013. John Kelley, Phyxius Pharma’s Co-Founder would head Oxygen Biotherapeutics as its new CEO, on closing of the transaction. Speaking on the deal, Oxygen’s Interim CEO and CFO Michael Jebsen noted that levosimendan placed them on a clear path to commercialization and an opportunity to address a $600 million market.
Investor attention would now be focused on how Oxygen goes ahead with further trials for levosimendan and when they approach the FDA. Going by the trend shown over the last 30 days, OXBT appears be a definite hold till that time.
Earnings Impact Launches Ideaz
Ideaz are a collection of articles on currently trending stocks and topics which are making headlines. Certain articles provide you a graphical perspective of reasons behind why a company or its product stays in the news.
About Analyz Thiz
Analyz Thiz helps you understand the correlation between the time when a company’s conference call transcript is available and the effect it has on its stock price at that point in time.
About Editor’s Picks
The latest feature on Earnings Impact is Editor's Picks, where a selection of game-changing transcripts are listed which explain why those companies are in the news.
About Earnings Impact
Earningsimpact.com is the destination for Transcripts of events that could impact stocks and its stakeholders. Transcripts are posted on earningsimpact.com within 2 hours of the live event. Active investors and traders will get access to this vital information much before the market reacts.
Copyright © 2005-2014 - SBWire, The Small Business Newswire - All Rights Reserved - Important Disclaimer
Contact Us: 888-4-SBWIRE (US) - 920-593-5640 (International)