It is estimated that about 5% to 20% of Americans suffer from influenza annually, and there are approximately 3,000 to 49,000 flu-related deaths per year in the U.S. The approved antivirals in the treatment of influenza are available only in oral or inhaled formulations and there are no approved injectable antivirals as yet in the U.S.
But what if the influenza patient is unconscious, making oral or inhaled drug administration difficult? Working to address this unmet need is biotechnology company BioCryst Pharmaceuticals Inc. (BCRX) with its investigational anti-viral agent Peramivir.
After the Southern Hemisphere wraps up its flu season this year, BioCryst will be providing an update on Peramivir, its intravenously administered investigational anti-viral agent against influenza A and B viruses, which is currently under phase III testing.
In the ongoing phase III study, the efficacy and safety of Peramivir administered intravenously in addition to the standard of care - Tamiflu, is compared against Tamiflu alone in adults and adolescents who are hospitalized due to serious influenza. The study was initiated in November 2009 and is currently recruiting participants.
BioCryst plans to conduct a planned interim analysis of the phase III Peramivir trial during the fourth quarter of 2012 following the Southern Hemisphere flu season.
Peramivir currently is being developed under a $234.8 million contract from the Biomedical Advanced Research and Development Authority (BARDA) within the United States Department of Health and Human Services (HHS). The company has a collaborative agreement with Shionogi & Co. Ltd. for Peramivir in Japan, and with Green Cross Corp. in Korea.
Peramivir is approved in Japan under the brand name Rapiacta and in South Korea under the name Peramiflu.
Another late-stage development program of Biocryst is Ulodesine for the treatment of gout. In phase III trials, Ulodesine is expected to be evaluated as add-on treatment to the approved xanthine oxidase, or "XO" inhibitors, Allopurinol or Febuxostat, in gout patients who are not adequately responding to a XO inhibitor alone.
In July of this year, the company reported positive results from two Ulodesine phase II trials in patients with gout. A Scientific Advice Process with the European Medicines Agency related to Ulodesine is underway, and feedback is expected this quarter (3Q, 2012), according to Biocryst.
Also in the company's pipeline are BCX5191 for hepatitis C and BCX4161 for hereditary angioedema, which remain on track to enter first-in-human trials before the end of this year.
A quick look at the company's balance sheet...
Since inception in 1986, the company has not achieved profitability. In the second quarter ended June 30, 2012, net loss narrowed to $12.3 million or $0.25 per share from $16.3 million or $0.36 per share in the year-ago quarter.
The company recognizes revenues from collaborative and other research and development arrangements and product sales. In the second quarter of 2012, revenues increased to $4.2 million from $3.7 million in last year's quarter as a result of an increase in collaboration revenue under the BARDA/HHS contract for Peramivir.
BioCryst was trading around $2.80 when it was profiled on our site last September. The stock has thus far hit a 52-week low of $2.28 and a 52-week high of $5.95. BCRX closed Thursday's trading at $4.29, up 3.37%.
What To Look For In BioCryst
by RTT Staff Writer
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