Hemispherx Biopharma Europe N.V./S.A. Receives Positive Opinion on Application for Orphan Designation by the European Medicines Agency for Alferon N Injection to Treat Patients with Middle East Respiratory Syndrome (MERS)
…..Hemispherx’ Next Step in the Fight to Treat Patients with MERS
Philadelphia, PA, Monday, October 19, 2015: Hemispherx Biopharma, Inc. (NYSE MKT: HEB) (the “Company” or “Hemispherx”) announces that the European subsidiary, “Hemispherx Biopharma Europe N.V./S.A” gained a positive opinion from the COMP (Committee on Medical Products) regarding its Orphan Medicinal Product Application for Alferon N Injection® to treat Middle East Respiratory Syndrome (MERS).
The COMP is of the opinion that the medicinal product satisfies the criteria for designation and the sponsor has established that there exists no satisfactory method of treatment of MERS. The COMP, therefore, recommends the granting of orphan medicinal product designation for Alferon N Injection® in respect to the MERS indication.
Middle East Respiratory Syndrome (MERS) was first identified in Saudi Arabia in 2012, and is an illness caused by a coronavirus known as the Middle East Respiratory Syndrome Coronavirus (MERS-CoV). Infection can cause severe acute respiratory illness with symptoms of fever, cough, and shortness of breath as well as death. Some people infected developed pneumonia and experienced gastrointestinal symptoms including diarrhea, nausea/vomiting, and kidney failure. MERS has a fatality rate of 38% and the mean time from onset to death is 12 days.
The EU Orphan application process consists of multiple steps and a final decision from the European Commission normally occurs sometime after the summary report of the COMP. No assurances can be given that the final decision will designate Alferon N Injection® as an Orphan Medical Product for treatment of MERS.
"Alferon has great experimental potential as an early onset therapeutic for this dread disease. Hemispherx is dedicated to making Alferon available for MERS clinical trials, emergency uses and early access programs consistent with all applicable laws," according to Tom Equels, Hemispherx' President.
About Alferon N Injection® Alferon® N is the only natural source, multi-species alpha interferon currently approved for sale in the U.S. Alferon® N is approved in the U.S. for the treatment of refractory or recurring external genital warts caused by human papilloma virus in patients 18 years of age or older.
.. wie ich bin, stell ich mal wieder ein Chartbild rein. Gestern war ja ein Tag wo Investierte vom Hocker gefallen sind. Erst über 12% runter dann über 12 % rauf und keiner wusste wo die Reise eigentlich hingehen soll. Im Handelsverlauf immer wieder rauf ins plus runter ins minus und am ende steht nun ein Bullischer Doji Stern der hoffen lässt. Ich bin gespannt..................
Keine Kaufempfehlung !!! Es reicht wenn ich den Schrott im Depot habe :)
Previous studies (preclinical) have shown that both Ampligen and interferon are active against the flavivirus family of viruses which includes the West Nile virus and Zika virus.
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