Stock Update (NYSEMKT:HEB): Hemispherx BioPharma, Inc Europe N.V./S.A. Receives Positive Opinion on Application for Orphan Designation by the EMA Agency for Alferon N Injection
Hemispherx BioPharma, Inc (NYSEMKT:HEB) 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). – See more at:
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. (Original Source)
Shares of Hemispherx Biopharma closed last Friday at $0.15. HEB has a 1-year high of $0.36 and a 1-year low of $0.14. The stock’s 50-day moving average is $0.17 and its 200-day moving average is $0.20.
Hemispherx Biopharma Inc is a specialty pharmaceutical company. It is engaged in the clinical development of new drug therapies based on natural immune system enhancing technologies for the treatment of viral and immune based chronic disorders.