Hemispherx Biopharma, Inc., an advanced specialty pharmaceutical company, announced that its European subsidiary, Hemispherx Biopharma Europe N.V./S.A gained a positive opinion from the Committee on Medical Products (COMP) 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.

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 per cent 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, president of Hemispherx.

Alferon N is the only natural source, multi-species alpha interferon currently approved for sale in the US. Alferon N is approved in the US for the treatment of refractory or recurring external genital warts caused by human papilloma virus in patients 18 years of age or older.