Hemispherx BioPharma (HEB)

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Hemispherx Biopharma Europe N.V./S.A. Submits Application for Orphan Medicine Designation to the EMA for Alferon N Injection(R) for Treatment of Middle East Respiratory Syndrome (MERS)

8:30 AM ET 7/15/15 | GlobeNewswire
Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx") announces that they have submitted an application for orphan drug designation to the European Medicines Agency (EMA) for Alferon N Injection(R), an experimental therapeutic, to treat Middle East Respiratory Syndrome (MERS). The EMA has determined the application to be valid, and the Committee for Orphan Medicinal Products (COMP) has initiated the official review process. It is anticipated that the COMP will give an opinion on the application within the next 90 days. There are significant benefits for achieving Orphan Designation, including eligibility for grants from EU and Member State programs. Designated orphan medicines are assessed for marketing authorization centrally in the European Union with reductions/waivers in the fees and costs of the overall regulatory process. The designation allows companies to make a single application to the European Medicines Agency, resulting in a single opinion and a single decision from the European Commission, valid in all EU Member States. Authorized orphan medications, once commercially approved, receive benefits including ten years of complete protection from market competition with similar medicines.

According to the Centers for Disease Control (CDC) Middle East Respiratory Syndrome Fact Sheet on the CDC website, the 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.

Recent Hemispherx collaborations with the National Institutes of Health (NIH), specifically National Institutes of Allergy and Infectious Disease (NIAID), using human cells in culture, suggest that Alferon(R) N may be effective either as a preventative and/or treatment of early MERS infection (http://www.hemispherx.net/content/investor/default.asp?goto=781). Similar positive inhibitory results with Alferon(R) N were obtained at the University of Texas (http://www.hemispherx.net/content/investor/default.asp?goto=786).

MERS-CoV and SARS-CoV are members of the same coronavirus family. Only MERS and SARS have high mortality rates in man as the other four human coronavirus family members are generally associated with mild, non-life-threatening, common cold symptoms. Only the MERS and SARS viruses inhibit the production of a key component of human immunity, IFN. IFNs have been previously established as useful to fight off a number of otherwise lethal viral infections. Hemispherx scientists have also conducted a medical literature survey of candidate MERS pharmaceuticals, focusing on interferons (IFNs) and inducers thereof. A comparison of drug sensitivity of a wide spectrum of clinically approved antiviral drugs including Alferon(R) against SARS-CoV by an independent research group in Singapore showed Alferon(R) to be among the most active in vitro antiviral agents (Tan EL, et al. Emerg Infect Dis. 2004;10(4):581-6).