Hemispherx BioPharma, Inc (NYSEMKT:HEB) announces that they have submitted an application for orphan drug designation to the European Medicines Agency (EMA) for Alferon N Injection®, 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. (Original Source)
Shares of Hemispherx Biopharma closed yesterday at $0.201. HEB has a 1-year high of $0.40 and a 1-year low of $0.17. The stock’s 50-day moving average is $0.22 and its 200-day moving average is $0.23.
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.