Hemispherx BioPharma, Inc (NYSEMKT:HEB) announced that it has entered into a Clinical Trial, Sales, Marketing, Distribution, and Supply Agreement with Scientific Products Pharmaceutical Co. LTD (SCIEN) located in Riyadh, Saudi Arabia. The contract covers Saudi Arabia, United Arab Emirates, Kuwait, Oman, Qatar, and Bahrain, thus expanding Hemispherx Early Access Programs (EAP) globally. The agreement also calls for SCIEN to purchase certain quantities of Hemispherx’s clinical grade interferon alfa-n3 for investigative use in individuals who are exposed to and show early onset symptoms of the coronavirus that causes MERS. MERS was first identified in Saudi Arabia in 2012, and can cause severe acute respiratory illness with symptoms of fever, cough, and shortness of breath as well as death. Some infected people developed pneumonia and experienced gastrointestinal symptoms including diarrhea, nausea/vomiting, and kidney failure. MERS has a fatality rate of about 36% and the mean time from onset to death is only about 12 days.
Tom Equels, CEO, stated “We are grateful to be able to undertake this important project with Saudi Arabia’s premiere pharma company. This is the natural next step to our successful Orphan Drug Designation (ODD) in the European Union regarding Alferon® as a therapy for MERS, a deadly virus, for which there is no currently approved therapy.”
On January 6, 2016, Hemispherx announced that the European Medicines Agency (EMA) had forwarded to the Company both its Public Summary of Opinion (PSO) and its record designation approving the Orphan Medicinal Product Designation for Alferon N Injection®, also known as interferon alfa-n3, as a potential treatment of MERS.
The EMA approved the opinion of the Committee for Orphan Medicinal Products (COMP) that the medicinal product, interferon alfa-n3, satisfies the criteria for designation and established that no satisfactory method for treating MERS was authorized in the EU at the time of designation.
Alferon N Injection® is currently the only product granted Orphan Drug status in the EU to treat MERS.
Interferons such as “interferon alfa-n3” are natural substances produced by the body that have a number of actions; one of these is to help fight viruses. The MERS virus overcomes the body’s natural defenses by stopping its own interferons from working properly. It is hypothesized that giving additional interferon in the form of interferon alfa-n3 may help to restore the body’s defense against the MERS virus, including both an antiviral action and an immunopotentiating action directed against the virus. (Original Source)
Shares of Hemispherx are up 18.40% to $0.15 in pre-market trading. HEB has a 1-year high of $0.29 and a 1-year low of $0.06. The stock’s 50-day moving average is $0.15 and its 200-day moving average is $0.13.
Hemispherx Biopharma, Inc. is a biopharmaceutical company, which engages in the clinical development of new drug therapies based on natural immune system enhancing technologies for the treatment of viral and immune based disorders.