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HEMISPHERX AND SCIEN ENTER TRIAL/SALES AGREEMENT.

Hemispherx Biopharma, Inc. 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.

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.

About Hemispherx Biopharma

Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection and the experimental therapeutics Ampligen and Alferon LDO. Ampligen is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Chronic Fatigue Syndrome. Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because both Ampligen and Alferon LDO are experimental in nature, they are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials.

Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection), approved for sale in the U.S. and Argentina. The Company's Alferon N approval in Argentina includes the use of Alferon N Injection (under the brand name Naturaferon) for use in any patients who fail, or become intolerant to recombinant interferon, including patients with chronic active hepatitis C infection. The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. About Scientific Products Pharmaceutical Co. LTD (SCIEN)

Scientific Products Pharmaceutical Co. LTD is a pharmaceutical company with its primary offices located at Tahlia Street, P.O Box 10485, Riyadh 11433 Saudi Arabia.

For more information, visit www.hemispherx.net.
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Publication:Worldwide Biotech
Geographic Code:7SAUD
Date:May 1, 2016
Words:579
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