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Hemispherx Biopharma Announces Plans To File For Regulatory Approval Of Ampligen(R) To Treat Chronic Fatigue Syndrome (CFS) In Three Additional Latin America Countries

Stocks in this article: HEB

PHILADELPHIA, March 10, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx"), announced that it and its partner in Latin America, GP Pharm, are planning on making applications in Chile, Peru and Uruguay for regulatory approval of Ampligen® to treat CFS.

Jorge Braver, President of GP Pharm, said, "In Latin American countries, in order to file for regulatory approval of a product, companies must first gain clearance of the trademarks in each country. We have now received  notification of clearance of the trademark "Rintamod" (Ampligen® in the US) in these three countries and are now planning on making the filings for regulatory approval."

Thomas K. Equels, Executive Vice Chairman of Hemispherx, said, "This is our next step in Hemispherx's  global strategy for Ampligen® following our July 18, 2012 announcement regarding a filing for regulatory approval of Ampligen® ('Rintamod') to treat CFS in Argentina."

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. For more information please visit www.hemispherx.net .

About GP Pharm

GP Pharm SA headquarters are located in Barcelona, Spain with operations in each major country in Latin America either directly or through local partners. Its activities are focused on research; development and marketing of its injectable products made by others and by GP Pharm SA based on its proprietary drug delivery systems including microspheres and liposomes. GP Pharm's new production plant recently achieved EU GMP approval and started manufacturing operations, producing the first batches of its own products and also for some contract manufacturing partners. Its facilities are also designed to be FDA GMP compliant. GP Pharm also has a centralized free-zone distribution facility in Uruguay for its own products as well as its partners' products.

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