FDA charges Hemispherx with false and misleading Ampligen promote.

On July 17, 2000, the U.S. Food and Drug Administration (“FDA”) disclosed a letter to Hemispherx Biopharma, Inc. (AMEX Symbol: HEB $7 1/8 per share). The letter detailed specific press releases and disclosures on Hemispherx’s website that constituted promotion of Ampligen as safe or effective in violation of FDA regulations. The FDA stated “your promotional materials are false and misleading in that they fail to disclose facts that are material in light of representations made about Ampligen.” In particular, Hemispherx failed to disclose risk information associated with the use of Ampligen. The FDA stated “toxicities that have been reported in dose-escalating studies of Ampligen in HIV-infected patients include, but are not limited to, flushing, chills, fever, chest tightness, nausea, malaise, shortness of breath, flu-like symptoms, leukopenia, neutropenia, and leukocytosis.”

Hemispherx first received a letter from the FDA on October 15, 1998. The July 7th letter is the second Hemispherx has received regarding Hemispherx’s promotion Ampligen as safe and effective while the product was under investigation. The letter stated that the FDA’s Division of Drug Marketing, Advertising and Communications “has concluded that Hemispherx is promoting Ampligen as safe and effective prior to approval, in violation of the Federal Food, Drug, and Cosmetic Act and its implementing regulations.” The FDA requested Hemispherx immediately cease dissemination of materials or activities that contain claims, representations, and conclusions concerning the safety or effectiveness of Ampligen. The FDA requested Hemispherx respond to this letter in writing by July 21, 2000.

Short selling involves a risk not associated with the purchase of stock including, but not only limited to, unlimited loss and stock borrowing risks. Additional information is available upon request.