PHILADELPHIA, Sept. 17, 2015 (GLOBE NEWSWIRE) — Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the “Company” or “Hemispherx”), announced today the approval by the Board of Directors for a Patient Assistance Program for the open-label AMP-511 study of Ampligen® in Chronic Fatigue Syndrome (CFS) patients. Recently the company announced the first increase in the cost of the drug in 17 years. The Patient Assistance Program will allow the patients currently on the open-label treatment protocol to continue to receive the drug, through March 2016, at the cost-recovery rate in effect when they entered the study.
“We recognize that any increase in cost is a burden for a patient and wanted to try to ease that burden as best as possible,” said Thomas Equels, President. Under the FDA permission to carry out the AMP-511 study protocol, Hemispherx is authorized to charge for the drug at a cost-recovery level which is limited to the applicable costs of manufacturing and distributing the drug, without any profit. The cost set under the protocol in 1999, however, is far below the current cost of making the drug available to patients in the study. “It was a tough decision to actually start passing along these increased costs, knowing the impact on these patients and their families, however, the larger burden would have been to close this safety study,” stated Equels.
The Institute of Medicine this past year issued a report detailing the seriousness of this disease and issued guidelines to assist physicians in diagnosing the illness. The report stated there is upwards of 2.5 million Americans suffering with this disease. With no approved therapies, many CFS patients are completely debilitated by this illness. Many drug companies offer patient assistance programs to help patients with the cost of a medication. Hemispherx has chosen to extend this approach to the participants in the AMP-511 study.
Ampligen®, an experimental therapeutic, is a new class of specifically-configured ribonucleic acid (RNA) compounds targeted as potential treatment of diseases with immunologic defects and/or viral causation.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the 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
Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties including, but not limited to, general industry conditions and competition; general economic factors; the Company’s ability to adequately fund its projects; the impact of pharmaceutical industry regulation and healthcare legislation in the United States and internationally; trends toward healthcare cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Company’s ability to accurately predict the future market conditions; manufacturing difficulties or delays; dependence on the effectiveness of the Company’s patents and other protections for products; and the exposure to litigation, including patent litigation, and/or regulatory actions; as well as numerous other numerous other factors discussed in this release and in the Company’s filings with the Securities and Exchange Commission. The final results of these efforts and/or any other activities could vary materially from Hemispherx’s expectations. For instance, any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly delay, or preclude outright, approval of Ampligen® in the United States and other countries.
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, are based upon the current beliefs and expectations of the Company’s management, are subject to significant risks and uncertainties and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “intends”, “plans”, “potential”, “potentially”, “possible” and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Hemispherx that any of its plans will be achieved. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond Hemispherx’s control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. Examples of such risks and uncertainties include those set forth in the Disclosure Notice, above, as well as the risks described in Hemispherx’s filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Hemispherx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise revise or update this release to reflect events or circumstances after the date hereof. No evidence is suggested that Ampligen® will ever be commercially approved for the new potential treatment indications mentioned in this release.
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