Philadelphia, PA, Monday, October 01, 2012: Hemispherx Biopharma, Inc. (NYSE MKT: HEB) (the “Company” or “Hemispherx”), announced that the Company has filed with ANMAT (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica), the agency responsible for the national regulation of drugs, foods and medical technology in Argentina, an amended NDA for the use of its natural-source Alferon N Injection® (under the brand name “Naturaferon”) in patients with chronic hepatitis C who have become refractory to recombinant interferon as a result of the appearance of neutralizing antibodies (NABs) against recombinant interferon. As previously announced, ANMAT has already approved the sale of Naturaferon in Argentina for the treatment of refractory or recurring external condylomata acuminata (genital warts).
Thomas Equels, Vice Chairman of Hemispherx, stated, “Hepatitis C affects over 800,000 people in Argentina with a particularly high prevalence in rural communities. Worldwide it is a major health problem with more than 170 million people infected. In a very high percentage of cases chronic infection eventually leads to cirrhosis and hepatocellular carcinoma. Because patients with hepatitis C who become refractory to recombinant interferon have few alternatives, Hemispherx hopes ANMAT will approve the amended NDA. There is no assurance, however, that ANMAT will approve the amended NDA.”
Jorge Braver, President of GP Pharm, Hemispherx’s marketing partner in Argentina, said “We are very excited about this opportunity to seek ANMAT approval of this additional indication for Alferon N Injection® in Argentina.”
In a recent peer-reviewed article published in the Journal of Interferon and Cytokine Research (Volume 32, pages 95-102; http://online.liebertpub.com/doi/pdfplus/10.1089/jir.2011.0069), Hemispherx provided an analysis of the incidence and clinical impact of NABs formed during treatment with recombinant interferons compared to natural interferons, such as Alferon N Injection®, across a wide range of human diseases. The fraction of relapsed and refractory patients was reported as statistically greater in NAB positive patients compared to NAB negative patients (p < 0.0001), whereas the percentage of responding patients was reported as higher in NAB negative patients (p < 0.001). Another analysis looked at relapsed and refractory NAB positive patients who were then switched to natural interferon. Across all the different diseases the authors reviewed, 33 out of 40 or 82% of these patients had their clinical response restored after switching to natural interferon.
The Company also reported that it renewed its agreement in the U.S. with Armada Health Care, LLC (“Armada”) (www.armadahealthcare.com) for the sales/marketing of Alferon N Injection®. Under this Agreement, once manufacturing of Alferon N Injection® recommences, the Company will manufacture and supply Alferon N Injection® to physicians and patients through Armada’s national network of specialty pharmacies.
DISCLOSURE NOTICE: The information in this press release includes certain “forward-looking” statements (explained below), including statements about the steps to potentially gain ANMAT approval of Alferon N Injection® for the treatment of hepatitis C. The final results of these and other ongoing activities could vary materially from Hemispherx’s expectations and could adversely affect the chances for ANMAT approval of Alferon N Injection® for this indication. These activities and the ultimate outcomes are subject to a variety of risks and uncertainties, including but not limited to risks that (i) that the application may not be accepted by ANMAT or such acceptance may be delayed and (ii) ANMAT may ask for additional data, information or studies to be completed or provided prior to approval. Any failure to satisfy ANMAT’s requirements could significantly delay, or preclude outright, approval of Alferon N Injection® for hepatitis C 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. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®), approved for sale in the U.S. for refractory or recurring external genital warts in patients 18 years of age or older. 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 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 own products and also for some contract manufacturing partners. Its facilities are also designed to be FDA GMP compliant. GP Pharm has a centralized free-zone distribution facility in Uruguay for its own products as well as its partners’ products.
Contact:
Hemispherx Biopharma, Inc.,
Dianne Will, Investor Relations
(518) 398-6222,
ir@hemispherx.net
HEB's Web Site: www.hemispherx.net
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “hopes,” “believes,” “plans,” “anticipates,” and similar expressions are intended to identify forward-looking statements. These statements are based on the Company’s current beliefs and expectations and represent the Company’s judgment as of the date of this release. 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.
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