PHILADELPHIA, July 18, 2012 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE:HEB) (the "Company" or "Hemispherx"), announced that it has submitted a new drug application to ANMAT (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica), the agency responsible for the national regulation of drugs, foods and medical technology in Argentina, under the ANMAT's Orphan Drug regulations.
Ampligen® is an experimental drug currently undergoing clinical development for the treatment of Chronic Fatigue Syndrome ("CFS") in the United States. Over its developmental history, Ampligen has received designation by the US Food and Drug Administration ("FDA") as an Orphan Drug, and has received authorization to distribute the drug under a Treatment IND. Ampligen represents the first drug in the class of large (macromolecular) RNA (nucleic acid) molecules to apply for New Drug Application ("NDA") review in the United States. Over 1,000 patients have participated in Ampligen clinical trials representing the administration of more than 90,000 doses.
Jorge Braver, President of GP Pharm SA, said: "We are pleased that this Orphan Drug application has been filed with ANMAT and we hope for a speedy approval because of the significant need here in Argentina for a drug to treat chronic fatigue syndrome. Approval of Ampligen as an Orphan Drug in Argentina should make Ampligen more widely available since, upon approval, we believe it will be reimbursed by the Health Services Authority (SSS), the central health authority in Argentina, for many patients who seek a treatment for CFS." GP Pharm is Hemispherx's partner in Argentina and responsible for the efforts toward commercialization there of both Ampligen and Alferon N Injection®.
Hemispherx had previously provided GP Pharm an option to market Alferon N Injection, its FDA-approved natural interferon, and Ampligen in Argentina and other Latin America countries. Mr. Thomas Equels, Executive Vice Chairman of Hemispherx, stated: "This application is the result of Hemispherx's ongoing business development initiative in Latin America for both Ampligen and Alferon N Injection."
In March 2012, Hemispherx announced the publication of a peer-reviewed article in PLoS One which provided additional analyses of the results from the AMP-516 Phase III Clinical Trial of Ampligen [rintatolimod, Poly (I) • (C12U)]. The report is entitled "A Double-Blind, Placebo-Controlled, Randomized, Clinical Trial of the TLR-3 Agonist Rintatolimod in Severe Cases of Chronic Fatigue Syndrome". Recently, researchers from the Centers for Disease Control and Prevention ("CDC") and Harvard School of Public Health published new data showing the profound economic impact of CFS on increasing healthcare costs of $452 million and decreasing CFS patient productivity by $1.2 billion in Georgia, a state with a population of approximately 5.5 million between the ages of 18-59 (Cost Effectiveness and Resource Allocation, 9:1, 2011).
In the study described in the PLoS One publication, analyses of the exercise tolerance data, showed an average improvement of 21% in subjects receiving Ampligen compared to placebo. In addition, the proportions of patients with exercise improvements of at least 25% and 50% were 1.7 and 1.9-fold greater for the Ampligen group versus placebo (p<0.05). A continuous responder analysis, which examined response improvements from 25% to 50% in 5% increments, showed a greater improvement in exercise tolerance for patients receiving Ampligen® versus placebo at every 5% increment above 25%. The article can be found at http://dx.plos.org/10.1371/journal.pone.0031334.
New analyses of data from the AMP-516 Trial also showed that patients on Ampligen® reduced their use of concomitant medications compared to patients receiving placebo. In particular, Ampligen® patients reduced their use of medications which may prolong the QT interval. Prolongation of the QT interval is a known risk factor for sudden cardiac death and arrhythmias. A greater portion of the placebo patients were found to have a significant prolongation of the QT interval compared to patients who had received Ampligen®, thereby creating a cardiac risk situation in the CFS patients. Cardiac death is one of three major causes of premature death in CFS, which affects predominantly women in their 40s. The article can be found at http://jrnlappliedresearch.com/articles/Vol10Iss3/Vol10%20Iss3Stouch.pdf.
DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking" statements (explained below), including statements about the remaining steps to potentially gain ANMAT approval of Ampligen® for the treatment of Chronic Fatigue Syndrome. 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 Ampligen®. 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 the Ampligen® 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® (FDA approved for a category of sexually transmitted diseases) 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. 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). 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.
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 "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.
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.