PHILADELPHIA, Aug. 17, 2011 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company" or "Hemispherx") today announced its authorized agent GP Pharm Argentina has submitted to the ANMAT (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica) regulatory agency responsible for the national administration of drugs, foods and medical technology for the approval of Alferon N Injection® for sales and distribution in Argentina. In June 2010, Hemispherx agreed to provide GP Pharm an option to market Alferon N Injection®, its FDA approved natural interferon, in Argentina and other Latin America countries as well. It is planned to be marketed under the brand name Naturaferon®. Alferon N Injection® is approved in the US for the treatment of refractory genital warts and a major scale-up of Alferon N Injection® manufacturing is underway at Hemispherx's New Brunswick, NJ facility.
According to the World Health Organization website on Human Papillomavirus (HPV), "Genital warts are very common and are highly infectious, and between 90% and 100% are caused by HPV genotypes 6 and 11. Although, they do not usually result in death, genital warts cause significant morbidity and entail substantial health care costs. Recurrence is common." Alferon N Injection® has been shown to be effective against refractory genital warts. Because Alferon N Injection® is developed directly from human leukocytes, patients have generally not been observed to develop antibodies in contrast to interferons (r-IFNs) developed by recombinant DNA technology. Application of r-IFNs may lead to antibodies against the r-IFN. The development of neutralizing antibodies usually indicates the loss of clinical efficacy.
Mr. Thomas Equels, Executive Vice Chairman of Hemispherx, stated, "We are confident about the potential opportunities for Alferon N Injection® in Argentina and pleased with the progress GP Pharm is making evidenced by the recent regulatory submission."
Dr. Jorge Candal, Medical Director of GP Pharm said, "We are confident that the regulatory agency will understand the effectiveness of the unique technology platform represented by Alferon N Injection®. We believe it can make a significant health impact in the lives of numerous patients in Argentina."
Hemispherx continues to undertake its approximately $4.4 million expansion to its Good Manufacturing Process (GMP) manufacturing facility in New Brunswick, New Jersey regarding capital improvements, system upgrades and the introduction of a building management system to enhance production of its three products: Alferon N Injection®, Alferon® LDO and Ampligen®. One of the primary goals for these enhancements to its FDA licensed facility is to accommodate larger production volumes of Alferon N Injection®.
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.
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.
Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen® and Alferon® LDO) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. The planning, completion, results or submission of clinical trials do not imply that any study product will ever be approved commercially for the studied or other treatment indications. The scale-up of Alferon N manufacturing could be delayed by various critical steps including those involved in construction, GMP compliance, formulation, packaging and labeling, as well as potential issues related to 3rd party vendors including without limitation various "fill and finish" procedures.