Hemispherx Biopharma Gains Regulatory Approval of Alferon Under the Brand Name "Naturaferon" in Argentina
PHILADELPHIA, Jan 26, 2012 (GlobeNewswire via COMTEX) -- Hemispherx Biopharma, Inc. HEB -19.15% (the "Company" or "Hemispherx") today announced that ANMAT (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica), the agency responsible for the national regulation of drugs, foods and medical technology in Argentina, has approved the sale and distribution of Alferon N Injection(R) (under the brand name "Naturaferon") in Argentina. In June 2010, Hemispherx agreed to provide GP Pharm an option to market Alferon N Injection(R), its FDA-approved natural interferon, in Argentina and other Latin America countries. In December 2010, GP Pharm exercised this right and in July 2011 GP Pharm submitted an application for approval to ANMAT. Alferon N Injection(R) (Interferon alfa-n3 (human leukocyte derived)) is already approved in the US for the treatment of refractory or recurring external condylomata acuminate (genital warts) in patients 18 years of age or older. A major multi-million dollar investment scale-up of Alferon N Injection(R) manufacturing is underway at Hemispherx's New Brunswick, NJ facility.
According to a World Health Organization report 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."
Mr. Thomas Equels, Executive Vice Chairman of Hemispherx, stated "This approval is the result of Hemispherx's global business development initiatives which it plans to continue and to expand. It also reflects the increased capability of Hemispherx clinical and regulatory team to manage regulatory environments outside the US and to gear up to comply with import-export regulations in various countries. We are confident about the commercial opportunities for Alferon N Injection(R) in Argentina and pleased with the progress GP Pharm has made as is evidenced by this approval and parallel programs planned for Latin America."
Dr. Jorge Candal, Medical Director of GP Pharm, said, "We are pleased that ANMAT has understood the effectiveness of the unique technology platform represented by Alferon N Injection(R). We believe it can make a significant health impact in the lives of numerous patients in Argentina."
Jorge Braver, President of GP Pharm, said, "We are very excited about the approval of Alferon N in Argentina, and we look forward to providing it to patients in Argentina who will benefit from this unique, natural interferon."
Hemispherx continues to undertake its projected approximately $6.5 million expansion to its Good Manufacturing Process (GMP) manufacturing facility in New Brunswick, New Jersey including capital improvements, system upgrades and the introduction of building management systems to enhance production of our three products: Alferon N Injection(R), Alferon(R) LDO and Ampligen(R). One of the primary goals for these enhancements to our FDA licensed facility is to accommodate larger production volumes of Alferon N Injection(R) for anticipated global requirements.
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 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(R) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(R) and Alferon(R) LDO. Ampligen(R) 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(R)). 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(R) and Alferon(R) 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.