Hemispherx Biopharma, Inc., a specialty pharmaceutical company, engages in the clinical development of new drug therapies based on natural immune system improving technologies for the treatment of viral and immune based chronic disorders. The company’s strategic focus is derived from four applications of its two core pharmaceutical technology platforms Ampligen and Alferon N Injection. The commercial focus for Ampligen includes application as a treatment for CFS and as an influenza vaccine enhancer (adjuvant) for both therapeutic and preventative vaccine development. Alferon N Injection is an FDA approved product with an indication for refractory or recurring genital warts. Alferon LDO (Low Dose Oral) is a formulation under development targeting influenza. The company’s primary pharmaceutical product platform consists of its experimental compound, Ampligen, its FDA approved natural interferon product, Alferon N Injection, and its experimental liquid natural interferon for oral administration, Alferon LDO (Low Dose Oral). Ampligen Ampligen is an experimental drug undergoing clinical development for the treatment of CFS. The company’s drug technology utilizes specifically-configured RNA. Its double-stranded RNA drug product, trademarked Ampligen, is an experimental, unapproved drug, that would be administered intravenously. Ampligen has been assigned the generic name rintatolimod by the United States Adopted Names Council (USANC) and has the chemical designation poly(I) poly(C12U). In 2012, the company filed a new drug application for Ampligen with the 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. Alferon N Injection Alferon N Injection is the registered trademark for the company’s injectable formulation of natural alpha interferon, which is approved by the FDA for the treatment of certain categories of genital warts. Alferon is the only natural-source, multi-species alpha interferon currently approved for sale in the U.S. for the intralesional (within lesions) treatment of refractory (resistant to other treatment) or recurring external genital warts in patients 18 years of age or older. Certain types of human papilloma viruses (HPV) cause genital warts, a sexually transmitted disease (STD). Alferon N Injection contains a multi-species form of alpha interferon. Alpha interferons are manufactured commercially in three ways: by genetic engineering, by cell culture, and from human white blood cells. Research and Development The company’s research and development projects are targeting treatment therapies for CFS, various cancers (as adjunctive therapy), and other viral diseases, such as prevention and treatment of seasonal and pandemic H1N1 or influenza. In 2012, the ANMAT approved the sale and distribution of Alferon N Injection (under the brand name Naturaferon) in Argentina. Alferon LDO (Low Dose Oral) Alferon LDO [Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)] is an experimental low-dose, oral liquid formulation of Natural Alpha Interferon. Patents and Non-Patent Exclusivity Rights As of December 31, 2013, the company had 25 patents worldwide with 50 additional pending patent applications comprising its intellectual property. In 2013, the company granted four new patents, one in Singapore for the use of Ampligen to initiate innate immunity and to treat or prevent viral infections and tumors, and three for the use of Alferon LDO to treat bacterial or protozoan infections in Australia, New Zealand and Singapore. With respect to Ampligen, the main U.S. CFS treatment patent (#6,130,206) expires October 10, 2017. Significant Events In July 2014, Hemispherx Biopharma, Inc. announced a strategic alliance to develop multiple projects with Bioclones (Pty) Ltd. In October 2014, Hemispherx Biopharma, Inc. has announced new research collaborations designed to develop therapeutic cocktails against Ebola which may overcome the emergence of drug resistance due to Ebola virus mutation. History Hemispherx Biopharma, Inc. was founded in 1990.
hemispherx biopharma inc (HEB:NYSE Amex)
One Penn Center
1617 JFK Boulevard
Philadelphia, PA 19103
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