Hemispherx Biopharma, Inc., a specialty pharmaceutical company, engages in the clinical development of new drug therapies based on natural immune system enhancing technologies for the treatment of viral and immune based chronic disorders in the United States. The company’s primary products include Alferon N Injection and the experimental therapeutic Ampligen. Alferon N Injection is approved for a category of STD infection, and Ampligen represents an experimental RNA being developed for globally important viral diseases and disorders of the immune system. Hemispherx' platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Alferon LDO (Low Dose Oral) is a formulation under development targeting influenza. In 2013, the company received a Complete Response Letter (CRL) from the FDA declining to approve its new drug application (NDA) for Ampligen for Chronic Fatigue Syndrome (CFS). Ampligen is an experimental drug undergoing clinical development for the treatment of CFS. Ampligen has received various designations, including Orphan Drug Product Designation (FDA), Treatment protocol (Expanded Access or Compassionate use authorization) with Cost Recovery Authorization (FDA). Ampligen represents the drug in the class of large (macromolecular) RNA (nucleic acid) molecules to apply for NDA review. Its drug technology utilizes specifically-configured RNA. The company’s double-stranded RNA drug product, trademarked Ampligen, is an experimental, unapproved drug that would be administered intravenously. Alferon N Injection is the registered trademark for the company's injectable formulation of natural alpha interferon, which was approved by the FDA in 1989 for the treatment of certain categories of genital warts. Alferon is the only natural-source, multi-species alpha interferon 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 [Interferon alfa-n3 (human leukocyte derived)] is a highly purified, natural-source, glycosylated, multi-species alpha interferon product. Alferon LDO (Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)) is an experimental low-dose, oral liquid formulation of Natural Alpha Interferon and like Alferon N Injection, should not cause antibody formation, which is a problem with recombinant interferon. Hemispherx has an FDA authorized protocol to conduct a Phase II, double-blind, adaptive-design, randomized, placebo-controlled, dose-ranging study of Alferon LDO for the prophylaxis and treatment of seasonal influenza of approximately 200 subjects. The company has collaborations designed to determine the potential effectiveness of Alferon N and Ampligen as potential preventative and/or therapeutic treatments for Ebola related disorders. Patents and Non-Patent Exclusivity Rights As of December 31, 2015, the company had 21 patents worldwide with 18 additional pending patent applications comprising its intellectual property. With respect to Ampligen, the main U.S. CFS treatment patent (#6,130,206) expires October 10, 2017. 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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