|November 20, 2003
|HEMISPHERX BIOPHARMA APPOINTS DR. ANTONIO ESTEVE TO ITS BOARD OF DIRECTORS
|Executive Committee Member of Key European Partner to Play Active Role in European Development of Alferon®
Philadelphia, PA, Thursday, November 20, 2003: Hemispherx Biopharma, Inc. (AMEX: HEB) announced today the appointment of Dr. Antonio Esteve, PhD, to its Board of Directors. Dr. Esteve brings years of successful leadership experience to Hemispherx. Presently, Dr. Esteve is a Member of the Executive Committee and Director Scientific and Commercial Operations of Laboratorios del Dr. Esteve, Spain (www.esteve.es). Dr. Esteve also serves on the Board of Directors of Discovery Laboratories (Nasdaq: DSCO).
Laboratorios del Dr. Esteve, founded in 1929, is privately owned and dedicated to the manufacture of a broad range of active pharmaceutical ingredients and pharmaceutical specialties. Esteve has successfully expanded its commercial activities into more than 100 countries around the world and has manufacturing plants in Europe, America and Asia. The company has a workforce of 2,200 employees and had year 2002 sales of over 700 Million Euro.
In March 2002, Hemispherx S.A., a subsidiary of Hemispherx Biopharma, entered into a Sales and Distribution Agreement with Esteve. Pursuant to the terms of the Agreement, Esteve was granted the exclusive right to market Ampligen® in Spain, Portugal and Andorra for the treatment of Chronic Fatigue Syndrome (CFS). In addition to other terms and other projected payments, Esteve agreed to conduct, at its expense, certain clinical trials using Ampligen® in the patient population co-infected with Hepatitis C and HIV viruses. The preparation for this trial is in its final stage. No drug is presently approved in either the EU or North America for treatment of the dual infection, which is becoming a progressively common occurrence in HIV-infected individuals worldwide.
“The Management of Laboratorios del Dr. Esteve has always believed in the potential of the Ampligen® Program for CFS and HIV, hence the existing Agreement between both of our companies.” explains Dr. Antonio Esteve,”I am excited to become a part of Hemispherx’s developments now that the Phase 3 Clinical Trial for CFS is in its final stage. I also expect to have the opportunity to assist the Hemispherx team in its upcoming NDA filing and in diverse scientific and business programs, especially in Europe.”
Dr. Antonio Esteve will also play an active role in the development of the Alferon® Program for Europe. The Company is currently negotiating with several potential strategic partners to implement a regulatory expansion and initiate sales in the E.U. Alferon® is the only fully natural form of alpha interferon approved for commercial sales in North America.
Hemispherx Biopharma, based in Philadelphia, is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of viral and immune-based chronic disorders. Its flagship products include Alferon N® and the experimental immunotherapeutics/antivirals Ampligen® and Oragens™. These novel proteins, approved for a category of STD infection, and experimental nucleic acids are being developed for globally important chronic viral diseases and disorders of the immune system including HPV, HIV, CFS and Hepatitis. Its platform technology includes large and small agent components for potential treatment of various chronic viral infections. Hemispherx has approximately 400 patents comprising its core intellectual property estate, a fully commercialized product (Alferon N®) and GMP certified manufacturing facilities for its novel pharma products. For more information please visit www.hemispherx.net
Hemispherx Biopharma, Inc.,
Dianne Will, Investor Relations
(518) 398-6222, Fax: (518) 398-6369
HEB's Web Site: 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 AmpligenÒ and Oragensä) 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. Only Clinical Studies under well-controlled conditions can establish efficacy and safety of any product. Clinical trials for other potential indications of the approved biologic AlferonÒ do not imply that the product will ever be specifically approved commercially for these other treatment indications including SARS. The Alferon® asset for overseas sales for a category of STD is currently being acquired by the Company as part of a multi-step purchase contract of inventory, intellectual property, commercial licenses and GMP approved facilities, which house the biological operations.