|September 04, 2003
|HEMISPHERX BIOPHARMA SIGNS AGREEMENT WITH GUANGDONG MEDICINE GROUP CORPORATION
| Partnership for Clinical Program, Sales and Distribution in the People’s Republic of China for the Treatment of HCV and HIV
Philadelphia, PA, Thursday, September 04, 2003: Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that it has signed an Agreement with Guangdong Medicine Group Corporation (www.gdmg.com.cn) to organize clinical trials, marketing, sales and distribution for both of its lead compounds, Alferon N® and Ampligen® in the People’s Republic of China.
The agreement stipulates that the Guangdong Medicine Group Corporation (GMC) will conduct clinical trials with Alferon N Injection®, a natural source, multispecies alpha interferon product, for the treatment of HCV and with Ampligen®, a double stranded RNA experimental compound acting potentially as an immunomodulator and antiviral, for the treatment of HIV. All costs related to these trials are covered by GMC. Furthermore, GMC will develop and implement marketing and promotional program, built out of a dedicated sales force and organize distribution through their large-scale medical logistic center.
About Guangdong Medicine Group Corporation
GMC is in the business of providing pharmaceutical distribution, sales and regulatory support including the organization of clinical trials in the People’s Republic of China. The Company originally was part of State Drug Administration (SDA). The Company has a staff and workforce of over 1000 people, has a 1.4 million square feet storage and transportation facility, owns 330 Medicine Chain Stores, runs three pharmaceutical enterprises and controls 20 associate enterprises.
About Ampligen® and Alferon N®
Ampligen® is an experimental, double stranded RNA drug acting potentially as an immunomodulator and antiviral. Based on in vitro studies, Ampligen® is believed to stimulate the immune system as well as inhibit viruses directly. The product is currently in Phase 3 clinical trials for the potential treatment of Chronic Fatigue Syndrome (CFS) and in two Phase 2b clinical trials for the potential treatment of HIV/AIDS.
Alferon N® (Interferon alfa-n3, human leukocyte derived) is a highly purified, natural source, glycosylated, multispecies alpha interferon product, composed of eight forms of high purified alpha interferon. It is the only natural-source, multispecies alpha interferon currently sold in the U.S. for the treatment of genital HPV (refractory condylomata acuminata) and is also approved for sale in certain other countries, including Hong Kong (People’s Republic of China) and Singapore.
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 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) 398-6223
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. 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.