Hemispherx Biopharma Signs Option Agreement for Ampligen with Fujisawa Pharmaceutical Company
PHILADELPHIA–(BUSINESS WIRE)–Feb. 18, 2004–Company Receives Initial Payment in Potentially Multi Million Dollar Distribution Agreement for CFS Treatment
Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that Fujisawa Deutschland GmbH, a subsidiary of Fujisawa Pharmaceutical Co., Ltd, a leading international pharmaceutical company, has entered into an option agreement with the intent of becoming a distributor for the Company’s Ampligen(R), for the potential treatment of Chronic Fatigue Syndrome (CFS) in Germany, Switzerland and Austria. An option fee of 400,000 Euro has been paid pursuant to the terms of the option agreement.
The Agreement gives Fujisawa the exclusive right to enter into a distribution agreement with Hemispherx for the described territory at or before an undisclosed date. Upon execution of the Distribution Agreement, Fujisawa will pay a fee to Hemispherx which, when followed by several additional milestone payments, could result in a multi-million dollar payment to Hemispherx.
On January 30, 2004 the Company announced the completion of the placebo-controlled dosage stage of the Phase 3 clinical trial for Chronic Fatigue Syndrome. Clinical data is expected to be presented at peer-reviewed scientific meetings in the second quarter of this year.
About Fujisawa Pharmaceutical Co., Ltd
Fujisawa Pharmaceutical Co., Ltd, based in Osaka, Japan. is a leading pharmaceutical manufacturer and actively is developing its international operations in North America, Europe, and Asia. Its European subsidiary, Fujisawa Deutschland GmbH, is headquartered in Munich, Germany. Since its founding in 1894, Fujisawa has been a leading manufacturer and marketer of pharmaceuticals in the world’s major markets. With sales of over $ 2 billion, Fujisawa employs more than 8,000 people worldwide.
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About Chronic Fatigue Syndrome
CFS is defined by various governmental agencies as a serious debilitating disease in which patients suffer complex symptoms, including profoundly disabling fatigue, flu-like symptoms, headaches, sore throat, joint and muscle pain, mental fogginess, depression and sleep disorders. The U.S. Center for Disease Control and Prevention has added CFS to its top priority list of emerging infectious diseases. CFS is estimated to affect over 500,000 people in the U.S., and an equal number in Europe. At present, there is no other specific treatment available for CFS and no alternative drug appears to be under development in recognized clinical trials.
About Ampligen, an Experimental Immunotherapeutic
Ampligen(R) is an experimental, double stranded RNA drug acting potentially as an immunomodulator and antiviral. Based on in vitro studies, the experimental product, Ampligen(R) is believed to stimulate the immune system as well as inhibit the virus directly. The experimental product is currently in a Phase 3 clinical trial for the potential treatment of CFS and in two Phase 2b clinical trials for the potential treatment of HIV/AIDS. Treatment IND status for Ampligen(R) and CFS has already been recognized by various regulatory bodies.
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(R) and the experimental immunotherapeutics/antivirals Ampligen(R) and Oragens(TM). 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(R)) and GMP certified manufacturing facilities for its novel pharma 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 Oragens(TM)) 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 Alferon(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications including SARS.
The Alferon(R) 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.