Company Closes Final Agreement on GMP Certified Manufacturing
Facility; Expects International Sales to Begin During the Second Quarter
Philadelphia, PA, Thursday, March 18, 2004: Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that it has completed the second and final agreement with Interferon Sciences (ISI), including the acquisition of all the worldwide rights on Alferon N® as well as an FDA approved biological production facility of 44,000 square feet located in New Brunswick, New Jersey.
On March 11, 2003, Hemispherx Biopharma executed two agreements with Interferon Sciences to purchase certain assets of ISI and consummated the first agreement. In the first transaction, the Company acquired the inventory of Alferon N Injection® and a limited license for the production, manufacture, use, marketing and sale of the product.
In the second agreement, the Company acquired all intellectual, proprietary and commercial rights to Alferon N® and other assets related to the product including, but not limited to, all real estate and machinery.
"We are excited that we have successfully completed the transaction, which gives us complete ownership of the Alferon N® technology," said Dr. William A. Carter, Hemispherx's CEO and President. "The closing of the agreement allows us to expand the Alferon N® Program, which consists of Alferon N Injection®, Alferon N LDO® and Alferon N Gel®, outside of the United States. We expect to start clinical trials and generate sales with Alferon N® internationally in the second quarter of this year."
About Alferon N®
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 refractory papilloma infections (HPV) and is also approved for sale by various regulatory agencies worldwide.
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(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®) 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 Ampligen® 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® 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.