PDF   Print   View All
May 21, 2003
Hemispherx Announces Acceleration of Manufacturing Process of Alferon N
Higher Product Demand Anticipated in View of Increased Incidence of HPV Reported by Federal Agencies

Philadelphia, PA, Wednesday, May 21, 2003: Hemispherx Biopharma, Inc. (AMEX: HEB) today announced that it has accelerated several production steps in the manufacturing of its lead compound, Alferon N, to target the fulfillment of anticipated orders. These decisions have been taken to meet the changing goals of technology acceleration, manufacturing agility, equipment productivity targets and time-to-market requirements.

“We are pleased to have reached the point of full insight into important factors affecting the manufacturing enabling us to accelerate the process, which brings us ahead of our initial schedule and which should further increase productivity and cost-effectiveness,” said Dr. William A. Carter, CEO of Hemispherx.

As part of an acquisition of the assets of Interferon Sciences, announced on March 12, 2003, Hemispherx obtained an FDA approved production facility in excess of 36,000 sq. feet. The Company proceeds with converting the inventory of Alferon N into bottled and final product. The drug inventory has a value of more than $ 7 million, based on its market value to wholesale customers, including State and Federal Agencies and Medicare. For historical purposes, the Wholesale Acquisition Cost has been $ 137.84 for 5 million iu/ml with a Average Wholesale Price of $ 165.41. The total asset value of the Company increased 45% as a result of the acquisition of certain assets of Interferon Sciences, with, for accounting purposes, the inventory valued according to standards set by the Financial Accounting Standards Board.

About HPV
The market for sexually transmitted diseases (STD’s) in the healthcare industry is worth $ 16 billion a year. There are presently 20 million people infected with the HPV virus in the United States alone. These figures are from reported cases, the numbers may be even higher because of unreported cases; this disease state is very personal and deemed socially embarrassing. This year alone, 5.5 million people in the U.S. will acquire the HPV infection and the numbers of incidents are further growing dramatically.

Long Term Sequelae of Untreated HPV
Some types of HPV are well established to be the cause of cervical cancer and recent research suggest HPV to be associated with the Vulvar Vestibulitis Syndrome (VVS). Vulvar vestibulitis, a type of vulvodynia, affects many American women. Patients typically present with a history of intermittent or continuous, localized, vulvar pain and frequently cannot tolerate sexual intercourse. Based on scientific evidence, it also seems probable that even mild HPV infections and cervical dysplasia may decrease fertility simply by preventing penetration of the sperm into the cervical canal.

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 a specific indication of STD (refractory condylomata acuminata) and is also approved for sale in certain other countries, including Hong Kong (Republic of China) and Singapore.

Contact Information for Health Care Professionals
To learn more about potential treatment, physicians should contact our ALFERON ACCESS PROGRAM by phone at 1-888-ALFERON or by fax at 1-888-FAXX AFN, visit our website www.hemispherx.net under the Product Section or look in the Physician Desk Reference (PDR) . Health Care Professionals interested in clinical trials should contact the Medical Director at Hemispherx Biopharma. Reimbursement information can be obtained by contacting the Medical Services Department at our New Brunswick location by phone at 732-249-3250. For reference purposes, the National Drug Code (NDC) of Alferon N Injection® is 54746-001-01, the HCPCS Code is J9215 and the CPT Code for administration is 90782.

About Hemispherx

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. 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.