|October 04, 2001
|HEMISPHERX REPORTS ON PROGRESS IN EUROPE -- Steady Organizational Growth Since February 2000 Prepares Company For European Trials And Product Introduction
|Philadelphia, PA, Thursday, October 04, 2001: Hemispherx Biopharma, Inc. (AMEX: HEB), a leading biopharmaceutical company specializing in the development of nucleic acids to enhance anti-viral defense systems in the human body, reported today on the activities of its European subsidiary (Hemispherx Eu) since the opening of offices in Paris in February 2000. The Company’s lead drug product, Ampligen®, is in advance stages of clinical trials for use in treating Chronic fatigue Syndrome and HIV/AIDS.
The European office was initially staffed with a medical director, a pharmacist in charge of regulatory affairs, a general manager and a small support staff. All top managers came with extensive senior management experience with significant international Pharmaceutical corporations. The original management team remains in place today.
The European subsidiary was formed and the office opened to prepare for the introduction of Hemispherx products and to accelerate market penetration into the European market once full approval is obtained from the European equivalent of the United States Food and Drug Administration Agency (FDA), the European Agency for the Evaluation of Medical Products (EMEA). The intended products are Ampligen® for the treatment of Chronic Fatigue Syndrome and for the treatment of HIV/AIDS.
From a regulatory point of view the member countries of the European Economic Union (EEU) represent a common market under the jurisdiction of the EMEA. However, from a practical point of view, every country is different regarding developing relations with the medical community, patient associations and obtaining reimbursement for treatment from Social Security Agencies and insurance carriers.
Recognizing this the office has devoted its near term efforts to five specific targets in select countries:
1.) Increasing public awareness of Chronic Fatigue Syndrome (CFS)
The office has assisted in the set up and growth of a number of patient associations. The French association has grown from 10 members in the year 2000 to 1,800 currently. Every major country now has an active patient association with substantial membership who regularly meet and network.
The media has been made aware of the impact of the disease and as a result a number of Television shows in several countries as well as numerous articles in popular magazines have featured the disease and its enormous negative impact. As a further result of these efforts a book by a highly respected author will shortly be published.
Representatives of the office have submitted position papers and held follow up meetings with numerous government officials in a number of countries, including meetings at the parliamentary level, all designed to heighten awareness and pave the way for approval.
2.) Informing the medical community regarding CFS and HIV/AIDS
To accomplish this, the office has facilitated the publication of articles in prominent medical journals in several countries. The office staff has made presentations to several hundred leading specialist and researchers who have experience in the use of Ampligen®. This process has been thoroughly utilized in the United Kingdom, Belgium, France, Germany and Italy.
3.) Contacts and activities with Regulatory Agencies
The office maintains regular contact with the EMEA, keeping the agency aware of its activities so as to facilitate future filings. Earlier this year an application for “orphan” status for the use of Ampligen® in Chronic Fatigue Syndrome was turned down because the Board found that the prevalence of CFS was significantly above the 5 person per 10,000 limit required to grant orphan status.
This is not viewed as a discouraging event since it will open the door to a filing for a full license once the results of the nearly completed U. S. Phase III studies are in. The office is also preparing a new “orphan” drug application for Ampligen® in connection with treating HIV/AIDS in a specific category of patients where we believe we will be successful.
4.) The Expanded Access Program
Over 50 CFS patients were treated with Ampligen® in the United Kingdom, Austria and Belgum.
This was based on existing procedures in those countries allowing the use of a not yet fully approved drug on certain conditions, including limiting patient charge to the recovery of costs only.
Corresponding procedures are underway in several other countries at the request of locally based physicians.
5.) HIV/AIDS Trials
The office is in the process of implementing clinical trials in Europe for the use of Ampligen® in the treatment of HIV/AIDS on the basis of the new U. S. Protocols involving the use of the drug either in combination with “cocktail” therapies or alone as part of a strategic interruption of the “cocktail” therapies.
The office is also engaging in extensive activity containing more intermediate and long-term implications. The three leading examples of this are:
1.) Anticipating marketing and distribution programs
The staff is setting up preliminary logistics in order to be able to move quickly when marketing approval is obtained. This includes securing a pan-European delivery system of Ampligen® from a “good manufacturing practice” warehouse system, a network of approved Clinical Centers throughout Europe for the necessary intravenous infusion of the drug, and a pan-European billing and collecting system.
2.) Insurance, reimbursement and pharmaco-economic preparations
The staff is securing the applicable regulations in each country regarding reimbursement and insurance coverage and preparing preliminary submission forms for all situations. The staff, in conjunction with independent consultants, is preparing pharmaco-economic documentation showing that the use of Ampligen®, especially for CFS, may constitute a substantial savings factor as compared with the costs of other drugs and of hospitalization as presented at peer-reviewed scientific meetings.
3.) Development of a long-term strategic plan
The staff is finalizing a 5 year strategic plan based on the timing of the full EMEA marketing approval for the use of Ampligen® in the treatment of CFS and HIV/AIDS. The plan includes the specifics of staffing and offices in all major European countries, including sales and cost projections. Emphasis will be placed on distribution through existing infusion centers and on marinating a relatively flat, small and low cost corporate structure. In addition final decisions are being made regarding the European corporate structure from legal and financial point of view including the legal residence of a possible holding company.
Dr. Richard Pianni, Managing Director of Hemispherx Eu., commenting on the the overall state of the European operation said,” The tremendous progress we have made in less than two years from our inception is due to two main factors. First we were able to hire and then retain top-level managers at every corner of our business. The second factor actually gave rise to the first - the understanding on the part of these thoroughly knowledgeable professionals of the tremendous scientific potential of Ampligen® in regards to the two disease we are currently pursuing as well as its future potential in many other areas of disease.”
About Hemispherx Biopharma, Inc.
Hemispherx Biopharma, Philadelphia, PA, is an international biopharmaceutical company that has devoted nearly three decades to exploring, understanding, and mastering the mechanism of ribonucleic acid (RNA) drug technology. The Company’s lead drug product, Ampligen®, is currently in Phase III clinical trials for the treatment of Chronic Fatigue Syndrome and Phase IIb clinical trials for the treatment of HIV. The Company's longevity as a biomedical research and drug development institution, coupled with its record of enduring scientific achievement, is evidence of long-term commitment to these promising new classes of drugs for the chronically ill and to bring new therapeutic choices to the global health care community. For more information, please visit the company’s website at www.hemispherx.net.
Information contained in this news release other than historical information, should all be considered forward-looking and are subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risks of competition, changing market conditions, changes 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. Accordingly, actual results may differ materially from those in any forward-looking statements. Additionally, all the referenced investigational drugs and associated technologies of the company 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 judgement as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.
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