ORLANDO, Fla., Jan. 23, 2018 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE American:HEB), focused on pharmaceutical research, today commented on the overall market opportunity for its Ampligen® drug candidate in treating Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), given the recent announcement by clinicians regarding the failure of Rituximab ME/CFS trial in Europe. See Link: http://simmaronresearch.com/2017/11/norwegian-rituximab-chronic-fatigue-syndrome-mecfs-trial-fails/ ME/CFS is a serious, debilitating condition that imposes a burden of illness on millions of people in the U.S. and around the world, leaving hundreds of thousands seriously disabled worldwide.
ME/CFS can cause significant impairment and disabilities that have negative economic consequences at both the individual and the societal level. At least one-quarter of ME/CFS patients are house- or bed-bound at some point in their lives (Marshall et al., 2011; NIH, 2011; Shepherd and Chaudhuri, 2001). The direct and indirect economic costs of ME/CFS to society have been estimated at $17 to $24 billion annually (Jason et al., 2008), $9.1 billion of which has been attributed to lost household and labor force productivity (Reynolds et al., 2004). High medical costs combined with reduced earning capacity often have devastating effects on patients’ financial status and their family life.
In the U.S., there are no approved treatments for ME/CFS. Ampligen®, which enjoys orphan drug status for ME/CFS, is the only drug in late-stage clinical development. The company has completed CFS Phase I/II/III studies in the U.S. for Ampligen®, which has demonstrated clinically significant improvements in patient exercise performance in two randomized, placebo-controlled pivotal trials and the FDA is requiring a confirmatory trial. Ampligen® is already approved in Argentina, where it is the first and only drug ever approved anywhere in the world as a therapy for ME/CFS.
The Company is focusing its NDA and confirmatory trials in the U.S. for severely debilitated ME/CFS patients on a target population of approximately ~100,000. The company estimates that a market penetration of only 10 percent would result in peak annual sales of over $500 million1. Hemispherx is in the final stages of producing commercial lots with some of its recently acquired funding, which are needed to launch Ampligen® in Argentina. Increasing Ampligen production is also essential for upcoming clinical activities in both ME/CFS and oncology to move forward in the U.S, Europe and Canada.
Dr. Daniel Peterson, a world renowned independent expert in the treatment of ME/CFS and in the clinical use of Ampligen® (or rintatolimod), states that it “… is a potentially useful drug for a subset of severely ill ME/CFS patients to improve quality of life and functional status. Based on extensive clinical experience and testing, rintatolimod has an excellent safety profile. In addition, there are clear outcome measures that can be used to assess the drug’s efficacy in planned confirmatory trials.”
“We are optimistic about the prospects for Ampligen® and its potential to help tens of thousands of people who currently have no treatment options. Our company is focused on getting Ampligen® to the final stage for regulatory approval for ME/CFS in the U.S. and preparing for an ME/CFS commercial launch in Argentina,” said Thomas K. Equels, chief executive officer of the company. Mr. Equels recently wrote an address to Hemispherx’s Stockholders and Employees about the importance of seeking an approved therapy for ME/CFS. The Stockholder/Employee Address can be found at (http://ir.hemispherx.net/Events_Presentations).
1Assuming an average of two vials per dose twice a week over 48 weeks.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc., is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx’s flagship products include Alferon N Injection® and the experimental therapeutic rintatolimod (tradenames Ampligen® or Rintamod®). Rintatolimod is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and life-threatening diseases. Because rintatolimod is experimental in nature, it is not designated safe and effective by the FDA for general use and is legally available only through clinical trials.
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.hemispherx.net. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. With regard to our NDA for Ampligen® to treat CFS, we note that there are additional steps which the FDA has advised us to take in our seeking approval. The final results of these efforts and/or any other activities could vary materially from our expectations. Any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly delay, or preclude outright, approval of Ampligen® in the United States and other countries. Approval of Rintamod® for CFS in the Argentine Republic does not in any way suggest that the Ampligen® NDA in the United States will obtain commercial approval. Also, it is noted that ANMAT approval is only an initial, but important, step in the overall successful commercialization. Namely, additional steps required for commercialization in Argentina will require, among others, an appropriate reimbursement level, appropriate marketing strategies, completion of manufacturing preparations for launch (including possible requirements for approval of final manufacturing, etc., and there are no assurances as to whether or when such multiple subsequent steps will be successfully performed to result in an overall successful commercialization and product launch).
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