Hemispherx Comments on $500+ Million Market Opportunity for Ampligen®, the Only Late Stage ME/CFS Candidate in the U.S.
January 23 2018 - 8:30AM
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.
Cautionary StatementSome 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).
ContactHemispherx Biopharma Phone Number:
800-778-4042 Email: IR@hemispherx.net
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