Hemispherx Biopharma Announces Major Breakthrough: Approval for
Commercial Sale of Rintatolimod (U.S. Tradename: Ampligen®) to
Treat Severe Cases of Myalgic Encephalomyelitis/Chronic Fatigue
Syndrome (ME/CFS) in the Argentine Republic
First Product
Approved for ME/CFS Indication Anywhere in the World
Breakthrough
Approval Provides Clear Path for Growth in Latin America and the
European Union
PHILADELPHIA, Aug. 24, 2016 (GLOBE NEWSWIRE) --
Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or
"Hemispherx"), announced that it has received approval of its New
Drug Application (NDA) from Administracion Nacional de
Medicamentos, Alimentos y Tecnologia Medica (ANMAT) for commercial
sale of rintatolimod (U.S. tradename: Ampligen®) in the Argentine
Republic for the treatment of severe myalgic
encephalomyelitis/chronic fatigue syndrome (ME/CFS). The
product will be marketed by GP Pharm, Hemispherx's commercial
partner in Latin America. We believe that rintatolimod is the
first drug to receive approval for this indication anywhere in the
world. We also believe that there are no other products in
the pipeline for approval, worldwide, for this debilitating
disease. A copy of the official approval from ANMAT,
translated in English, is available on the Company's website
at http://ir.hemispherx.net/Events_Presentations.
The approval was based on submission of two
pivotal studies, AMP-502 and AMP-516. Safety data also included
additional CFS and non-CFS studies for a total of over 800 subjects
including over 100 subjects with severe CFS who received
Ampligen® for one year or longer. Several post-approval
activities are required to be completed before product launch,
including manufacturing site inspections and reimbursement
evaluation by the Health Services Authority (SSS), the central
health authority in Argentina. "Working
closely with our partner in this effort, GP Pharm, our team at
Hemispherx addressed all medical and scientific issues presented by
ANMAT and deserves great credit for this major success. At
Hemispherx, we may be small by big pharma standards, but our
commitment to addressing this dire unmet medical need makes us
mighty," stated Hemispherx CEO Tom Equels.
Approval for commercial sale in Argentina provides
a platform for potential commercial sales in certain countries
within the European Union under regulations that support
cross-border pharmaceutical sales of licensed drugs. Hemispherx and
GP Pharm are now working to expand the approval of rintatolimod to
additional countries with a focus on Latin America. In Europe,
approval in a country with a stringent regulatory process in place,
such as Argentina, adds further validation for the product as the
Early Access Program (EAP) is launched in Europe.
"In Argentina, rintatolimod
(Ampligen) has just been commercially approved for the severe
disabling form of ME/CFS. The number of patients with ME/CFS
is estimated to be over three million worldwide, however, only a
portion of these have the severe and disabling form of the disease
which we are targeting with this drug," stated Tom Equels.
"Until now, there has been no commercially
available effective treatment and there are no advanced clinical
candidates, other than rintatolimod, that we are aware of. This
commercial approval in Argentina will dramatically improve our
ability to treat patients suffering from severe ME/CFS in Latin
America. We continue to work aggressively to clarify a path toward
approval for those with severe ME/CFS in the United States, where
we have Orphan Drug status, and therefore seven years of product
exclusivity upon approval. We are greatly encouraged by this
new regulatory approval in Argentina. This is the most significant
accomplishment to date in Hemispherx's plan to bring our drug to
severe sufferers of ME/CFS worldwide."
"We have worked diligently with
Hemispherx to get to this point, and are now preparing for the
commercial launch of rintatolimod for ME/CFS in Argentina,"
commented Jorge Braver, chief executive officer of GP Pharm Latin
America. "Looking ahead, we will continue to seek
approval in additional Latin American countries."
About
Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical
company engaged in the manufacture and clinical development of new
drug entities for treatment of seriously debilitating disorders.
Hemispherx's flagship products include Alferon N
Injection® and the experimental therapeutics rintatolimod
(tradenames Ampligen® or Rintamod®) and Alferon® LDO.
Rintatolimod is an experimental RNA nucleic acid being developed
for globally important debilitating diseases and disorders of the
immune system, including Chronic Fatigue Syndrome. Hemispherx's
platform technology includes components for potential treatment of
various severely debilitating and life threatening diseases.
Because both rintatolimod and Alferon® LDO are experimental in
nature, they are not designated safe and effective by a regulatory
authority for general use and are legally available only through
clinical trials. Hemispherx has patents comprising its core
intellectual property estate and a fully commercialized product
(Alferon N Injection®), approved for sale in the U.S. and
Argentina. The Company's Alferon N approval in Argentina includes
the use of Alferon N Injection (under the pending brand name
"Naturaferon") for use in any patients who fail or become
intolerant to recombinant interferon, including patients with
chronic active hepatitis C infection. The Company wholly owns and
exclusively operates a GMP certified manufacturing facility in the
United States for commercial products. For more information please
visit www.hemispherx.net.
Forward-Looking Statements
To the extent that statements in this press release are not
strictly historical, all such statements are forward-looking, and
are made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Words such as "intends,"
"plans," and similar expressions are intended to identify
forward-looking statements. The inclusion of forward-looking
statements should not be regarded as a representation by Hemispherx
that any of its plans will be achieved. These forward-looking
statements are neither promises nor guarantees of future
performance, and are subject to a variety of risks and
uncertainties, many of which are beyond Hemispherx's control, which
could cause actual results to differ materially from those
contemplated in these forward-looking statements. Examples of such
risks and uncertainties include those set forth in the Disclosure
Notice, below, as well as the risks described in Hemispherx's
filings with the Securities and Exchange Commission, including the
most recent reports on Forms 10-K, 10-Q and 8-K. You are cautioned
not to place undue reliance on these forward-looking statements,
which speak only as of the date hereof, and Hemispherx undertakes
no obligation to update or revise the information contained in this
press release, whether as a result of new information, future
events or circumstances or otherwise revise or update this release
to reflect events or circumstances after the date hereof.
Disclosure
Notice
The information in this press release includes certain
"forward-looking" statements including without limitation
statements about additional steps which the FDA may require and
Hemispherx may take in continuing to seek commercial approval of
the Ampligen® NDA for the treatment of Chronic Fatigue
Syndrome in the United States. The final results of these and other
ongoing activities could vary materially from Hemispherx's
expectations and could adversely affect the chances for approval of
the Ampligen® NDA in the United States and other countries.
The clinical studies referenced herein have been previously
reviewed by the FDA and are not, in and of themselves, a sufficient
basis for approval in the United States. Any failure to satisfy the
FDA regulatory requirements or the requirements of other countries
could significantly delay, or preclude outright, approval of the
Ampligen® NDA in the United States and other countries.
Information contained in this news release, other
than historical information, should be considered forward-looking
and is subject to various risk factors and uncertainties including,
but not limited to, general industry conditions and competition;
general economic factors; the Company's ability to adequately fund
its projects; the impact of pharmaceutical industry regulation and
healthcare legislation in the United States and internationally;
trends toward healthcare cost containment; technological advances,
new products and patents attained by competitors; challenges
inherent in new product development, including obtaining regulatory
approval; the Company's ability to accurately predict the future
market conditions; manufacturing difficulties or delays; dependence
on the effectiveness of the Company's patents and other protections
for products; and the exposure to litigation, including patent
litigation, and/or regulatory actions; and numerous other factors
discussed in this release and in the Company's filings with the
Securities and Exchange Commission. The final results of these
efforts and/or any other activities could vary materially from
Hemispherx's expectations. Approval of Ampligen® 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.
Company/Investor Contact:
Charles Jones
CJones & Associates Public Relations
888-557-6480
cjones@cjonespr.com
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Hemispherx Biopharma, Inc. via Globenewswire
HUG#2037056
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