Hemispherx Biopharma Announces Major Breakthrough: Approval for Commercial Sale of Rintatolimod...
(Thomson Reuters ONE) -
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(at)cjonespr.com
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq 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
Datum: 24.08.2016 - 16:18 Uhr
Sprache: Deutsch
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