PHILADELPHIA, Jan. 9, 2008 (PRIME NEWSWIRE) -- Hemispherx Biopharma, Inc.
(AMEX:HEB) announced today that it has formally submitted to the United States
Food & Drug Administration ("FDA") detailed responses to all of the 14 questions
posed by the FDA concerning the Company's New Drug Application ("NDA") for
Ampligen(r), an experimental therapeutic, to treat Chronic Fatigue Syndrome
("CFS"). Hemispherx received the questions from the FDA on December 5, 2007, at
which point the application was deemed by the FDA as "not sufficiently complete"
to permit substantive review under 21 CFR 314.101(R). Consequently, the FDA's
consideration of the NDA was postponed, pending receipt of the Company's answers
to the questions.
The FDA questions spanned a range of clinical and preclinical topics. With the
exception of a topical product for skin cancer, no TLR type compounds have yet
received full regulatory clearance. TLR is an acronym for pharma compounds which
signal broad "host defense" responses against various pathogens and disease
conditions. Poly I: poly C12U (Ampligen(r)), an experimental therapeutic, is the
first in this class of RNA (nucleic acid) molecules now seeking
commercialization.
A recent independent study enumerated three primary causes of early death in CFS
populations at large (without administration of Ampligen(r)) that may be
attributable to the disease: 1) cardiovascular events, 2) suicide and 3)
untreatable life-threatening malignancies/tumors. In response to the FDA's
questions, as well as within the body of its NDA, Hemispherx addresses how
Ampligen(r), an experimental therapeutic, may address these and other high risk
aspects of CFS.
Only regulatory agencies can determine whether any experimental therapeutic,
including Poly I: Poly C12U (Ampligen(r)) is "safe and effective." At this time,
Ampligen(r), an experimental therapeutic, is only available in specific clinical
trial settings conducted under specific governmental authorizations. It has not
been determined to be "safe and effective" by any governmental body. Ampligen(r)
represents an entirely new class of RNA-based drug therapies. The Company's
prompt response to the questions posed by the FDA was made possible by the
broad-based team of clinical and scientific experts assembled during 2007, with
experience in successful global development of NDAs for new molecular entities
("NMEs"), such as Ampligen(r).
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is a biopharmaceutical 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(r) and the experimental therapeutics Ampligen(r), Alferon LDO and
Oragens(r). Alferon N Injection(r) is approved for a category of STD infection,
and Ampligen(r) and Oragens(r) represent a large portfolio of experimental RNA
nucleic acids being developed for globally important viral diseases, severely
debilitating disorders and biodefense applications. Hemispherx's platform
technology includes large and small agent components for potential treatment of
various severely debilitating and life threatening diseases. Hemispherx has in
excess of 100 issued patents comprising its core intellectual property estate, a
fully commercialized product (Alferon N Injection(r)) and a GMP certified
manufacturing facility for its novel pharma products. The Company is actively
engaged in further expansion of its intellectual property on a world wide basis
to reflect the global distribution of the various disorders which its platform
technology addresses. For more information please visit www.hemispherx.net.
Information contained in this news release other than historical information,
should be considered forward-looking and is subject to various risk factors and
uncertainties. For instance, the strategies and operations of Hemispherx involve
risk of competition, changing market conditions, change 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. Any
specifically referenced investigational drugs and associated technologies of the
Company (including Ampligen(r), Alferon LDO and Oragens) 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 judgment as of the date of this release. The Company disclaims,
however, any intent or obligation to update these forward-looking statements.
Clinical trials for other potential indications of the approved biologic Alferon
N Injection(r) do not imply that the product will ever be specifically approved
commercially for these other treatment indications.
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CONTACT: Hemispherx Biopharma, Inc.
Company Contact:
Dianne Will
518-398-6222
ir@hemispherx.net
CCG Investor Relations
Investor Contact:
Sean Collins, Sr. Partner
310-477-9800
