UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
October 11, 2007
HEMISPHERX BIOPHARMA, INC.
(Exact name of registrant as specified in its charter)
Delaware 0-27072 52-0845822
(state or other juris- (Commission (I.R.S. Employer
diction of incorporation) File Number) (Identification No.)
1617 JFK Boulevard, Philadelphia, Pennsylvania 19103
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (215) 988-0080
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instruction A.2. below):
[ ] Written communications pursuant to Rule 425 under the Securities Act
(17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17
CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
Section 8 - Other Events
Item 8.01 Other Events.
On October 10, 2007, we filed a New Drug Application ("NDA") with the U.S. Food
and Drug Administration for our experimental therapeutic Ampligen(R) to treat
Chronic Fatigue Syndrome. We are also moving forward as planned with filings in
countries outside the United States. The NDA includes four well-controlled
trials, more than 1,200 trial subjects and 90,000 doses.
For more information, please see the October 11, 2007 press release attached
hereto as exhibit 99.1
Section 9 - Financial Statements and Exhibits
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
The following Exhibit is filed as part of this report:
Exhibit No. Description
Exhibit 99.1 Press Release dated October 11, 2007.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
HEMISPHERX BIOPHARMA, INC.
October 11, 2007 By: /s/ William A. Carter
--------------------------
William A. Carter M.D.,
Chief Executive Officer
Exhibit 99.1
Company/Investor Contact:
Dianne Will Sean Collins, Senior Partner
Hemispherx Biopharma, Inc. CCG Investor Relations
518-398-6222 310-477-9800
ir@hemispherx.net
Hemispherx Biopharma Files New Drug Application for Ampligen(R)
as Treatment of Chronic Fatigue Syndrome
NDA of investigational drug includes four well-controlled trials,
more than 1,200 trial subjects and 90,000 doses
Philadelphia, Pennsylvania--October 11, 2007--Hemispherx Biopharma, Inc. (AMEX:
HEB) announced today that it has filed a New Drug Application (NDA) with the
U.S. Food and Drug Administration (FDA) for its experimental therapeutic
Ampligen(R), also known as Poly I : Poly C12U, to treat Chronic Fatigue Syndrome
("CFS"). The Company is also moving forward as planned with filings in countries
outside the United States.
According to data from the Centers for Disease Control ("CDC"), Chronic Fatigue
Syndrome may now affect more than 1 million people in the United States alone,
causing an economic impact estimated at more than $9 billion annually. The
Centers for Disease Control refers to CFS as a "... disabling disease, as
disabling as other severe chronic conditions like multiple sclerosis, COPD
[Chronic Obstructive Pulmonary Disease] and rheumatoid arthritis" in their
ongoing public awareness campaign launched in 2006. The condition may also be
associated with early death due to secondary depression/suicide and cancer.
Over its developmental history, the experimental therapeutic Ampligen(R) has
received various designations, including Orphan Drug Product Designation (FDA),
Emergency (compassionate) Cost Recovery Sales Authorization (FDA) and
"promising" designation by the Agency on Health Research Quality (AHRQ). Four
well controlled, or pivotal, trials are now being reported in their entirety
within Hemispherx Biopharma's NDA submission, which covers more than 1,200
subjects evaluated with approximately 90,000 dose administrations.
The experimental therapeutic was originally discovered and developed at The
Johns Hopkins University and thereafter licensed to Hemispherx. On December 29,
2006, the FDA received the Company's pre-submission of pre-clinical information
and assigned an NDA number. The Company will now move forward promptly with a
series of scientific and medical peer-reviewed publications on the audited
database contained within the NDA application.
William A. Carter, M.D., Chief Executive Officer and Chairman of Hemispherx,
commented: "The comprehensive data package being submitted today has been
possible because of the guidance, and scientific support, of the FDA, the CDC
and CFS Advisory Committees to both the government and the private sector. Our
profound gratitude goes out to the teams of independent clinical investigators
around the country and especially, to the individuals afflicted with CFS who
supplied the courage and will to sustain the research, clinical and regulatory
communities in their continuing search for better understanding and management
of CFS."
The bioactivity of the experimental therapeutic, Ampligen(R), as noted in a
peer-reviewed Journal of Immunology study and reported by Hemispherx on April
30, 2007, may be based on its binding to the human toll-like receptor 3 (TLR3)
and activating subsequent signaling cascades. Toll-like receptors such as TLR-3
serve as "pattern recognition" receptors in the early detection of pathogens and
the establishment of early defense mechanisms (innate immunity). As such, they
may be critical to the first line of immunological defense against a broad range
of pathogens, such as otherwise lethal viruses and various forms of cancer.
About Chronic Fatigue Syndrome
Chronic Fatigue Syndrome (CFS) has a top priority status at the Centers for
Disease Control and Prevention, the governmental agency responsible for disease
surveillance, as a serious and debilitating disease in the U.S. The disorder
reflects a major unmet medical need. There are currently no approved therapies
for CFS. The Agency for Research and Quality, a health service arm of the U.S.
Department of Health and Human Services, reported that Ampligen(R), an
experimental therapeutic, yielded the most promising clinical results to date
related to CFS. It should be noted that only federal regulatory agencies can
determine whether any experimental therapeutic is "safe and effective" for wider
distribution outside of the existing authorized clinical trials.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced 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) (FDA approved for a category of sexually transmitted diseases)
and the experimental therapeutics Ampligen(R) and Oragens(R). Ampligen(R) and
Oragens(R) represent experimental RNA nucleic acids being developed for globally
important debilitating diseases and disorders of the immune system. 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 patents comprising its core intellectual
property estate and a fully commercialized product (Alferon N Injection(R)). 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
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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