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)
December 3, 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 December 3, 2007 we received notice from the U.S. Food and Drug
Administration (FDA) that our NDA submission for Ampligen(R) in Chronic Fatigue
Syndrome (CFS) had been determined to be insufficiently complete to permit a
substantive review under 21 CFR 314.101 (d). Specifically eleven deficiencies
were noted in the Clinical Section and three in the Pre-Clinical Section. No
deficiencies were cited in the Chemistry, Manufacturing and Controls Section
(CMC).
We believe that several factors may influence the pace of the regulatory path:
(1) Ampligen(R) (Poly I : Poly C12U) has a relatively long regulatory history
(approximately twenty years) and regulatory guidelines suggest that longer
clinical development histories may require more review; (2) Ampligen(R) is also
the first drug of its class to apply for NDA review status; and (3) in some
circumstances, clinical data reporting guidelines have changed since the initial
studies on Ampligen(R), an experimental therapeutic, were executed in the late
1980s and early 1990s.
The Company will respond promptly in writing to all of the filing issues raised
by the FDA and will request a guidance meeting to clarify any items outstanding.
For more information, please see the December 7, 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 December 7, 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.
December 7, 2007 By: /s/ William A. Carter
--------------------------
William A. Carter M.D.,
Chief Executive Officer
Exhibit 99.1
Company/Investor Contact:
Dianne Will Sean Collins, Sr. Partner
Hemispherx Biopharma, Inc. CCG Investor Relations
518-398-6222 310-477-9800
ir@hemispherx.net
HEMISPHERX BIOPHARMA RECEIVES NOTICE OF
INCOMPLETE NEW DRUG APPLICATION (NDA)
Company Expects to Respond Promptly while Moving Forward
on Planned Filings outside the US
Philadelphia, PA, December 7, 2007---Hemispherx Biopharma, Inc. (AMEX, HEB)
announced that it has received notice from the U.S. Food and Drug Administration
(FDA) that its NDA submission for Ampligen(R) in Chronic Fatigue Syndrome (CFS),
after preliminary review, had been determined to be insufficiently complete to
permit a substantive review under 21 CFR 314.101 (d). Specifically eleven
deficiencies were noted in the Clinical Section and three in the Pre-Clinical
Section. No deficiencies were cited in the Chemistry, Manufacturing and Controls
Section (CMC).
Hemispherx believes several factors may influence the pace of the regulatory
path: (1) Ampligen(R) (Poly I : Poly C12U) has a relatively long regulatory
history (approximately twenty years) and regulatory guidelines suggest that
longer clinical development histories may require more review; (2) Ampligen(R)
is also the first drug of its class to apply for NDA review status; and (3) in
some circumstances, clinical data reporting guidelines have changed since the
initial studies on Ampligen(R), an experimental therapeutic, were executed in
the late 1980s and early 1990s.
The Company will respond promptly in writing to all of the filing issues raised
by the FDA and will request a guidance meeting to clarify any items outstanding.
In October, 2007, the Company's New Brunswick facility passed a biannual FDA
inspection relating to its fully commercialized interferon product (Alferon N
Injection) with no infractions or citations.
The Company will continue to move forward, as originally planned, with its
regulatory filings in various countries outside the United States, while
continuing its efforts to meet all the FDA requirements. The NDA filing rate
does not affect ongoing vaccine enhancement programs with Ampligen(R), an
experimental TLR3 agonist, or ongoing Treatment IND programs for CFS in the U.S.
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 90 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.