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)
May 22, 2009
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 7 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On May 26, 2009, we issued a press release, in which we announced that the U.S.
Food and Drug Administration has advised the Company that it may require up to
1-2 additional weeks to take action beyond the scheduled Prescription Drug User
Fee Act action date of May 26, 2009 on the New Drug Application for
Ampligen(R)(Poly I POly C12U), a selective TLR3 modulator, for the management of
Chronic Fatigue Syndrome. The text of this press release is set forth as Exhibit
99.1
In accordance with the general instructions B.6 of form 8-K, the information in
this report, including Exhibit 99.1, is furnished and shall not be deemed
"filed" for the purposes of section 18 of the Securities Exchange Act of 1934,
as amended (the "Exchange Act"), or otherwise subject to the liability of that
section, or incorporated by reference in any filing under the Securities Act of
1933, as amended, or the Exchange Act, except as shall be expressly set forth by
specific references in such filing.
Item 9.01. Financial Statements and Exhibits.
(c) Exhibits:
99.1 Press Release dated May 26, 2009.
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.
May 26, 2009 By: /s/ William A. Carter
---------------------
William A. Carter M.D.,
Chief Executive Officer
Exhibit 99.1
Company/Investor Contact:
Dianne Will Mark Collinson
Hemispherx Biopharma, Inc. CCG Investor Relations
518-398-6222 310-477-9800
ir@hemispherx.net
HEMISPHERX BIOPHARMA ANNOUNCES POSSIBLE BRIEF DELAY IN FDA ACTION ON AMPLIGEN(R)
NEW DRUG APPLICATION
Philadelphia, PA, May 26, 2009 - Hemispherx Biopharma, Inc. (NYSE/AMEX -HEB)
today announced that the U.S. Food and Drug administration ("FDA") has advised
the company that it may require up to 1-2 additional weeks to take action beyond
the scheduled Prescription Drug User Fee Act action date of May 25, 2009 on the
New Drug Application for Ampligen(R) (Poly I Poly C12U), a selective TLR3
modulator, for the management of Chronic Fatigue Syndrome. Reason for the
possible delay was attributed by the Agency to certain staff scheduling changes
which might (or might not) delay the report. Accordingly the Company's
development plan for Ampligen(R) continues as described in the recently filed
10Q and 10K, as the FDA did not request additional information from the Company
at this time.
About Hemispherx Biopharma Hemispherx Biopharma, Inc. is a specialty pharma
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 50 issued 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; Similarly, the completion of
NDA filing process with Ampligen(R) does not imply that the product will ever be
approved commercially. # # #