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)
February 19, 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 8 - Other Events
Item 8.01 Other Events.
We have been notified by the Food and Drug Administration indicating that the
originally scheduled Prescription Drug User Fee Act goal date of February 25,
2009 for our Ampligen(R) (Poly I Poly C12U) New Drug Application has be extended
by three months to May 25, 2009 "in order to provide time for a full review of
the submission." Please see the February 18, 2009 press release filed as an
exhibit hereto for more information.
Item 9.01. Financial Statements and Exhibits.
(c) Exhibits:
99.1 Press Release dated February 18, 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.
February 19, 2009 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
FDA EXTENDS HEMISPHERX'S NDA REVIEW DATE FOR AMPLIGEN(R)AS
POTENTIAL TREATMENT FOR CFS
Extended User Fee Goal is now May 25, 2009
Philadelphia, PA, February 18, 2009 - Hemispherx Biopharma, Inc. (AMEX - HEB)
has received a letter from the Food and Drug Agency ("FDA") indicating that the
originally scheduled Prescription Drug User Fee Act ("PDUFA") date on the
Ampligen(R) (Poly I:Poly C12U) New Drug Application (NDA) would be extended by
three months "in order to provide time for a full review of the submission."
Additional data were received by the FDA within 3 months of the user fee goal
date.
Due to constraints at the FDA, specifically and including the increased workload
related to the recently enacted and implemented FDA Amendments Act ( "FDAAA")
and FDA's Safety First/Safe Use initiatives, work priorities may change
resulting in the Agency going past the customary PDUFA goal set for reviews of
an application.
A decision was originally expected by February 25, 2009, for the Company's
submission of its Ampligen(R) NDA, which is designated as an Orphan Drug for the
treatment of Chronic Fatigue Syndrome, which has no FDA approved treatments on
the market. Ampligen(R) is also authorized for Emergency (compassionate) Cost
Recovery Sales Authorization by the FDA and has a "promising" designation by the
Agency on Health Research Quality (AHRQ): "Ampligen(R), an investigational drug
that is not approved by the FDA, given intravenously to severely debilitated
patients, yielded the most promising results." The extended user fee goal date
is now May 25th, 2009.
Extensions of NDA reviews are a separate category of FDA response, distinct from
a complete response letter or approval by the PDUFA date, and have always
existed. Prior to the recent new FDA initiatives (cited above) and resultant
increased workload, "on time" action by the Agency has generally ranged between
68 and 100 percent for the standard NDA reviews between FY 1999 and FY 2006
(source: Annual FDA PDUFA Performance Reports (www.FDA.gov ).
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(R) 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.