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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 1, 2009
HEMISPHERX BIOPHARMA, INC.
(Exact Name of Registrant as Specified in Charter)
Delaware 0-27072 52-0845822
(State or Other Jurisdiction (Commission (IRS Employer
of Incorporation) File Number) Identification No.)
1617 JFK Boulevard, Philadelphia, Pennsylvania, 19103
(Address of Principal Executive Offices, including Zip Code)
Registrant's telephone number, including area code: (215) 988-0080
Not Applicable
(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))
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Item 8.01 Other Events.
On December 1, 2009, the Company issued a press release announcing its receipt
of a Complete Response Letter from the Food and Drug Administration on its New
Drug Application for Ampligen(R).
A copy of the press release, dated December 1, 2009, is attached as Exhibit 99.1
to this Current Report on Form 8-K and is incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. Description
99.1 Press Release dated December 1, 2009 regarding
receipt of a Complete Response Letterfrom the Food
and Drug Administration.
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, as
amended, the registrant has caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Date: December 1, 2009
HEMISPHERX BIOPHARMA, INC.
/s/ William A. Carter
____________________________
William A. Carter, M.D.,
Chief Executive Officer
Exhibit 99.1
Company/Investor Contact:
Dianne Will
Hemispherx Biopharma, Inc.
518-398-6222
ir@hemispherx.net
Hemispherx Biopharma Receives Complete Response Letter from FDA on
Ampligen(R) New Drug Application for Chronic Fatigue Syndrome
...Outlines Additional Recommendations
Philadelphia, PA - December 1, 2009 - Hemispherx Biopharma, Inc. (NYSE Amex:
HEB) (the "Company" or "Hemispherx"), announced that it received a Complete
Response Letter from the US Food and Drug Administration ("FDA") which describes
specific additional recommendations related to the Ampligen(R) NDA. In
accordance with its 2008 "Complete Response" procedure, the FDA reviewers
determined that they cannot approve the application in its present form and
provided specific recommendations to address the outstanding issues. Hemispherx
is carefully reviewing the Complete Response letter and will seek an expedited
meeting with the FDA to discuss its recommendations. Management is pleased to
have received specific advice on the remaining issues and is looking forward to
making a thorough but expedited response its top priority, and plans to take all
appropriate steps to seek approval and commercialization of Ampligen(R).
Most notably, the FDA stated that the two primary clinical studies submitted
with the NDA did not provide credible evidence of efficacy of Ampligen(R) and
recommends at least one additional clinical study which shows a convincing
effect and confirms safety in the target population. The FDA indicated that the
additional study should be of sufficient size and sufficient duration (6 months)
and include appropriate monitoring to rule out the generation of autoimmune
disease. In addition, patients in the study should be on more than one dose
regimen, including at least 300 patients on dose regimens intended for
marketing. Finally, the additional study must incorporate both a well-controlled
QT interval study and pharmacokinetic evaluations.
Other items required by the FDA include certain aspects of Non-Clinical safety
assessment, and Product Quality. In the Non-Clinical area, the FDA is
recommending that the Company complete rodent carcinogenicity studies in two
species. As part of the NDA submission, the Company had requested that these
studies be waived, but the waiver has not been granted. Certain additional
non-clinical studies and additional data to support non-clinical studies already
submitted with the NDA are also recommended by the FDA. Prior to the receipt of
the Complete Response letter, the Company had already begun many of these
additional studies and the collection of the requested additional data.
Under the Product Quality section of the Complete Response letter, the FDA
recommends that the Company submit additional data and complete various
analytical procedures. The collection of these data and the completion of these
procedures is already part of the Company's ongoing Quality Control, Quality
Assurance program for Ampligen(R) manufacturing under cGMP (current Good
Manufacturing Practice Guidelines) and the manufacturing enhancement program
recently undertaken by the Company and announced in a news release on September
16, 2009.
Finally, the FDA commented on Ampligen(R) manufacturing noting the need to
resolve outstanding inspection issues at the facilities producing Ampligen(R).
These include the Company facility located in New Brunswick, NJ and one of the
Company's third party manufacturing facilities (Hollister-Stier Laboratories).
The Company has been working to resolve these issues.
At this time the Company's management has not determined the impact of the
additional recommendations set forth in the Complete Response letter on the
timelines and overall cost of the Ampligen(R) program, but the Company's
management has made response to the issues and satisfaction of any additional
requirements a top priority. The Company will seek to meet with the FDA to
clarify any issues identified in the Complete Response letter and to work with
the FDA to identify the most expeditious path to satisfaction of the
requirements for approval of the Ampligen(R) NDA.
About Hemispherx Biopharma
Chronic Fatigue Syndrome is an enigmatic, profoundly debilitating and
potentially life-threatening disease with which a new retrovirus was recently
associated. Researchers are investigating the possible role of this virus in the
symptomatology of the disease.
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical 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) Oragens(R),
and Alferon LDO. 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 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 completion of the NDA filing process with
Ampligen(R) and the receipt of a Complete Response Letter from the FDA do not
imply that the Company will be able to successfully comply with any or all of
the requirements requested in that Letter or that the product will ever be
approved for commercial sale. In addition, 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(R)) 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.