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)
March 6, 2008
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.
Following our submission of a clarifying amendment on January 9, 2008, to our
NDA application and a subsequent face-to-face meeting with the Agency, the
number of items necessary to accomplish a complete NDA for filing purposes has
been reduced from an original fourteen (14) to five (5). Specifically, for NDA
filing purposes, 9/14 of the original incomplete items noted in the FDA letter
received December 5, 2007 are no longer considered filing - related issues. The
remaining open items are being promptly addressed by us thru a series of five
(5) additional Amendments to the NDA.
For more information, please see the March 6, 2008 press release attached hereti
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 March 6, 2008
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.
March 10, 2008 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 REACHES AGREEMENT WITH FDA ON SPECIFIC STEPS TO ACHIEVE
COMPLETE NDA ON PROPOSED CFS TREATMENT
... No Additional Studies Indicated
Philadelphia, PA, March 6, 2008---Hemispherx Biopharma, Inc. (AMEX, HEB)
announced today that, following its submission of a clarifying amendment on
January 9, 2008, to its NDA application and a subsequent face-to-face meeting
with the Agency, the number of items necessary to accomplish a complete NDA for
filing purposes has been reduced from an original fourteen (14) to five (5).
Specifically, for NDA filing purposes, 9/14 of the original incomplete items
noted in FDA letter received December 5, 2007 are no longer considered filing -
related issues. The remaining open items are being promptly addressed by the
Company thru a series of five (5) additional Amendments to its NDA as described
below.
Specifically, the open items-requisite for a complete NDA filing status - may be
grouped into one of two categories: Category (1) Administrative items (four)
include: (a) transfers of additional clinical records (termed "CRF's"), (b)
transfer of several documents previously submitted to the FDA, (c) additional
clinical data reconciliations (compiled from the CRF records) and (d) additional
computer generated charts which summarize specific parts of the CRFs. Transfer
of these records will thereby allow the Agency reviewers to evaluate
independently the statistical efficacy /safety conclusions of the Company's
existing NDA. Category (2) (One item): a reformatting and enlarged analysis of
the existing pharmacokinetics ("PK") report to more closely align with current
International Committee on Harmonization ("ICH") guidelines.
Importantly, the company believes no further studies are required to achieve a
complete NDA filing status for purposes of regulatory review of the entire
document.
As part of the agreement reached with the Agency, the additional files/data may
be submitted sequentially as separate NDA Amendments to the existing NDA to
accelerate the review process. Submission of these Amendments to the FDA is
expected to begin this week with all Amendments expected to be completed and
filed shortly. A collaboration with Octagon Research Solutions, a major provider
of electronic filings of regulatory documents, will facilitate and accelerate
the overall filing process. These Amendments will add to the overall data base
of the existing NDA (submitted October 10, 2007) and the company's
pre-submission of non-clinical information (submitted December 29, 2006), which
was assigned the original NDA number.
While the company is optimistic as to the progress of the NDA filing, there are
no assurances that the FDA will accept the amended NDA for review, and if
accepted there are no assurances that the NDA will be approved.
About CFS and Ampligen(R)(poly I: Poly C12U), an Experimental Therapeutic
A recent independent study enumerated three primary causes of early death in CFS
populations at large (without administration of Ampligen(R)) that may be
attributable to the disease: 1) cardiovascular events, 2) suicide and 3)
untreatable life-threatening malignancies/tumors. Within the NDA, Hemispherx
addresses how Ampligen(R), an experimental therapeutic, may address these and
other high risk aspects of CFS.
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 more than 90,000 dose administrations. The experimental
therapeutic was originally discovered and developed at The Johns Hopkins
University and thereafter licensed to Hemispherx.
Chronic Fatigue Syndrome (CFS) has a top priority status at the Centers for
Disease Control and Prevention ("CDC"), 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. Only regulatory agencies can determine whether any experimental
therapeutic, including Poly I: Poly C12U (Ampligen(R)) is "safe and effective."
At this time, Ampligen(R), an experimental therapeutic, is only available in
specific clinical trial settings conducted under specific governmental
authorizations. It has not been determined to be "safe and effective" by any
governmental body. Ampligen(R) represents an entirely new class of RNA-based
drug therapies. The Company's prompt response to the questions posed by the FDA
was made possible by the broad-based team of clinical and scientific experts
assembled during 2007, with experience in successful global development of NDAs
for new molecular entities ("NMEs"), such as Ampligen(R).
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 90 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
Contact:
Hemispherx Biopharma, Inc.
Dianne Will, Investor Relations
(518) 398-6222, Fax: (618) 398-6369
HEB's Web Site: 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.