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.
January 3, 2006 By: /s/ William A. Carter
William A. Carter M.D., President
January 3, 2006
2005 has been an excellent year for Hemispherx. Years of research, development,
clinical trials and perseverance have led to growing recognition of the value of
our scientific approach and product portfolio and have facilitated important
collaborations, acquisitions and financings, all key steps on the path to
successful commercialization. Our strategy going forward is to focus all efforts
on regulatory approval and advantageous alliances, with the ultimate goal being
increased shareholder value. Every clinical trial initiated, alliance struck and
investment made in the past year was undertaken with these objectives in mind.
We have enhanced our asset base and enriched our professional resources to
provide us with the resources, relationships and expertise to achieve our
The twenty million dollar equity credit line established with Fusion Capital has
provided us the means to build out our manufacturing capability, strengthen our
balance sheet and secure future growth with minimum dilution to our
The expansion of our manufacturing facilities and staff in New Brunswick, New
Jersey and the collaborative manufacturing relationship with HollisterStier
Laboratories LLC for the production of Ampligen(R) are both ahead of schedule
and due for completion and certification late in the 2nd quarter 2006. These
efforts will significantly add to our production capacity and conclude the last
steps necessary for the filing of a consolidated NDA for Ampligen(R) for the
treatment of CFS.
The single shortfall of our 2005 objectives was the delay in the filing of our
NDA for Ampligen(R) for the treatment of CFS. Our targeted filing by 2005
year-end was based on an anticipated grant of FDA permission to submit a rolling
or staged NDA application, which would allow us to file the safety and clinical
sections of the NDA application in advance of the manufacturing section. Even
though FDA permission to submit a rolling or staged NDA application has yet to
be received, since we are scheduled to complete our manufacturing certifications
late in the 2nd quarter of 2006, we should, in any event, file our NDA for
Ampligen(R) for the treatment of CFS no later than the first part of the 3rd
quarter of 2006.
The disturbing threats of an influenza pandemic and bio-terror attacks have
pushed researchers and government institutions to pursue creative alternatives
to established vaccines and antivirals. This pursuit has led to a growing
recognition of the value of our scientific approach and product portfolio as
investigators have identified Hemispherx products as potentially adequate
options as a broad-spectrum, first line of defense approach to combat deadly
pathogens, such as the H5N1 influenza virus. Investigators, with whom we are now
collaborating, have sought and are utilizing Hemispherx products in ongoing
clinical trials in this vital area.
Our clinical trials and those of our collaborators in the United States, Canada,
Hong Kong and Japan, if successful, will allow for NDA filings of our drugs as
experimental stand-alone antivirals or as adjuvants (boosters) under the
proposed new emergency guidelines whereby drugs may be licensed for sale based
on successful studies in two recognized animal models. While we are committed to
and are actively pursuing commercial approval of Ampligen(R) for the treatment
of CFS, we are aware of, and believe we are uniquely positioned to take
advantage of, the fact that the avian flu (prevention / treatment) market
opportunity is far larger at present, rapidly growing and encompasses areas of
the market opportunity (Europe and Asia) where CFS recognition and treatment is
still in its infancy.
Our strategy now is to obtain regulatory approval and to leverage our laboratory
successes in aggressively pursuing advantageous relationships. We are committed
to these objectives and determined to deliver. The next two years will be
significant in Hemispherx's transition to a developer, manufacturer and
distributor of value-added immune enhancing drugs.
At the Biodefense Research Meeting sponsored by the American Society of
Microbiology in February 2006 (Washington, DC) we will unveil exciting new
results in both the avian flu vaccine augmentation and the potential
broad-spectrum antiviral activities of Alferon N(TM) and Ampligen(R). Mark these
dates on your calendar as important milestones for our Company.
It is critical to our success that our investors understand the path that we are
taking and our progress down this path. In an effort to improve upon
communication to the investor community we will commence quarterly investor
conference calls in line with the filing of the first 10Q of 2006.
We thank you for your on-going support.
/s/ William A. Carter
Dr. William Carter
Chairman and Chief Executive Officer
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) and Oragens(TM)) 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(R) do not imply
that the product will ever be specifically approved commercially for these other