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 4, 2005 ( February 1, 2005)
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
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Item 8.01 Other Events.
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On February 1, 2005, we sent a letter to our Shareholders. This letter is filed
herewith as Exhibit 99.1.
Section 9 - Financial Statements and Exhibits
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Item 9.01 Financial Statements andExhibits.
(c) Exhibits
The following Exhibit is filed as part of this report:
Exhibit No. Description
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99.1 Letter to Shareholders dated January 26, 2005
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 4, 2005 By:/s/William A Carter
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William A. Carter M.D., President
Exhibit 99.1
HEMISPHERX BIOPHARMA, INC.
January 26, 2005
Dear Fellow Shareholders,
As 2005 begins and management takes a look back at the company's
achievements during the past year, it is evident that we accomplished a great
deal and that the company is positioned to succeed. There is much for us to look
forward to in the coming year. Multiple events took place in this past year that
have laid the groundwork for years to come and will allow us to capitalize on
the hard work that the company has already undertaken.
Management would now like to help our fellow shareholders understand
Hemispherx current status, our vision for tomorrow and how we plan to build for
a profitable future.
Culminating many years of research and testing, in October 2004,
Hemispherx successfully completed the phase III clinical trial of its drug
Ampligen(R) for the treatment of Chronic Fatigue Syndrome (CFS). As most of you
are aware, CFS is a debilitating disease that, according to the Center for
Disease Control, affects between 400,000 and 800,000 people in the United States
alone, with total annual value of lost productivity, excluding the costs for
healthcare, estimated at $9.1 billion. Currently there is no approved treatment
for CFS, and Ampligen(R) is the only drug in this late stage of the approval
process for this disease. Given these circumstances, it is apparent that the
opportunity before us is considerable. Today, the management team is focused on,
and giving priority to, preparing the final new drug application (NDA) to be
filed with the Food and Drug Administration(FDA).
At this point it is crucial that we be meticulous in the preparation of
our NDA filing so that we may clear this final hurdle in the approval process.
While the NDA filing process certainly has many concrete requisite steps, it is
truly an organic process requiring skill and good judgment to successfully
complete. Our clinical research monitors and clinical research assistants have
already visited all of the multiple clinical study sites around the country and
have collected all of the appropriate data generated at each of the clinical
study sites. The data must be reviewed and checked for gaps, inconsistencies and
inaccuracies, which, due to the human factor, occur in all clinical trials.
Gaps, inconsistencies and inaccuracies in the data must be resolved with the
respective clinical investigators, all while maintaining a clear trail and
record of events which permits the FDA and other international regulatory
agencies to conduct a meaningful audit and confirmation of these events. To
accelerate and optimize the accuracy of this process, management increased the
company's staff by employing additional medical doctors, a PhD and other highly
trained individuals. We are pleased to report to shareholders that we have
completed this step in the process.
We are now moving forward with the intricate and time consuming phase
of having the data put into proper format, having an independent statistical
analysis of the data performed and preparation of a narrative report for the
clinical study. In addition to our increased staff, to assist us with this next
phase the company plans to contract with Octagon, a company with known expertise
and a proven track record of success in assisting companies in the completion
and electronic filing of NDAs. Needless to say the company has and will continue
to diligently pursue the successful completion of the NDA filing process and is
looking forward to moving on to the rewarding next phase of marketing
Ampligen(R) and providing a much needed treatment for patients suffering from
CFS.
As previously reported, in March 2004 we diversified our product
portfolio by finalizing the acquisition of the worldwide rights to the
Alferon(R) program, which include Alferon N Injection(R), a natural interferon
approved by the FDA for treatment of Human Papilloma Virus (HPV), and Alferon(R)
LDO, an experimental low dose, oral form of natural interferon. The company's
Alferon N Injection(R) product continues to demonstrate superior efficacy as
well as an outstanding safety profile in its FDA approved indication in HPV.
Alferon N Injection(R) is the only natural interferon available to treat HPV
and, because of the higher recurrence rates of HPV with medications other than
Alferon N Injection(R), we are confident it is the most effective treatment in
the marketplace and provides us with an excellent marketing opportunity. To reap
this opportunity our challenge is to educate physicians with respect to Alferon
N Injection(R) being the most effective treatment for HPV. During the last
quarter of 2004 we implemented a multi-faceted program to convey this message to
physicians and anticipate increasing sales with the increasing awareness of
physicians. Your management has also undertaken to leverage the potency and
safety of this outstanding product in two ways: first, identifying new
therapeutic indications which take advantage of its superior efficacy and
safety, and secondly devising new drug delivery formats which are leveraged out
of the outstanding potency and safety of the natural Alferon(R) cocktail.
At the time of the Alferon(R) program acquisition we also acquired
an FDA approved 44,000 square foot manufacturing facility and office spaces in
New Brunswick, New Jersey. In addition to its significant value to the company
as a manufacturing facility, currently for our Alferon N Injection(R) and
Alferon(R) LDO and potentially for Ampligen(R) components, the New Brunswick
facility is allowing us to gain both efficiency and economy of operation by
moving our quality control operation from the leased Rockville, Maryland
location to the wholly owned New Brunswick facility. The move of the quality
control operation to the New Brunswick facility is underway and should be
completed during the first quarter of this year.
Throughout the year we have reported on the initiation and progress of
other trials involving our Ampligen(R) and Alferon(R) products. Because of the
nature of our products which stimulate and modulate the human bodies own immune
system we believe they will be effective in a number of diseases and should be
clinically tested in a number of disease indications. To achieve broad testing
of our patented drug technologies while conserving our resources to permit focus
upon completion of the phase III clinical trial of Ampligen(R) for the treatment
of CFS and the NDA filing, we have partnered with others, under our direction,
to conduct these promising trials. Laboratorios del Dr. Esteve, S.A., pursuant
to a distribution and partnering agreement with us, is now conducting in Spain
an FDA compliant Phase IIb clinical trial studying Ampligen(R) in the treatment
of patients co-infected with HIV and HCV. Dr. James Rahal., former president of
the New York State Society of Infectious Diseases, in association with us, is
conducting a multi-site phase III clinical trial studying Alferon N Injection(R)
in the treatment of patients with West Nile Virus. In collaboration with
Vanderbilt University and the Princess Margaret Hospital in Hong Kong, China, a
clinical trial is being conducted studying Alferon(R) LDO in patients with SARS
and other sudden onset viruses.
Under the direction of Dr. Luc Montagnier, the discoverer of the
human immunodeficiency virus (HIV) and a member of the Hemispherx Scientific
Advisory Board, the World Foundation AIDS Research and Prevention, in
collaboration with the company, attempted initiation of a Phase II clinical
trial in Ivory Coast, Africa utilizing Alferon(R) LDO in the treatment of
patients with HIV. As Alferon(R) LDO is administered orally and has relatively
low cost, the conduct of this trial in Africa, with its high HIV infection rates
and relatively poor economies, is particularly apt. However, due to the
political unrest in Ivory Coast, conditions there for conduct of the trial have
proved unmanageable and a new location in Africa is being identified, with
implementation of this important trial expected to begin shortly. Our clinical
investigators continue to enroll patients in our promising clinical trial (AMP
720) studying Ampligen(R) in patients with HIV who are on the HART STI regimen.
Having completed our Ampligen(R) CFS Phase III clinical trial in October 2004,
we are seeking to add new clinical investigators to the AMP 720 clinical trial.
Additionally we are surveying appropriate partners to undertake, under our
direction, a Phase IIb clinical study pursuant to our FDA approved protocol
utilizing Alferon N Injection(R) in the treatment of patients with multiple
sclerosis.
Recently the company was compelled to initiate two complaints in
federal court against certain individuals and entities for illegal actions
damaging to the company and the company's shareholders. Both complaints allege
that another entity made overtures to Hemispherx seeking a merger; that
Hemispherx undertook appropriate due diligence and in each case determined that
merger would not be in the best interest of Hemispherx and its shareholder, as
each of these companies, in the judgment of Hemispherx' Board of Directors,
substantially overvalued its assets and/or exhibited various technological
deficiencies; that these entities and major shareholders of these entities, upon
being informed of Hemispherx' non interest in merger, in order to save their
respective enterprises and investments, undertook and are undertaking illegal
acts in an effort to gain control of Hemispherx and, through Hemispherx, save
their respective companies and investments. We believe that in each instance the
illegal actions emanated from Belgian sources. The company regrets the
occurrence of these illegal actions necessitating the litigation. Through the
litigation the company is taking, and will continue to take, appropriate, firm
action against those seeking, through illegal actions, to damage the company and
its shareholders. At the same time management will not allow these illegal
actions to divert the company from diligent pursuit of its business goals,
including the preparation and filing of the NDA for Ampligen(R) for the
treatment of CFS.
Significantly validating and recognizing, we believe, the strength
of our intellectual property and its value, on November 30, 2004 the company
received an invitation from the Department of Defense inviting the company to
submit a proposal for a collaborative undertaking with the Department of Defense
with regard to the company's drug technology which stimulates the human bodies
"innate immunity", which is defined as its ability to withstand a broad spectrum
of viruses and noxious agents.
Interferon/Ampligen(R) is considered a major component which triggers the
human bodies "innate immunity". There are very few, if any, competing products
which have been clinically studied which trigger the human bodies "innate
immunity". We have, in concert with Vanderbilt University, now submitted three
proposals in response to the invitation, one for Alferon(R) LDO, one for an oral
form of Ampligen(R) and one for Oragens. Obviously we are excited about this
potential to work with the Department of Defense in the further development of
our drug technology and the valuable market opportunities which accompany it.
Our overall vision has remained the fulfillment of needs of the
marketplace in areas that will provide excellent returns on our investments by
serving large and untapped markets. Through our extensive patent portfolio,
attention to large and underserved markets, a positive cash position and recent
acquisitions, Hemispherx is uniquely positioned to become a major player in the
pharmaceutical marketplace. With many programs in place, the year 2005 holds
great promise. The company's strong infrastructure places us in an enviable
position.
Sincerely,
/s/ William A. Carter
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William A. Carter
Chairman of the Board & CEO
[GRAPHIC OMITTED][GRAPHIC OMITTED]
Hemispherx New Brunswick Manufacturing Facility
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Information contained in this shareholder letter 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 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. Only Clinical Studies under well-controlled conditions can establish
efficacy and safety of any product. 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 treatment
indications.