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) September 1,
2005 ( September 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
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(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.
On September 1, 2005, we posted on our website a letter to our Stockholders.
This letter is filed herewith as Exhibit 99.1.
Section 9 - Financial Statements and Exhibits Item 9.01
Financial Statements and Exhibits.
(c) Exhibits
The following Exhibit is filed as part of this report:
Exhibit No. Description
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99.1 Letter to Stockholders dated September 1, 2005
99.2 Press Release dated September 1, 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.
September 1, 2005 By: /s/William A Carter
-------------------------------
William A. Carter M.D., President
Exhibit 99.1
HEMISPHERX BIOPHARMA, INC.
September 1, 2005
Dear Stockholders,
The purpose of this letter is to provide an update to our Stockholders regarding
the status of the various endeavors that are currently being pursued by
Hemispherx. We are very excited about where the company stands today.
After many years of clinical testing, we are close to filing the New Drug
Application for our experimental drug Ampligen(R) to treat Chronic Fatigue
Syndrome. We feel very secure in the comprehensiveness of our data, which has
been compiled from our clinical trials involving over 700 participants.
We are currently accelerating the implementation of our manufacturing strategy
for Ampligen(R). The first part of the strategy consists of establishing
production of Ampligen(R) raw material, or polymer, in our own GMP facility in
New Brunswick, New Jersey, which was acquired in 2003 as part of our transaction
with Interferon Sciences, Inc. Creation of this polymer production capability
has been initiated and we expect to start equipment validation in New Brunswick
in late September.
The second part of the strategy involves the formation of a partnership with a
qualified contract manufacturer. We have identified several suitable
manufacturing partners this year and we are currently in the process of
selecting from the qualified candidates. One early candidate was Mayne
Pharmaceuticals, which had prior experience manufacturing Ampligen(R) in
Australia. Mayne is no longer a viable candidate since it is in the process of
terminating its contract manufacturing business. This termination will not have
an effect on our strategy or our timetable.
For the past 14 years Ampligen(R) has been successfully produced for our
clinical trials and for use in our Treatment IND program. The management team
responsible for that manufacturing remains in place and has been augmented by
the experienced GMP manufacturing team we acquired at the time of the Interferon
Sciences Inc. transaction. We are confident that our expanded manufacturing
management team will enable the successful production of Ampligen(R) in the
future. We have devoted and, assisted by the twenty million dollar equity credit
facility we recently established, will continue to devote substantial resources
to our manufacturing process and feel very strongly that it will be completed in
a timely and successful manner.
We are also very exited about the developments relating to the oral form of our
Alferon N product (Low Dose Oral Interferon Alfa-N3, Human Leukocyte Derived),
which is a new delivery form of our FDA approved drug, Alferon N. Alferon N is
the only natural interferon currently FDA approved and available in the
marketplace. We were pleased to announce last quarter that clinical trials in
human volunteers are being conducted in Philadelphia and that a clinical study
will shortly commence at the Princess Margaret Hospital in Hong Kong. We are
preparing more than 300,000 doses of Alferon LDO for appropriate clinical
programs. Pending the outcome of the ongoing clinical studies and based on
existing laboratory studies, we expect these trials to demonstrate that Alferon
LDO given orally can activate the relevant immune defense pathways in the human
body. This would potentially make Alferon LDO the first orally active interferon
drug candidate and would open an opportunity leading to a wide range of
potential new indications.
One such potential indication is Avian Flu. As widely covered in the media,
Avian Flu is a devastating and contagious disease. Health officials are
concerned that Avian Flu could mutate to a highly contagious form for humans.
This scenario is considered by experts in the field as highly probable. Should
this mutation occur it will be the genesis of the next pandemic and would render
vaccines presently under development ineffective. The threat of a highly lethal
pandemic has caused Governments around the world to search for a treatment that
they could potentially stockpile.
In another development Alferon N and Ampligen(R), experimental
immunotherapeutics, are among a small group of immunotherapeutic drugs being
considered by the department of defense to potentially combat dreaded viral
outbreaks including Avian influenza. The Department of Defense strategy will be
outlined in an upcoming article entitled "Innate Immunity for Biodefense: A
Strategy Whose Time Has Come" proposed for publication in Journal of Allergy and
Clinical Immunology (JACI). This article states that "Ampligen(R) has already
been tested against over 25 viruses and will be used in Advanced Biosystem's
proposal for inhaled IFN in conjunction with Alferon... No evidence of
inflammatory reactions has been observed in either Ampligen(R) or Alferon.
Administration of over 50,000 doses of Ampligen(R) has not resulted in a
cell-mediated autoimmune response. Alferon should be superior to single
recombinant IFN types with regards to binding to receptors that are structurally
altered by genetic polymorphisms" (emphasis added). This article, including the
innate immunity strategy for biodefense, is one of the independent endorsements
of our drug technology that energizes and encourages our present enthusiasm for
these products.
In closing, with the acceleration of our manufacturing strategy for Ampligen(R)
and our advancements in the development of the Low Dose Oral Interferon program,
we feel that the company is poised to make considerable progress toward bringing
the Hemispherx products to commercial success.
Sincerely,
/s/ William A. Carter
----------------------
William A. Carter, M.D.
Chairman and CEO
Information contained in this 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 letter
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 letter. 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
treatment indications.
Exhibit 99.2
HEMISPHERX BIOPHARMA, INC.
One Penn Center
1617 JFK Boulevard
Philadelphia, PA 19103
Phonee: (215) 988-0080
Fax: (215) 988-1739
Hemispherx Biopharma Expands Manufacturing Facility for Production of Ampligen
Status of clinical Trial advancements for Alferon LDO and manufacturing programs
updated in stockholder letter
Philadelphia, PA, September 1, 2005 - Hemispherx Biopharma, Inc. (AMEX: HEB)
discloses by letter to stockholders that it has increased the capacity of its
facility in New Brunswick, NJ to manufacture its experimental drug, Ampligen(R),
as well as advancements in the application of Alferon LDO for the potential
treatment of Avian Flu. The letter, which is being submitted as an 8-K with the
SEC, highlights several key developments currently underway.
Hemispherx is implementing a three-phase strategy in its manufacturing process
of Ampligen(R). The first component in this process highlighted in the
stockholder letter is the establishment of production of Ampligen(R)'s raw
material polymer in the Company's wholly owned New Brunswick, N.J. manufacturing
facility. The creation of the polymer production capability has been initiated
and Hemispherx expects to begin equipment validation in the facility in late
September.
The second strategic component involves the formation of a partnership with a
qualified contract manufacturer for finished product. The company is currently
in the process of selecting a qualified candidate from a pool of
already-identified and-pre-qualified contenders.
The third component of the manufacturing strategy is the development of the team
responsible for the production of Ampligen(R) in New Brunswick, N.J.. For the
past 14 years, Ampligen(R) has been successfully produced for clinical trials
and used for an ongoing Treatment IND program. The original management team
responsible for that manufacturing remains in tact and has been augmented by the
experienced GMP manufacturing team that was acquired with the Alferon-N
acquisition.
The developments of the Alferon Low Dose Oral (LDO) trials are also highlighted
in the stockholder letter. Clinical trials in human volunteers are underway in
Philadelphia and will also shortly commence at the Princess Margaret Hospital in
Hong Kong. Accordingly, there are currently more than 300,000 doses of Alferon
LDO being prepared for these clinical programs.
Pending the outcome of the ongoing clinical studies, and based on existing
laboratory studies, Hemispherx expects the trials may demonstrate that Alferon
LDO, given orally, can activate the relevant immune defense pathways in the
human body. This development would potentially make Alferon LDO the first orally
active interferon drug candidate and would open an invaluable opportunity for a
wide range of potential new indications. One such potential indication is for
treating Avian Flu. As widely covered in the media, Avian Flu is a devastating,
contagious disease. Worldwide health officials are concerned that Avian Flu
could mutate to a highly contagious form transferable to humans from animals.
This scenario is considered by experts in the field to be highly probable.
Should this mutation occur, it will be the genesis of the next global pandemic
and would render vaccines presently under development ineffective. The threat of
a highly lethal pandemic has caused governments around the world to search for a
treatment that they could potentially stockpile.
Consideration of Hemispherx's Alferon and Ampligen(R) therapeutics by the US
Department of Defense, in coordination with its Bio-defense strategy, is
featured in an upcoming article in the Journal of Allergy and Clinical
Immunology (JACI) as stated below:
The Department of Defense strategy will be outlined in an upcoming article
entitled "Innate Immunity for Biodefense: A Strategy Whose Time Has Come"
accepted for publication in the Journal of Allergy and Clinical Immunology
(JACI). This article states that "Ampligen(R) has already been tested against
over 25 viruses and will be used in Advanced Biosystem's proposal for inhaled
IFN in conjunction with Alferon.... No evidence of inflammatory reactions has
been observed in either Ampligen(R) or Alferon. Administration of over 50,000
doses of Ampligen(R) has not resulted in a cell-mediated autoimmune response.
Alferon should be superior to single recombinant IFN types with regards to
binding to receptors that are structurally altered by genetic polymorphisms."
HEMISPHERx CEO, Dr. William A. Carter concluded the stockholder letter, " With
the acceleration of our manufacturing strategy for Ampligen(R) and our
advancements in the development of the Low Dose Oral Interferon program, we feel
that the company is poised to make considerable progress toward bringing the
Hemispherx products to commercial success."
About Hemispherx Biopharma
Hemispherx Biopharma, based in Philadelphia, is a biopharmaceutical company
engaged in the manufacture and clinical development of new drug entities for
treatment of viral and immune-based chronic disorders. Hemispherx's flagship
products include Alferon and the experimental immunotherapeutics/antivirals
Ampligen(R) and Oragens(TM). Alferon is approved for a category of STD
infection, and Ampligen(R) and Oragens(TM) represent experimental nucleic acids
being developed for globally important chronic viral diseases and disorders of
the immune system including HPV, HIV, CFS, Hepatitis and SARS. Hemispherx's
platform technology includes large and small agent components for potential
treatment of various chronic viral infections. Hemispherx has in excess of 140
patents comprising its core intellectual property estate, a fully commercialized
product (Alferon N) and GMP certified manufacturing facilities for its novel
pharma product. 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) 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
treatment indications.
CONTACT: Investor Relations
Dianne Will (518) 398-6222
ir@hemispherx.net
www.hemispherx.net
Investor Contact:
Investor Relations Group
Erik Lux/ Adam Holdsworth/ John Nesbett
(212) 825-3210
Media Contact:
Investor Relations Group
Stephanie Schroeder
(212) 825-3210