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 4, 2007
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 1 - Registrant's business and operations
Item 1.02 Termination of material definitive agreement.
We notified Laboratorios Del Dr. Esteve, S.A. ("Esteve") of our intention to
terminate the license agreement that gives Esteve the right to market
Ampligen(R) for CFS in Spain, Portugal and Andorra. The basis of the termination
was non-performance by Esteve of certain contractually required clinical
trials. Negotiations were ongoing but amicable resolution could not be reached.
Esteve, as is its right under the license agreement, has filed for arbitration
seeking damages. We believe their claim is without merit and intend to
counterclaim, seeking damages.
For more information, please see the December 10, 2007 press release attached
hereto 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 December 10, 2007.
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.
December 10, 2007 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 INTENDS TO TERMINATE LICENSE TO ESTEVE FOR THE MARKETING OF
AMPIGEN(R) FOR CHRONIC FATIGUE SYNDROME (CFS) IN CERTAIN TERRITORIES
Company Expects to Regain Marketing Rights in Spain, Portugal and Andorra
Philadelphia, PA, December 10, 2007---Hemispherx Biopharma, Inc. (AMEX, HEB)
announced that it has notified Laboratorios Del Dr. Esteve, S.A. ("Esteve") of
its intention to terminate the license agreement that gives Esteve the right to
market Ampligen(R) for CFS in Spain, Portugal and Andorra. The basis of the
termination was non-performance by Esteve of certain contractually required
clinical trials. Negotiations were ongoing but amicable resolution could not be
reached.
As is its right under the license agreement, Esteve has applied for arbitration,
seeking damages. Hemispherx believes the Esteve claim is without merit and
intends to counterclaim, seeking damages.
About Hemispherx Biopharma Hemispherx Biopharma, Inc. is a 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) and the experimental therapeutics
Ampligen(R), Alferon LDO and Oragens(R). Alferon N Injection(R) is approved for
a category of STD infection, and Ampligen(R) and Oragens(R) represent a large
portfolio of experimental RNA nucleic acids being developed for globally
important viral diseases, severely debilitating disorders and biodefense
applications. 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 issued patents comprising
its core intellectual property estate, a fully commercialized product (Alferon N
Injection(R)) and a GMP certified manufacturing facility for its novel pharma
products. The Company is actively engaged in further expansion of its
intellectual property on a world wide basis to reflect the global distribution
of the various disorders which its platform technology addresses. 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), 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.