8-K 1 r8kestv.txt 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.