-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, RfTMGajKf/C7IB2RKRvojf3cBxbSuEmBVPMgaZ2qnl5MaVqGGDEoFvyR87w0DU9Z HKB6EvQ+UMxe29wYmbxFWg== 0001157523-08-000032.txt : 20080103 0001157523-08-000032.hdr.sgml : 20080103 20080103071535 ACCESSION NUMBER: 0001157523-08-000032 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080103 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080103 DATE AS OF CHANGE: 20080103 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ANTIGENICS INC /DE/ CENTRAL INDEX KEY: 0001098972 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 061562417 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-29089 FILM NUMBER: 08503713 BUSINESS ADDRESS: STREET 1: 630 FIFTH AVENUE SUITE 2100 CITY: NEW YORK STATE: NY ZIP: 10111 BUSINESS PHONE: 212-994-8200 MAIL ADDRESS: STREET 1: 630 FIFTH AVENUE SUITE 2100 CITY: NEW YORK STATE: NY ZIP: 10111 8-K 1 a5576725.txt ANTIGENICS, INC. 8-K 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 January 3, 2008 Date of Report (Date of earliest event reported) - -------------------------------------------------------------------------------- ANTIGENICS INC. (Exact name of registrant as specified in its charter) - -------------------------------------------------------------------------------- DELAWARE 000-29089 06-1562417 (State or other jurisdiction (Commission (IRS Employer of incorporation) File Number) Identification No.) 162 Fifth Avenue, Suite 900 New York, NY 10010 (Address of principal executive offices) (Zip Code) 212-994-8200 (Registrant's telephone number, including area code) - -------------------------------------------------------------------------------- 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)) Item 8.01 Other Events On January 3, 2008, Antigenics Inc. announced that Acambis has released results from a Phase 1 study of its ACAM-FLU-A(TM) vaccine, which contains Antigenics' QS-21 Stimulon(R) adjuvant. Overall, the trial results demonstrated that ACAM-FLU-A was well tolerated and capable of stimulating an immune response. Although immune responses were observed in all groups that received vaccine, the highest immune response was observed in the group vaccinated with ACAM-FLU-A plus QS-21 adjuvant. In this group, 90 percent of subjects generated virus-specific antibodies following immunization. Based on these results, Acambis exercised its option for a commercial license to QS-21. Under the terms of the agreement, Antigenics is entitled to receive future milestone payments and product royalties in the event of successful development and commercialization of ACAM-FLU-A. The full text of the press release issued in connection with the announcement is being furnished as Exhibit 99.1 to this current report on Form 8-K. Item 9.01 Financial Statements and Exhibits (d) Exhibits The following exhibit is furnished herewith: 99.1 Press Release dated January 3, 2008 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. ANTIGENICS INC. Date: January 3, 2008 By: /s/ Garo H. Armen ------------------------ Garo H. Armen, Ph.D. Chairman and Chief Executive Officer EXHIBIT INDEX Exhibit No. Description of Exhibit - ----------- ---------------------- 99.1 Press Release dated January 3, 2008 EX-99..1 2 a5576725ex99_1.txt EXHIBIT 99.1 Exhibit 99.1 Antigenics Reports Positive Data on QS-21 Stimulon(R) Adjuvant in Acambis' Influenza A Vaccine NEW YORK--(BUSINESS WIRE)--Jan. 3, 2008--Antigenics Inc. (NASDAQ: AGEN) today announced that Acambis (LSE: ACM) has released results from a Phase 1 study of its ACAM-FLU-A(TM) vaccine, which contains Antigenics' QS-21 Stimulon(R) adjuvant. Based on these results, Acambis exercised its option for a commercial license to QS-21. Under the terms of the agreement, Antigenics is entitled to receive future milestone payments and product royalties in the event of successful development and commercialization of ACAM-FLU-A. QS-21 is an investigational adjuvant, which is a substance added to vaccines and other immunotherapies that is designed to enhance the body's immune response to the antigen contained within the treatment. Influenza is a major global threat. According to the World Health Organization, between 250,000 to 500,000 related deaths occur annually. Currently, seasonal influenza vaccines are reformulated each year to address viral mutations. ACAM-FLU-A targets M2e, a conserved region of influenza A strains, which could potentially overcome the need for annual reformulations. Since all identified pandemic influenza strains are type A, ACAM-FLU-A could potentially be used to protect against pandemics of influenza as well. Study Findings The Phase 1 trial of ACAM-FLU-A evaluated the vaccine's safety and ability to generate an immune response among vaccinated subjects. The randomized, double-blind, placebo-controlled trial was conducted at multiple centers in the United States and involved 79 subjects. The study consisted of four arms: ACAM-FLU-A alone, ACAM-FLU-A plus aluminum hydroxide adjuvant, ACAM-FLU-A plus QS-21 adjuvant, and placebo. Subjects in the trial received two doses of the treatment to which they had been randomized. Overall, the trial results demonstrated that ACAM-FLU-A was well tolerated and capable of stimulating an immune response. Although immune responses were observed in all groups that received vaccine, the highest immune response was observed in the group vaccinated with ACAM-FLU-A plus QS-21 adjuvant. In this group, 90 percent of subjects generated virus-specific antibodies following immunization. "These findings continue to demonstrate the criticality of QS-21 as an adjuvant in a number of high-tech vaccine candidates," said Garo H. Armen, PhD, chairman and CEO of Antigenics. "QS-21 is a profitable product for Antigenics and our licensees' advancements continue to underscore the substantial contribution to Antigenics' future royalty income that could be generated from our adjuvant franchise." About QS-21 Stimulon Adjuvant Antigenics' QS-21 Stimulon adjuvant is one of the most widely tested vaccine adjuvants under development. QS-21 has not only become a critical component in the development of preventative vaccine formulations across a wide variety of infectious diseases, but may also be essential in enabling a new generation of therapeutic vaccines to treat cancer and degenerative disorders. QS-21 is currently being evaluated in more than 20 vaccine indications, several in late-stage clinical trials by Antigenics' licensees, including GlaxoSmithKline, Elan, Acambis and Progenics. About Antigenics Antigenics (NASDAQ: AGEN) is a biotechnology company working to develop treatments for cancers and infectious diseases. The company's investigational product portfolio includes Oncophage(R) (vitespen), a patient-specific therapeutic cancer vaccine being evaluated in several indications; Aroplatin(TM) (L-NDDP), a liposomal, third-generation platinum chemotherapeutic; AG-707, a therapeutic vaccine for the treatment of genital herpes; and QS-21, an adjuvant being evaluated by Antigenics' corporate partners in more than 20 indications, several in late-stage clinical trials. For more information, please visit antigenics.com. This press release contains forward-looking statements, including statements about potential future payments from Acambis to Antigenics, the potential for use of ACAM-FLU-A without annual reformulation or as a pandemic flu vaccine, and the commercial potential of QS-21. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, Antigenics' dependence on its collaborative partners such as ACM to successfully develop and commercialize products containing QS-21, which may not occur due to failure of future, larger clinical trials to replicate results from early-stage trials, negative decisions by regulatory authorities, or decisions by collaborative partners not to devote adequate resources to product candidates containing QS-21; the scientific risk associated with the development of vaccines; the competitive risk that other sources of competitive adjuvants could become available; difficulties or delays in manufacturing QS-21, future trials may not demonstrate that ACAM-FLU-A is safe and effective; and the risk factors described in the Management's Discussion and Analysis of Financial Condition and Results of Operations section of Antigenics' Form 10-Q as filed with the Securities and Exchange Commission on November 14, 2007. Antigenics cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this document, and Antigenics undertakes no obligation to update or revise the statements. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Antigenics' business is subject to substantial risks and uncertainties, including those identified above. When evaluating Antigenics' business and securities, investors should give careful consideration to these risks and uncertainties. CONTACT: Antigenics Inc. Media Relations: Sunny Uberoi, 212-994-8206 suberoi@antigenics.com or Investor Relations: Robert Anstey, 800-962-2436 ir@antigenics.com -----END PRIVACY-ENHANCED MESSAGE-----