-----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, DSXoVfrfpXd+rir+s85OwCvvo7uVk4qY2p7Qx82P3GbnBcHiho1ilWp+Wc75m1x3 v0s2F7MvDZ8dyD+fQmTinQ== 0001157523-09-002035.txt : 20090312 0001157523-09-002035.hdr.sgml : 20090312 20090312072723 ACCESSION NUMBER: 0001157523-09-002035 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20090312 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090312 DATE AS OF CHANGE: 20090312 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: 09674094 BUSINESS ADDRESS: STREET 1: 162 FIFTH AVENUE SUITE 900 CITY: NEW YORK STATE: NY ZIP: 10010 BUSINESS PHONE: 212-994-8200 MAIL ADDRESS: STREET 1: 162 FIFTH AVENUE SUITE 900 CITY: NEW YORK STATE: NY ZIP: 10010 8-K 1 a5915565.htm 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

March 12, 2009
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

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

3 Forbes Road

Lexington, MA

02421

(Address of principal executive offices)

(Zip Code)


781-674-4400
(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 March 12, 2009, Antigenics Inc. announced that Oncophage® (vitespen) has been granted a positive recommendation for orphan drug designation for the treatment of glioma by the Committee for Orphan Medical Products of the European Medicines Agency. This designation provides Antigenics with, among other benefits, 10 years of potential market exclusivity if the product is approved for marketing in the European Union.

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 March 12, 2009


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: March 12, 2009 By:

/s/ Garo H. Armen

 

Garo H. Armen

Chairman and CEO


EXHIBIT INDEX

Exhibit No.

Description of Exhibit

 
99.1

Press Release dated March 12, 2009

EX-99.1 2 a59125565ex99_1.htm EXHIBIT 99.1

Exhibit 99.1

Antigenics’ Oncophage Cancer Vaccine Receives European Orphan Drug Designation for Brain Cancer

NEW YORK--(BUSINESS WIRE)--March 12, 2009--Antigenics Inc. (NASDAQ: AGEN) today announced that Oncophage® (vitespen) has been granted a positive recommendation for orphan drug designation for the treatment of glioma by the Committee for Orphan Medical Products (COMP) of the European Medicines Agency (EMEA). This designation provides Antigenics with, among other benefits, 10 years of potential market exclusivity if the product is approved for marketing in the European Union (EU).

This is the second indication for which the EMEA has granted orphan drug status to Oncophage. In April 2005, Oncophage received orphan drug designation in the European Union for the treatment of renal cell carcinoma (kidney cancer). Subsequently, Antigenics submitted a Marketing Authorization Application (MAA) to the EMEA in October 2008 requesting approval for Oncophage in earlier-stage, localized renal cell carcinoma.

“We are committed to supporting the evaluation of Oncophage in patients diagnosed with glioma, as this remains a life-threatening disease with limited treatment options,” stated Garo Armen, PhD, chairman and CEO of Antigenics. “Furthermore, orphan drug status has the potential to accelerate the development of Oncophage in this patient population, which is critical given the poor survival rates.”

The EMEA regulation on orphan medicinal products is designed to promote the development of drugs, which may provide significant benefit to patients suffering from rare diseases identified as “life-threatening or very serious.” In addition to potential 10-year EU market exclusivity following marketing approval, orphan drug status provides regulatory assistance, reduced regulatory fees associated with applying for marketing approval, and protocol assistance.

About Oncophage

In April 2008, Oncophage was approved in Russia for the adjuvant treatment of kidney cancer patients at intermediate-risk for disease recurrence. In October 2008, Antigenics submitted a MAA to the EMEA requesting approval for Oncophage in earlier-stage, localized renal cell carcinoma.

Derived from each individual’s tumor, Oncophage contains the ‘antigenic fingerprint’ of the patient’s particular cancer and is designed to reprogram the body’s immune system to target only cancer cells bearing this fingerprint. Oncophage is intended to leave healthy tissue unaffected and limit the debilitating side effects typically associated with traditional cancer treatments such as chemotherapy and radiation therapy. Oncophage has been studied in Phase 3 clinical trials for the treatment of kidney cancer and metastatic melanoma and is currently being investigated in a Phase 1/2 trial in recurrent glioma.

Oncophage has also received fast track and orphan drug designations from the U.S. Food and Drug Administration for both kidney cancer and metastatic melanoma.

About Brain Tumors

Glioma is the most common type of brain tumor and is currently a fatal disease impairing areas such as thinking, personality and movement. The National Cancer Institute estimates that about 19,000 cases are diagnosed every year in the U.S. and according to historical estimates, the median survival of patients with previously treated glioma is typically three to six months.


About Antigenics

Antigenics (NASDAQ: AGEN) is a biotechnology company working to develop treatments for cancers and infectious diseases. For more information, please visit antigenics.com.

This press release contains forward-looking statements, including statements regarding the potential impact of EMEA orphan drug designation, and the development, clinical, and commercial potential of Oncophage. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, that Oncophage may not be approved for sale outside of Russia and, regardless of approval, may not succeed commercially; that orphan drug status may not be maintained in the event of legislative changes or introduction of a more efficacious product in this disease category; and the factors described in the company’s periodic filings with the Securities and Exchange Commission. Please see the factors described under the Risk Factors section of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission for the period ended September 30, 2008 for a more complete discussion of these and other risk factors. The grant of orphan designation by the EMEA does not assure rapid regulatory decision-making or approval. 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
Media:
Sunny Uberoi, 212-994-8206 or 917-443-3325
or
Investors:
Robert Anstey, 800-962-2436

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