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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT FILED PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
DATE OF REPORT
(DATE OF EARLIEST EVENT REPORTED):
SEPTEMBER 21, 2001
ANTIGENICS INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
DELAWARE 000-29089 06-1562417
(STATE OR OTHER JURISDICTION OF (COMMISSION FILE NUMBER) (I.R.S. EMPLOYER IDENTIFICATION NO.)
INCORPORATION OR ORGANIZATION)
630 FIFTH STREET, SUITE 2100
NEW YORK, NEW YORK 10111
(ADDRESS OF PRINCIPAL
EXECUTIVE OFFICES
AND ZIP CODE)
(212) 332-4774
(REGISTRANT'S TELEPHONE NUMBER,
INCLUDING AREA CODE)
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ITEM 5. OTHER EVENTS AND REGULATION FD DISCLOSURE.
In August, we had a series of meetings with the U.S. Food and Drug
Administration ("FDA") to discuss, among other things, the clinical development
strategies for some of our products. The following are important outcomes from
those meetings:
- The FDA informed us that Oncophage(R), our lead cancer vaccine, may
meet the requirements needed for designation as a "Fast Track"
product. This designation could potentially shorten our approval
timeline once we have sufficient data from our Phase III clinical
trial in renal cell carcinoma and our planned pivotal trials for
metastatic melanoma. Because of this, we have submitted an application
for "Fast Track" designation with the FDA and we anticipate a response
from the FDA early in the fourth quarter.
- Based on our follow-up meeting with the FDA regarding ATRAGEN(R), our
intravenous formulation of all-trans-retinoic acid, we think that an
accelerated approval of ATRAGEN in acute promyelocytic leukemia is
unlikely. Therefore, we are focusing our development strategy for
ATRAGEN on other cancer indications that represent larger market
opportunities.
This Current Report on Form 8-K contains forward-looking statements. These
include statements about the period during which we expect to receive a response
to our application for "Fast Track" designation for Oncophage and the length of
the approval timeline for Oncophage. Several risks and uncertainties could cause
actual results to differ materially from those projected in the forward-looking
statements. These factors include our ability to satisfy regulatory
requirements, the progress and ultimate outcome of our clinical trials,
competition from pharmaceutical and biotechnology companies and other risks
identified in our SEC filings.
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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: September 21, 2001
By: /s/ Garo H. Armen
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Garo H. Armen, Ph.D.
Chairman and Chief Executive Officer