Exhibit 99.1
Antigenics Provides Update on Filing for Approval of Oncophage(R) in Russia
for the Treatment of Intermediate-Risk Kidney Cancer
Application Based on Investigator-Reported Results of Phase 3
Study Showing That Oncophage Significantly Prolongs Recurrence-Free
Survival by 45 Percent in Patients With Intermediate-Risk Kidney
Cancer
NEW YORK--(BUSINESS WIRE)--Aug. 2, 2007--Antigenics Inc. (NASDAQ:
AGEN) today announced that it has completed the submission of an
application for marketing authorization with the Russian Ministry of
Public Health for the use of Oncophage(R) (vitespen) in the treatment
of kidney cancer patients at intermediate risk for disease recurrence.
"This submission represents a key milestone in the advancement of
our global registrational strategy for Oncophage," said Garo H. Armen,
PhD, chairman and CEO of Antigenics. "The final results that were
submitted to the Russian Ministry of Public Health and that will be
presented at a scientific conference later this year indicate
substantial benefit in this clinically relevant subset of kidney
cancer patients for whom no licensed treatment options exist globally.
"Based on the feedback we received from key experts and
investigators, we have a responsibility to bring Oncophage to patients
and we look forward to working closely with the Russian Ministry of
Public Health in what could be the first available therapeutic cancer
vaccine approved in the adjuvant setting anywhere in the world,"
continued Dr. Armen. "In addition, we will explore making Oncophage
available to patients in geographical territories such as Europe and
Canada, as well as remain committed to seeking guidance from the US
FDA."
According to RMBC, a Russian data provider, the Russian oncology
market in 2005 was valued at $387 million but is expanding at an
unprecedented rate: by 2008, the Russian oncology market is estimated
to be valued at approximately $940 million, an increase of 142
percent. One of the most important factors driving growth of the
Russian drug market has been the introduction of the Beneficiary Drug
Provision Program (DLO), a governmental reimbursement program
introduced in January 2005. Under the program, more than 14 million
Russians are provided with medicines subsidized by the federal budget.
According to Group DSM, a Russian data provider, the Russian
pharmaceutical market will grow to $15-17 billion by 2010, contingent
upon the continuation of the DLO program.
Antigenics' filing with the Russian Ministry of Public Health
contains final investigator-reported results from the largest,
randomized, Phase 3 kidney cancer trial ever completed in the adjuvant
treatment setting. In the study, 604 eligible patients who were
without renal cell carcinoma disease at baseline were randomized at
118 centers worldwide, including 172 patients (28 percent) at eight
sites in Russia. The primary efficacy data supporting this application
were recently presented at the June 2007 annual meeting of the
American Urological Association and are currently being prepared for
publication. Results from investigator-reported data showed that
patients receiving Oncophage in the intermediate-risk population
(stages I/II high-grade, III T1/2/3a low-grade) who were without
disease at baseline (n = 362) demonstrated a clinically significant
improvement in recurrence-free survival of approximately 45 percent (P
less than 0.01; hazard ratio = 0.55). Although the median has not yet
been reached, results from the 25th percentile indicate that
recurrence-free survival was extended by approximately 1.8 years. The
most common adverse events reported during the trial were generally
mild and expected. The more frequently reported adverse events were
mainly constitutional in nature or related to the actual injection.
Final investigator-reported data will be presented at European and
Russian scientific conferences.
About Oncophage
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 received fast track and orphan drug designations
from the US Food and Drug Administration for both kidney cancer and
metastatic melanoma. Oncophage has orphan drug status for kidney
cancer from the European Medicines Agency.
About Renal Cell Carcinoma
Renal cell carcinoma is the most common type of kidney cancer. The
most recent data published by the International Agency for Research on
Cancer estimated that there were approximately 16,329 new cases of
kidney cancer in Russia in 2004, and about 10,872 people died from the
disease. Renal cell carcinoma accounts for about 90 percent of all
kidney tumors. By the time renal cell carcinoma is diagnosed in these
patients, about one third of them will have developed metastatic
disease.
The current standard of care for patients with nonmetastatic renal
cell carcinoma consists of a nephrectomy (surgical removal of the
kidney) followed by observation. Globally, there is no treatment
approved for nonmetastatic renal cell carcinoma at the present time.
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 used in numerous
vaccines under development by Antigenics' collaborative partners. For
more information, please visit antigenics.com.
This press release contains forward-looking statements, including
statements regarding the potential approval of Oncophage in Russia and
the potential impact this may have on the advancement of our
registration efforts for Oncophage in other territories; the clinical
benefit of Oncophage in kidney cancer based on a subgroup analysis;
the potential growth and opportunities in the Russian oncology market
and the potential impact of the Russian government reimbursement
program; and the presentation of data on our Phase 3 kidney cancer
trial. 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, decisions by
regulatory agencies; the uncertainty of the continuation of the DLO
program or its application to Oncophage and the application of similar
reimbursement programs in other territories; that efforts in Russia
may not impact our efforts in other territories; the ability to raise
capital and finance future activities for the development and
registration of Oncophage; and the factors described under Factors
That May Impact Future Results 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 May 10, 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, 917-443-3325
suberoi@antigenics.com
or
Investor Relations
Robert Anstey, 800-962-2436
ir@antigenics.com