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Antigenics' Oncophage -HSPPC-96- Receives Orphan Drug Status in Melanoma; Second Orphan Drug Designation for Oncophage.


Business Editors & Health/Medical Writers

BIOWIRE2K

NOTE TO MEDIA: Multimedia assets available

NEW YORK--(BW HealthWire)--July 23, 2002

Antigenics Inc. (Nasdaq: AGEN) today announced that the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) has granted the company's personalized cancer vaccine Oncophage(R) (HSPPC-96) orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the  status for the treatment of metastatic Metastatic
The term used to describe a secondary cancer, or one that has spread from one area of the body to another.

Mentioned in: Coagulation Disorders


metastatic

pertaining to or of the nature of a metastasis.
 melanoma, providing the company with potential market exclusivity for seven years from FDA marketing approval.

The orphan drug program is intended to encourage research, development and approval of products for diseases that affect fewer than 200,000 patients in the United States. In addition to potential market exclusivity, orphan drug status provides tax incentives for up to 50 percent of a company's investment in U.S. clinical research, available funding to support clinical trials, and study design assistance. In May, Antigenics received its first orphan drug status for Oncophage in the treatment of renal cell carcinoma renal cell carcinoma
 or hypernephroma

Malignant tumour of the cells that cover and line the kidney. It usually affects persons over age 50 who have vascular disorders of the kidneys. It seldom causes pain, unless it is advanced.
.

"Beyond the fundamental advantages, what encourages us most about our latest orphan drug designation is the continued recognition that our flagship cancer product has the potential to change the lives of patients facing such a devastating dev·as·tate  
tr.v. dev·as·tat·ed, dev·as·tat·ing, dev·as·tates
1. To lay waste; destroy.

2. To overwhelm; confound; stun: was devastated by the rude remark.
 disease," said Garo H. Armen Garo H. Armen is chairman and chief executive officer of Antigenics Inc., the biotechnology company he cofounded with Pramod Srivastava in 1994. From mid-2002 through 2004, he was chairman of the board of directors for the biopharmaceutical company Elan Corporation plc. Dr. , Ph.D., Chairman and Chief Executive Officer of Antigenics. "Metastatic melanoma patients suffer an exceedingly compromised quality of life and have very limited options. As we continue moving Oncophage closer towards commercialization, we look forward to providing a superior treatment alternative for both patients and physicians."

Patients who receive treatment with Oncophage undergo surgery to remove all or part of the melanoma (which is used to make the personalized vaccine), followed by weekly injections of Oncophage. Derived from each individual's tumor, Oncophage contains the "antigenic fingerprint" of the patient's particular cancer, and is designed to reprogram re·pro·gram  
tr.v. re·pro·grammed or re·pro·gramed, re·pro·gram·ming or re·pro·gram·ing, re·pro·grams
To program again.



re
 the body's immune system immune system

Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders.
 to target and destroy only cancer cells bearing this fingerprint. Oncophage is intended to leave healthy tissue unaffected and prevent the debilitating de·bil·i·tat·ing
adj.
Causing a loss of strength or energy.


Debilitating
Weakening, or reducing the strength of.

Mentioned in: Stress Reduction
 side effects Side effects

Effects of a proposed project on other parts of the firm.
 associated with traditional cancer treatments such as chemotherapy and radiation therapy. It is currently being evaluated in pivotal Phase III studies for the treatment of renal cell carcinoma and malignant melanoma, and has been granted Fast Track designation from the FDA in both of these indications. Other clinical research evaluating Oncophage includes studies in several cancers such as lymphoma, colorectal, pancreatic and stomach cancers.

About Melanoma

According to the American Cancer Society American Cancer Society,
n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research,
, melanoma only accounts for about 4 percent of skin cancer cases, yet it causes about 79 percent of skin cancer deaths. It is estimated that in 2002, there will be almost 54,000 new cases of melanoma in the United States, and about 7,400 people will die of the disease. Current treatment options are limited to surgical removal, radiation therapy, chemotherapy, immune therapy or a combination of these treatments - all of which are associated with significant adverse effects.

About Antigenics

Antigenics' mission is to enhance and extend human lives through the development of superior health care products for a wide range of cancers, infectious diseases, and autoimmune and degenerative disorders. The company's cancer portfolio includes Oncophage, a personalized cancer vaccine in Phase III trials and on the FDA's Fast Track development program for kidney cancer and melanoma; and two liposomal products in Phase II development: Aroplatin(TM), a third-generation platinum chemotherapeutic, and ATRA-IV, a form of vitamin A. Other products in development include QS-21, an immune adjuvant adjuvant /ad·ju·vant/ (aj?dbobr-vant) (a-joo´vant)
1. assisting or aiding.

2. a substance that aids another, such as an auxiliary remedy.

3.
 being tested in several advanced clinical vaccine programs in partnership with leading pharmaceutical companies, and AG-702, a genital herpes immunotherapeutic agent in Phase I testing. For more information about Antigenics, please visit www.antigenics.com.

This press release contains forward-looking statements, including the statements regarding the impact of orphan drug designation and the development and commercialization 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 orphan drug status may not be maintained in the event of legislative changes or introduction of a more efficacious product in this disease category; that we may not be able to enroll sufficient numbers of patients in our clinical trials; that our clinical trials may not demonstrate that our products are both safe and more effective than current standards of care Standards of care are medical or psychological treatment guidelines, and can be general or specific. They specify appropriate treatment protocols based on scientific evidence, and collaboration between medical and/or psychological professionals involved in the treatment of a given ; that we may be unable to obtain the regulatory approvals necessary to conduct additional clinical trials or to market products; that we may fail to adequately protect our intellectual property or are determined to infringe on the intellectual property of others; and the factors described in the company's periodic filings with the Securities and Exchange Commission. Please see Exhibit 99.1 of the Annual Report on Form 10-K for a full discussion of these risk factors. We caution investors not to place undue reliance on the forward-looking statements contained in this document. These statements speak only as of the date of this document, and we undertake no obligation to update or revise the statements. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

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Publication:Business Wire
Geographic Code:1USA
Date:Jul 23, 2002
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