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Oncophage (HSPPC-96) Cancer Vaccine Receives European Orphan Drug Designation for Renal Cell Carcinoma
NEW YORK, NY -- June 7, 2005 -- Antigenics Inc. (Nasdaq: AGEN) today announced that Oncophage(R) (HSPPC-96), an investigational personalized cancer vaccine, has been granted orphan drug status for the treatment of renal cell carcinoma (RCC, the most common type of kidney cancer) by 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). The US Food and Drug Administration (FDA) previously granted orphan drug designation for Oncophage in RCC in May 2002.
"We are pleased with the EMEA's decision to grant Oncophage orphan drug status for RCC," stated Garo H. Armen, PhD, chairman and CEO of Antigenics. "In addition to the FDA's earlier orphan drug designation and recent agreement to our proposed registration plan for Oncophage in RCC, the European designation reinforces our belief that Oncophage has the potential to become a worldwide treatment alternative for patients with this devastating disease."
The EMEA regulation on orphan medicinal products is designed to encourage companies to develop and market treatments for rare, life threatening medical conditions that affect less than five people in every 10,000 in the EU. In addition to a 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.
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 to virtually eliminate the serious side effects associated with traditional cancer treatments. Oncophage is currently in Phase 3 trials for RCC and metastatic melanoma, and has been granted FDA fast track and orphan drug designations in both indications.
About Renal Cell Carcinoma
Renal cell carcinoma is the most common type of kidney cancer, accounting for about 85 percent of all kidney tumors. The American Cancer Society estimates that there will be more than 36,100 new cases of kidney cancer in the United States this year, and that almost 13,000 people will die from the disease.
SOURCE: Antigenics Inc.
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