"The registration of Oncophage in Russia represents an important treatment advancement for patients with intermediate-risk kidney cancer," Antigenics Inc quoted its CEO Garo H. Armen, as saying on its website. "We are very pleased that Oncophage is the first personalized cancer vaccine that will be available in any major country.'
"This registration means patients in Russia with earlier-stage disease will now have Oncophage as a treatment option," the company quoted Vsevolod Matveyev of the Blokhin National Cancer Research Center in Moscow as saying.
Antigenics has failed to complete a series of trials in the United States and will not be able to market Oncophage there for a while. However, it expects to launch the therapeutic vaccine in Russia in the second half of 2008. It also plans to file for the conditional approval of Oncophage in Europe this year.
Armen assessed the Russian market at $200 million and prospects for Oncophage sales in the country as "moderate." The businessman described Russia as a key market that will enable Antigenics to seek recognition in Europe.
The U.S. company said it had submitted an export license application to the U.S. Food and Drug Administration (FDA), expecting the regulator to make a decision within 60 days of submission.
Antigenics said Oncophage was derived from "each individual's tumor" to prevent or delay the recurrence of kidney cancer, which means it can be used in addition to conventional treatments. Oncophage is also believed not to have the debilitating side effects typically associated with traditional cancer treatments.
