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Biotech seeks OK for drug in Russia
Antigenics Inc., the developer of an immune-stimulating drug against kidney cancer, asked Russian regulators to approve its therapy, after a study failed to meet the statistical standard in the United States.
Clearance from the Russian Ministry of Public Health would allow marketing of the treatment, Oncophage, for patients with intermediate risk of relapse after kidney cancer surgery, the New York-based company said in a statement.
The treatment failed to reduce the risk of relapse in a trial of 604 patients, although it helped 60 percent of people with intermediate risk of recurrence, the company said. Such a "subset analysis" is usually rejected by US regulators, so Antigenics is applying first in Russia. Oncophage would be the company's sole marketed drug and could generate $100 million a year in sales, Antigenics said.
"Oncophage has a high chance of approval for sale," said Yuri Raifeld, chief executive of Raifarm, a drug consulting firm in Moscow, in an e-mail. "I would estimate it at 80 percent in Russia."
Raifeld, who is consulting for Antigenics, said Russian regulators probably will give Oncophage a chance because it demonstrated effectiveness for a large number of patients.
Antigenics shares rose 3 cents, or 1 percent, to $2.94 in Nasdaq Stock Market composite trading.
Oncophage's fate will depend on how regulators interpret results from 362 patients with intermediate risk of relapse, out of 604 total patients in a clinical trial.
In the group at intermediate risk, Oncophage stopped kidney cancer from coming back for 4.2 years, compared with 2.5 years for patients who didn't get the medicine, according to data presented at the American Urological Association meeting in Anaheim, Calif., in May. Patients on Oncophage had a 45 percent lower risk of relapse.
Oncophage didn't help patients with a high risk of relapse, according to a scoring system from the Eastern Cooperative Oncology Group, an association of cancer physicians.