Shares of Antigenics Inc, the tiny New York-based  biotechnology company which has been developing the vaccine for  11 years, rose as much as 58 percent on the news. It is the first time the Russian government has approved a  drug that was not first cleared in its country of origin,  according to Antigenics, and clears the way for the company to  start generating revenue from Oncophage later this year. The company plans to file for approval of the vaccine in  Europe by the end of the year, based on a relatively new set of  guidelines in that jurisdiction. Regulators in Russia approved Oncophage based on a subset  of data from a late-stage clinical trial that in 2006 failed to  show the vaccine delayed the recurrence of kidney cancer. In the subset of patients — those whose cancer was least  likely to recur following surgery — Oncophage lengthened the  period before which the disease recurred by 45 percent, or an  average of 1.8 years, versus those in the control group. The U.S. Food and Drug Administration does not consider  subset analysis a valid measure of success or failure since all  manner of sub-populations can be carved out retrospectively. Therefore the vaccine stands little chance of approval in the  United States. “What this company needs to do now is a trial based on  their findings with the good prognosis patients,” said Dr. Otis  Brawley, Chief Medical Officer at the American Cancer Society. “If they have a positive finding at that point then I’m going  to be excited, and then I believe it would go before the FDA  very quickly.”    Conducting such trials, however, could take up to 10 years  and vast sums of money, and would take the product’s  development cycle to 20 years. “No one in their right mind would authorize that,” said  Garo Armen, the company’s chief executive, in an interview. “Even if we had the money it wouldn’t be practical.”     Unlike their U.S. counterparts, Russian regulators have  accepted the validity of the subset — in part because roughly  a third of the 604 patients enrolled in the late-stage trial  were tested in Russia, and about 70 percent of those fell into  the subset of patients whose prognosis following surgery was  better than that of the total population. Antigenics thinks it will be able to win approval elsewhere  in the world too. European regulators can now approve drugs on a conditional  basis, meaning companies can market their products while  simultaneously conducting additional follow-up of patients or  further clinical studies. If at the end of the trial period the regulatory agency  were not satisfied, it could pull the drug from the market. “Filing in Europe won’t be a slam dunk, and will probably  be more difficult than in Russia,” said Armen, who added that  the European review process would likely take 12 to 18 months. The Russian approval caps years of dogged determination to  bring the vaccine to the market despite multiple setbacks and  investor skepticism of cancer vaccines in general. Oncophage is designed to reprogram a patient’s immune  system to target cancer cells from a specific tumor. The company takes tissue from a tumor following surgery,  extracts proteins it says activate the immune system and then  injects the enriched proteins back into the body through the  skin. Unlike a vaccine such as Merck & Co’s Gardasil, which is  designed to ward off a virus that is believed to cause some 70  percent of cervical cancer cases, Oncophage is designed to  target the cancer directly and delay or prevent it from  spreading once it has developed. There are about 16,000 new cases of kidney cancer a year in  Russia, according to Armen, of which about a quarter fit the  profile of patients most likely to benefit from Oncophage — a  market theoretically worth about $200 million to Antigenics. The Russian pharmaceuticals market is one of the fastest  growing in the world. It will grow by nearly 60 percent to  $19.4 billion in 2009 from about $12.3 billion in 2006, the  research group DSM estimates. Armen said he expects the initial sales growth for  Oncophage to be “modest.”    “We would have to price this probably at the low- to  mid-range of other new-generation cancer drugs,” Armen said. Such drugs can cost as much as $60,000 per patient per  year, he said. “How much of that market we achieve depends on how well we  iron out reimbursement issues and how effectively we can reach  every single patient,” Armen said. Shares of Antigenics were up 62 cents or 25 percent to  $3.09 in late afternoon trading on Nasdaq after touching $3.90  earlier in the day, an increase of about 58 percent.
Antigenics wins Russian approval of cancer vaccine.