LEXINGTON, Mass. (
) --European regulators plan to reject the approval of
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kidney cancer vaccine Oncophage, the company announced Wednesday.
Antigenics shares were plunging 43% to $1.19 in pre-market trading.
Antigenics sought the blessing to sell Oncophage in Europe despite the fact that the cancer immunotherapy, or vaccine,
failed a pivotal phase III study
in kidney cancer. A pivotal study of Oncophage in skin cancer failed, too.
In fact, the only "positive" data on Oncophage comes from retrospective, data-mined analyses of the kidney cancer study. These dubious data may have hoodwinked some retail investors into believing in the benefit of Oncophage, but European regulators were
The negative opinion on the marketing of Oncophage in Europe will be made official when regulators convene their November meeting, Antigenics said. The company may appeal the ruling.
Antigenics has previously stated that it cannot seek Oncophage's approval in the U.S. because of the failure of the drug's phase III study.
That leaves Antigenics trying to sell Oncophage in Russia, where it was approved in April 2008, the company claims. When Antigenics will actually start selling the drug there is anyone's guess, since the company says it is still negotiating the drug's reimbursement with the Russian government.
At a recent investor meeting in September, Antigenics' CFO Shalini Sharp didn't sound all that confident about generating Russian Oncophage revenue any time soon.
"The timeline is uncertain at this point," said Sharp, when asked about reimbursement negotiations between Antigenics and the Russian government.
Outside of Oncophage, Antigenics owns a vaccine adjuvant booster, QS21, in various stages of testing through partners, including
. Yet, Antigenics will only earn a small royalty on sales of vaccines that include QS21 and this expected revenue
the company's current valuation.
-- Reported by Adam Feuerstein in Boston
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