Antigenics to withdraw its MAA for Oncophage following CHMP’s negative opinion

Nov 20 2009

Antigenics Inc. (NASDAQ: AGEN) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has formally adopted a negative opinion on the marketing authorization application (MAA) for Oncophage (vitespen) as a treatment in earlier-stage, localized renal cell carcinoma (kidney cancer). A negative vote of the CHMP indicating this opinion was verbally conveyed to Antigenics and announced in a press release issued on October 21, 2009.

Based on this opinion, Antigenics has decided to withdraw its Marketing Authorization Application and to evaluate its options going forward, including a potential re-filing at a later date. A decision to re-file would be dependent on outcomes following meetings with health authorities in individual European countries and with the EMEA, as well as based on further accumulation and review of clinical data. In the meantime, Antigenics is hopeful that it will be in a position to supply Oncophage, as requested, under a named patient program in Europe, in addition to its ongoing commercial efforts in Russia and named patient programs elsewhere globally.

“Despite the CHMP’s negative decision, we continue to believe that the evidence supports Oncophage as a treatment option for a well defined patient group with localized renal cell carcinoma. It is for this reason that we continue our commitment to bring Oncophage to patients who can potentially benefit; these include patients with earlier stage kidney cancer where there are no available treatments,” commented Garo Armen, Chief Executive of Antigenics. “In addition to our ongoing clinical programs in glioma, we will investigate the use of Oncophage in combination with other cancer treatments with a strict focus on working efficiently and preserving our capital.”

No medication has been approved in Europe or the United States for the treatment of adjuvant kidney cancer, a disease characterized by a high risk of recurrence.