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Pharmion Surges on Study Data

Phase III trial for Vidaza show increased survival rates for patients with MDS.



soared more than 50% Thursday on data from a phase III trial for Vidaza, a treatment for patients with higher-risk myelodysplastic syndromes (MDS).

Vidaza increased median survival for patients with MDS -- a rare group of diseases in which bone marrow doesn't function normally, causing the body to produce malformed or immature blood cells -- by 9.4 months compared to those receiving conventional care regiments (CRR). The treatment extended overall survival by 74%, and two-year survival rates were 51% for patients taking Vidaza compared to 26% for CCR in the study.

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The company is going to file a marketing authorization application (MAA) in the European Union for Vidaza for the use indicated in the study before the end of this fiscal year and will then submit it internationally.

In the U.S., the drug is already approved to treat patients with all five subtypes of MDS. The company will file a supplemental new-drug application with the Food and Drug Administration with regard to the new data.

"We are extremely gratified with the results from the Vidaza survival study, which for the first time bring the hope of prolonged survival for patients with higher-risk MDS," said Pharmion CEO Patrick Mahaffy. "As the only therapy to have ever demonstrated a survival advantage in MDS, and especially to have demonstrated an improvement of this magnitude, Vidaza is unique in the treatment for this disease."

Pharmion said MDS affects about 40,000 to 50,000 people in the U.S. and 75,000 to 85,000 in Europe, and that most patients with higher-risk MDS eventually experience bone marrow failure. MDS patients have a median survival of four months to five years, and higher-risk patients have a median survival of five to 14 months.

Investors pushed the stock up $14.32, or 58%, to $38.96.