Novartis plans earlier cancer drug application

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Novartis plans earlier cancer drug application

Sun Jun 4, 2006 6:26pm ET12

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ATLANTA, June 4 (Reuters) - Novartis AG (NOVN.VX: Quote, Profile,

Research) (NVS.N: Quote, Profile, Research) said on Sunday it plans to

submit its application with U.S. regulators to market its new leukemia

drug earlier than expected.

The Swiss company said it plans to file its application for approval

of the drug, nilotinib, or AMN107, in late 2006 rather than in 2007 as

previously thought for patients with hard-to-treat leukemia.

The drug has received fast track designation in the United States,

which means it will be reviewed speedily by regulators, and it

received " orphan drug " status in the United States, which means if

approved it would receive seven years of marketing exclusivity. It

also has orphan designation in Europe.

Nilotinib is designed to fight treatment-resistant Philadelphia

chromosome-positive chronic myeloid leukemia.

Nilotinib is a successor to Novartis's revolutionary drug Gleevec,

which was the first cancer treatment to selectively target Bcr-Abl,

which causes Philadelphia chromosome-positive chronic myeloid leukemia.

© Reuters 2006. .