NOVARTIS PRESENTS DATA ON DRUG FOR GLIVEC-RESISTANT PATIENTS

New clinical data presented by Novartis demonstrate that Tasigna (nilotinib) eliminated or significantly reduced the presence of blood cells containing a defective chromosome in approximately half of adult patients with a form of life-threatening leukemia who developed resistance or intolerance to treatment with Glivec (imatinib).

The reductions achieved in these patients resistant to Glivec may be the highest ever reported with a targeted therapy at six months of follow-up, according to Novartis.

The open-label, Phase II data, which forms the basis for U.S. and EU regulatory submissions completed earlier in 2006, showed that the use of Tasigna in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) reduced or eliminated the presence of this defective chromosome in 51 percent of Glivec-resistant patients in chronic phase of this disease and led to normalized white blood cell counts in 74 percent of these patients. The study was conducted in 279 patients.

The study also showed a similar magnitude of elimination or reduction of these defective cells in 55 percent of intolerant patients. The data were presented at the American Society of Hematology annual meeting.

Novartis has filed applications with both the FDA and European Medicines Agency for Tasigna as a therapy for adult patients with chronic or accelerated phase Ph+ CML with intolerance and/or resistance to Glivec. Tasigna was developed by Novartis as a next-generation targeted therapy based on the success of Glivec.