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Lumiracoxib Issued Non-Approvable Letter

Basel, September 27, 2007 - Novartis has received a "not approvable" letter from the US Food and Drug Administration (FDA) for its COX-2 inhibitor lumiracoxib (Prexige) as a once-daily treatment for patients suffering from osteoarthritic pain.

The FDA's response came despite a clinical trial database for Prexige that comprises approximately 40,000 patients and is one of the largest bodies of evidence for any drug in this class.

In particular, results of the TARGET study involving more than 18,000 patients showed Prexige reduced the incidence of serious upper gastrointestinal complications by 79% compared to two widely-used non-steroidal anti-inflammatory drugs (NSAIDs) in patients not taking aspirin.

TARGET also showed Prexige was associated with significantly smaller increases in blood pressure than the NSAIDs naproxen and ibuprofen, with no significant difference in cardiovascular events such as heart attack or stroke.

"Many patients cannot tolerate the gastrointestinal side effects associated with NSAID pain treatments, such as those suffering from ulcers or who are being treated with anti-coagulants like warfarin," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "We believe Prexige remains an important therapy for appropriate patients with osteoarthritic pain, and we will continue discussions with the FDA."

At the FDA's request, Novartis submitted clinical data on the liver profile of the proposed 100 mg once-daily dose studied over 12 months of therapy. The results showed 0.85% of patients had elevations of the liver enzymes aspartate aminotransferase (AST) and alanine aminotransferase (ALT) of greater than "three times the upper limit of normal," which is similar to levels observed with currently available NSAIDs. There were also no cases of jaundice or hepatic failure on Prexige 100 mg once-daily dosing in the clinical development program. Despite this data, the FDA deemed Prexige not approvable.

The FDA noted in its response that it remained open to exploring the use of this medicine in patients where Prexige would provide an acceptable benefit-to-risk balance. This group could include patients with a higher incidence of gastrointestinal complications, including those suffering from ulcers or being treated with anticoagulants.

Source: Novartis

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