FDAnews Drug Daily Bulletin

NOVARTIS HALTS DEVELOPMENT OF CHOLESTEROL-LOWERING DRUG

Dec. 20, 2005
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Novartis has terminated development of an experimental cholesterol-lowering drug after clinical studies showed the treatment was not more effective than existing medications.

Pulling the plug on NKS104 (pitavastatin), a lipid-lowering agent in Phase II testing, will cost Novartis approximately $266 million, which will be booked in the fourth quarter, the Swiss firm said recently. Novartis previously announced in October it was "assessing" further development of pitavastatin based on mixed trial results.

The decision to stop development of the drug did not come as a surprise to financial analysts, who noted that clinical studies showed the drug might cause liver abnormalities. "The risks had been reasonably flagged by management over the last few months and this announcement shouldn't come as a complete surprise," analysts James Millett and Martin Brunninger of UK-based investment bank Cazenove wrote in a recent research note.

Bob Pooler, an analyst with Zurich-based investment bank Lombard Odier Darier Hentsch, offered similar comments, saying, "The discontinuation of NKS104 was widely anticipated due to the emergence of liver enzyme elevations and the lack of a major clinical differentiation over AstraZeneca's superstatin Crestor."

The NKS104 news was one of two development setbacks for Novartis last week. A European Medicines Agency (EMEA) advisory committee recently recommended against approval of Zelnorm (tegaserod), a drug intended to treat irritable bowel syndrome in women.

Although Zelnorm is already approved in the U.S., the EMEA's Committee for Medicinal Products for Human Use concluded that the drug's benefits do not outweigh its risks. Specifically, the EMEA advisers expressed concerns about the results of Novartis' supporting clinical data, which they said would not translate into real benefit for patients treated in a standard healthcare setting.