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news.Swiss drug company Novartis has abandoned clinical testing of its investigational cholesterol lowering drug NKS104 after studies showed it wasn't more effective than existing treatments. Additionally, an advisory panel has decided not to back the company's constipation treatment Zelnorm for marketing in Europe.
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As a result of NKS104’s disappointing performance, Novartis intends to book a $266 million charge in the fourth quarter of 2005 to fully write off the remaining value of the asset. Novartis already recorded an impairment of $66 million in the third quarter related to the acquired and capitalized marketing rights for NKS104. The company said it doesn’t anticipate the outcome will affect its ability to record group operating and net income for the overall year.
NKS104 (pitavastatin) is a type of statin, a popular class of drug used for lowering the risk of heart attack by reducing cholesterol levels. However, the statin market is already dominated by products like Merck & Co’s Zocor and Pfizer’s Lipitor.
Further bad news for Novartis came as the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) decided not to recommend the company’s product for irritable bowel syndrome (IBS). Novartis had been hoping to market its drug Zelnorm in Europe as a treatment for constipation related to IBS in female populations.
Following a review by the committee which began in October 2004, the European advisory panel decided not to endorse the product, a decision which is likely to be upheld by the European Commission. Novartis said it would appeal the unfavorable opinion.
The decision is somewhat of a surprise as the product is already approved in 56 countries so far and was approved in the US for use by women with constipation relating to IBS in 2002. However, labeling changes were made in 2004 to alert users to possible side effects of the treatment.
“Although we are disappointed with the CHMP opinion, we are confident in the clinical profile and benefits of Zelnorm. This product has been rigorously studied in more than seven placebo-controlled trials involving over 14,000 patients worldwide,” said James Shannon, head of global pharma development at Novartis.