Novartis says Glivec misses main goal in study

By Sam Cage

ZURICH (Reuters) - Novartis AG's cancer drug Glivec failed to meet its main target in a late-stage study of patients with chronic myeloid leukaemia (CML), the Swiss drugmaker said on Friday.

Glivec, a once-a-day pill sold as Gleevec in the United States, is Novartis's second-biggest seller, raking in $3.1 billion in 2007.

Data from a Phase III study showed patients with newly diagnosed CML receiving a higher initial dose of Glivec showed better early responses than those taking smaller quantities.

However, the difference between the two arms of the study -- those taking 800 milligrams a day and others taking 400 mg -- "was not statistically significant," Novartis said.

"For now, we leave our Glivec forecasts unchanged, increasing from $3 billion in 2007 to $4.8 billion by 2011," said Landsbanki Kepler analyst Denise Anderson.

"However, the negative result may have a slight negative impact on Glivec sales as some patients were already using higher doses (mainly 600 mg) and may now be switched to another therapy," Anderson said.

Novartis shares were down 1.5 percent at 51.95 Swiss francs by 0810 GMT, compared with a 1.3 percent drop in the European pharmaceuticals sector.

Kepler's Anderson had not expected significant additional sales even if the trial had been positive, as the cost of treatment would have been high and other options are available, including Novartis's own Tasigna and Sprycel from Bristol-Myers Squibb Co.