The UK, Germany and Austria on Monday suspended sales and marketing of Novartis’ COX-2 class painkiller Prexige due to fears the drug may cause liver damage in some patients.
Today’s Prexige suspension comes on the heels of the FDA’s September decision to issue a non-approvable letter for the drug as an arthritis treatment in the US.
Novartis said in a statement that it still believes that Prexige is a “valuable treatment option for patients” and plans to continue discussions with European regulators regarding the drug’s safety.
Prexige had sales of $8 million in Europe for the first nine months of 2007, according to company sales figures.
Novartis had once touted Prexige as a potential blockbuster, with hopes for sales of over $1 billion a year, but CEO Daniel Vasella said in September that the drug was a long shot to gain US approval after Australian regulators withdrew it from the market in early 2007 due to safety concerns.
The Prexige suspensions were “not unexpected, considering what happened in the US and Australia,” wrote Andreas Theisen, a pharmaceutical analyst with West LB in Germany. Theisen has a hold rating on the stock. “I think the market was anyway cautious with this product now and it shouldn’t therefore have a major impact on expectations.”
Prexige’s suspension in Europe is just the latest in a series of blows the company has encountered during 2007.
Last month, the company announced plans to eliminate 1,260 jobs from its US sales and marketing unit and replace its head of pharmaceuticals after announcing poor third-quarter earnings results.
Joe Jimenez, who joined Novartis in April from Blackstone as head of the consumer healthcare unit, stepped in to run the company’s pharmaceuticals unit. Jimenez traded places with Thomas Ebelin, who moved to Novartis’ smaller consumer unit.
Meanwhile, Zelnorm sales fell 80% after the company was forced to pull the irritable bowel treatment from the market in March due to safety concerns. Generic competition caught up to Lamisil, Lotrel and Famivir and type 2 diabetes drug Galvus, was delayed at the FDA.
