Prexige launch delayed
pharmafile | October 27, 2004 | News story | |Â Â Â
Novartis has delayed the launch of its potential blockbuster painkiller Prexige until 2007, in the wake of Vioxx's withdrawal.
The company had planned a worldwide launch in 2005 for its arthritis and pain treatment after positive trial data showed a superior side-effect profile to existing Cox-IIs, including Celebrex and Vioxx.
The TARGET study, published in The Lancet in August showed Prexige significantly reduced gastrointestinal ulcer complications without compromising cardiovascular health. But the subsequent withdrawal of Vioxx by Merck for safety reasons has forced the company to rethink its plans.
Merck pulled its $2.5 billion blockbuster from global markets after a large-scale trial showed long-term use of the drug doubled the risk of heart attacks and strokes.
Raymund Breu, Novartis' chief financial officer, described the delay as "prudent" following the withdrawal of Vioxx at the end of September, amid safety fears.
Despite gaining UK approval last year, Prexige was originally rejected by the FDA in 2003, a move which caused analysts Deutsche Bank to cut in half its forecast sales for the drug in 2007 from just over $1 billion to $500 million, representing around 5% of the Cox-II market.
The company planned to resubmit the TARGET study results to the FDA, anticipating a 2005 launch, but the Vioxx withdrawal means the resubmission will now be pushed back to 2007.
Despite the setback Novartis has been buoyed by a strong third quarter performance, with net income rising 21% to $1.5 billion and turnover increasing 14% to $7.1 billion. Strong growth in prescription pharma sales, including blood pressure drug Diovan and cancer treatment Glivec, were behind the unexpected figures.
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