Bloomberg reports the Pull of Vioxx Competitor's drug, Prexige

COMMENTARY:

Nov. 30 (Bloomberg)

Novartis AG, Switzerland's largest drugmaker, withdrew an application for European Union approval of its experimental Prexige, a painkiller similar to Merck & Co.'s Vioxx, as regulators review the safety of the drugs

"Prexige, already delayed by U.S. regulators, was considered one of the Basel, Switzerland-based company's most important new drugs to help boost earnings and was expected to be approved in most European markets next year. Lehman Brothers analysts earlier this year estimated Prexige may have peak annual sales of $2.4 billion, with $900 million coming outside the U.S."

This is a big blow to anyone, including Novartis, who hoped to see Cox-2 inhibitors staying on the market. Now, Novartis must seek its revenues elsewhere. Novartis follows Merck, who pulled its Cox-2 drug Vioxx after it was linked to a higher risk of heart attacks and strokes. Merck had recalled Vioxx on Sept. 30 as a result of finally conceeding that its own study showed a double the risk of heart attack and stroke compared to those on a placebo in the study.

This comes as no big surprise, since the FDA has now launched a panel to investigate COX-2 drugs like Vioxx. In an environment of increased scrutiny, it is unlikely that Prexige would win approval. According to Bloomberg, "The U.S. Food and Drug Administration is watching for signs of heart problems in research done on painkillers similar to the Vioxx. The agency plans to meet with outside medical advisers as early as January to weigh questions concerning the safety of Cox- 2 drugs and to seek advice on how best to monitor them and conduct further research. "

``Given the current review of the category we felt it was prudent to withdraw the filing for the time being,'' said Eric Altoff, Novartis spokesman.

Cox-2 inhibitors are popular, with sales of over $10 billion per year in the US alone. Vioxx has sales of $2.5 billion per year. Celebrex, $1.6 billion in six months.

The benefit of Prexige is that it caused fewer stomach ulcers than other painkillers. However, this may be the same mechanism that causes more heart attacks, some doctors suspect.

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