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More COX-2 warnings fuel fears

A further two, as yet unapproved, COX-2 inhibitors have been added to the growing list of drugs in the class that poses cardiovascular risks.

A further two, as yet unapproved, COX-2 inhibitors have been added to the growing list of drugs in the class that pose cardiovascular risks, according to the findings of a study into Merck's Arcoxia and Novartis' Prexige released by the Food and Drug Administration (FDA).

An FDA analyst said Merck's Arcoxia, the successor to Vioxx, ìis worse compared with other drugsî in the class. Merck retorted, however, that: ìArcoxia has the potential to become a valuable therapeutic alternative.î

Wood Mackenzie analysts, Stuart Bowman and Eugene Benson, noted that as investigations into the whole COX-2 inhibitor class start to yield results, it looks likely that Merck will not find solace in Arcoxia, that it had hoped: ìThe withdrawal of Vioxx leaves an important revenue/growth gap at Merck [and the] future of the company's follow-up COX-2 inhibitor is at risk.î

They added, separately, that ìshould Prexige fail to reach the market this would be a significant blow to Novartis given its R&D investment to dateî.

The US regulator has asked a panel of experts to consider whether the risks of all drugs in the entire class outweigh the benefits and whether all COX-2 inhibitors should be withdrawn from the market.

Two rival medicines from Pfizer, Celebrex and Bextra, have also been in the firing line regarding safety concerns. ìThe bigger issue [for Pfizer] could be any resultant litigation,î noted Wood Mackenzie, which plans to undertake a deeper analysis of the issues surrounding the COX-2 class, including the ability of regulators, the need for regulatory reform and the potential impact of such reform on R&D.

The world's focus on the potential risks of the once breakthrough COX-2 inhibitor class is driving regulators to put each such drug under intense scrutiny.

ìIt is clear that the challenges facing the pharmaceutical industry are becoming ever more intense,î added Bowman and Benson.

30th September 2008

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