Panel view on Merck pain drug key for Novartis too
LONDON, April 11 (Reuters) - A keenly awaited U.S. panel hearing on Merck & Co. Inc.'s (MRK.N) pain reliever Arcoxia will be important also for Swiss rival Novartis AG (NOVN.VX), according to industry analysts.
More than two years after Merck was forced to pull Vioxx from the market because of cardiovascular side effects, both firms are trying to get newer drugs in the same Cox-2 inhibitor class approved in the United States.
Arcoxia is to be assessed by a Food and Drug Administration
(FDA) expert panel on Thursday in a move that is likely to have ramifications for Novartis's chances of winning a U.S. green light for Prexige.
"There should be a clear read-across as to what might be in store for Prexige. If Arcoxia doesn't make it, it will be much more difficult for Prexige," Sanford Bernstein analyst Gbola Amusa said.
Novartis resubmitted its drug to U.S. regulators in the first quarter of 2007 and the company said in January it still believed Prexige could be a blockbuster -- defined as selling $1 billion a year.
Analysts, however, say this will hinge on the drug winning acceptance in the United States, the world's biggest market.
PREXIGE IN EUROPE
Prexige is already approved in 40 countries worldwide but it has yet to be launched in Europe, despite having regulatory clearance in Britain and Germany. Company spokesman John Gilardi said launches in European markets were currently being planned.
Arcoxia, meanwhile, is already sold in Europe and other countries outside the United States.
Denise Anderson of Kepler Equities, who currently forecasts modest Prexige sales of $200 million in 2010, agrees negative news on Arcoxia this week would lower the chances of Prexige securing a U.S. foothold, although the issues surrounding the two drugs are not identical.
Prexige has become more important as a driver for Novartis's pharmaceuticals business following the withdrawal of bowel drug Zelnorm on March 30 and delays to diabetes drug Galvus, she added.
Cox-2 inhibitors remain highly sensitive for the FDA, which was heavily criticised in the wake of Vioxx debacle.
Merck pulled Vioxx in 2004 when research showed the drug doubled heart attack and stroke risk in people who took it for at least 18 months and pain relievers have received intense scrutiny since.
Both Arcoxia and Prexige work through the same mechanism as Vioxx, by targeting the Cox-2 enzyme involved in inflammation, as does Pfizer Inc.'s (PFE.N) approved drug Celebrex.
They are part of a larger class of drugs known as non-steroidal anti-inflammatory drugs.
Some heart experts have voiced concern that Arcoxia patients appear to show higher rates of elevated blood pressure, tissue swelling and congestive heart failure.
At issue is whether new Cox-2 drugs are needed or are worth the risk. Drug manufacturers argue they have a role because not all patients are adequately treated with existing medicines.
((Reporting by Ben Hirschler; Editing by David Cowell; email: ben.hirschler@reuters.com; Reuters Messaging: ben.hirschler.reuters.com@reuters.net; +44 20 7542 5082)) Keywords: MERCK ARCOXIA/NOVARTIS
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