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To: Joe Krupa who wrote (8125)	11/28/2001 8:41:16 PM
From: Joe Krupa	Read Replies (1) of 14101

You've got to like this press release (thanks ticktalker on SH): ********************* news.ft.com Pharmacia bows out of warning label fight By Adrian Michaels in New York Published: November 28 2001 19:53 \| Last Updated: November 28 2001 23:13 Pharmacia on Wednesday signalled that it had given up its fight to boost sales of its flagship arthritis drug by having new warning labels approved by regulators. The US pharmaceuticals company admitted that its long and expensive campaign to sway the US Food and Drug Administration into toning down the warnings on Celebrex had probably failed. The effort involved large extra clinical trials and intensive lobbying of the regulator. However the FDA has for months not issued a ruling and Pharmacia said on Wednesday that the particular warning it wanted taken off the label would "not likely be removed". The move is a blow to the company, which receives over $3bn in sales of Celebrex but has seen the drug's meteoric sales growth slow faster than expected because of concerns over safety and heightened price sensitivity among US patients. It said on Wednesday at an analysts' meeting in New York that the overall market growth for drugs in the same class would be only single digits next year. The company will be boosting growth in part by jettisoning Monsanto, its slower-growing agricultural subsidiary. Pharmacia's frank assessment of the failure of its labelling efforts could also have an impact on Merck, whose drug Vioxx is locked in an intense struggle for market share with Celebrex. Merck has also conducted a large, expensive, trial and been lobbying for a softer warning label on Vioxx. It has also yet to hear from the FDA. Pharmacia said on Wednesday that it thought its rival's labelling efforts would fail. Merck cut its sales estimates for Vioxx in October. Pharmacia has gained a lead over Merck in the battle of the successors to their arthritis drugs. Last week the FDA gave Pharmacia approval to market Bextra, its Celebrex follow-up. The approval came a few months earlier than expected and well ahead of Merck's follow-up. However Pharmacia lost its battle to have Bextra approved as being more effective than Celebrex in tackling pain, a key indication that would have boosted sales. It will have to conduct further clinical studies if it wants to persuade the FDA on pain relief. The company said on Wednesday that after the Monsanto sale it would derive 85 per cent of its revenues from prescription drugs. **********************************

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