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Why have the COX-2 inhibitors been so successful?


When asked this question by IMS Health, Monsanto Vice Chairman Richard De Schutter, naturally referring to Celebrex, said:

"Celebrex has been phenomenally successful because the market was desperately in need of such a product.

Up until the launch of Celebrex, many patients were not able to tolerate a therapeutic dose of the treatments available, because they ran into side effects (notably GI discomfort, bleeding and perforation).

The market subsequently exploded when Celebrex was launched. Searle moreover, made sure it had an adequate field force to market the product.

In the USA alone, based on epidemiological data showing that traditional NSAIDs are responsible for over 16,000 deaths annually, we are convinced that Celebrex has saved many lives as a major public health advance."

Furthermore, Searle has recruited more than 8,000 patients for the Celecoxib Long-term Arthritis Safety Study (CLASS), looking at the GI side effects of Celebrex versus traditional NSAIDs, and the results of this study are currently being analysed.

"If these studies prove positive, Searle will be in a position to petition the FDA to drop the insert label warning patients that the use of [newer] NSAIDs could cause GI bleeding, perforation and even death," stated Mr De Schutter.

Searle has other COX-2 inhibitors in phase III trials in its pipeline. Valdecoxib is an oral drug for the management of moderate to acute pain - according to Searle, it is very potent and could be a major non-narcotic analgesic with potential morphine-sparing advantages.

"Valdecoxib could have the same impact on the 'pain market' as Celebrex has had on the arthritis market," Mr De Schutter told IMS Health.

Parecoxib is indicated in the hospital setting for the intravenous management of acute pain. Parecoxib should be launched in early 2001, according to the company. "I believe that the pain/arthritis field is so enormous that it could accommodate these two new products as blockbusters in their own right," concluded Mr De Schutter.

For more of this interview, see the new IMS HEALTH Pharmaceutical Company Profile on Monsanto, available in April 2000.

Available to buy and download online now from IMS HEALTH:

Searle company profile

30 Mar 2000, Copyright IMS HEALTH

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