The name "European League Against Rheumatism" sounds like a bunch of doctors running around like crazed soccer hooligans. But there was nothing scary about the data that Schering-Plough
The pair presented results from three phase 3 clinical trials testing golimumab, an anti-TNF drug, in patients with rheumatoid arthritis. The trials covered the gamut of patient classes: those that had never received treatment; those that had failed the standard treatment, methotrexate; and those that had failed treatment with other anti-TNF drugs, such as Abbott Labs'
According to the press releases, golimumab reduced the previously untreated subjects' symptoms more than placebo, but that may not be enough to get the drug a first-line indication. In the second group, those for whom methotrexate didn't work, golimumab reduced symptoms by a statistically significant margin. The drug also worked on the third group, those who had previously failed other anti-TNF drugs. That's perhaps the most important result, since it's estimated that 20% of patients fail with other anti-TNF drugs, so there's a considerable market up for grabs.
The application to market the drug in the U.S. should be filed by the end of the month, and the European application was filed in March. If it's approved, the drug will be marketed by Schering in Europe.
The question, then, is why does Johnson & Johnson need the smaller Schering to market the drug overseas? Actually, it doesn't, but it has to. Schering made a deal to market Centocor's Remicade with an option for future anti-TNF compounds in 1998, the year before J&J bought that company. Johnson & Johnson had been trying to get out of the deal, but has since agreed to let Schering market Remicade and golimumab for 15 years after golimumab hits the market.
It will be a while before we know how much of the anti-inflammatory market golimumab can snatch up, but the results presented this week suggest that it shouldn't have too much trouble getting past the regulatory authorities -- or even a band of ravenous doctors.