Novartis has managed to consistently impress analysts with its savvy development strategy. The R&D division at the pharma giant follows a classic game plan: Take a promising drug, advance it down the pipeline for a small market and then branch out in pursuit of a gangbuster outcome in a big disease population.
For canakinumab, Novartis ($NVS) is putting that blockbuster strategy on steroids. Approved as Ilaris (and once best known as ACZ885) for Muckle-Wells syndrome, a very rare anti-inflammatory condition, Novartis has gone on to produce Phase III data for systemic juvenile idiopathic arthritis and promising mid-stage data for tumor necrosis factor (TNF) receptor-associated periodic syndrome--or TRAPS. Now, as The Wall Street Journal illustrates in an in-depth piece, the company's investigators are recruiting 17,000 patients on the gamble that the drug will guard at-risk cardiovascular patients suffering from a high level of chronic inflammation.
The C-reactive protein marker is known to flag patients with chronic inflammation, in which one of the body's natural protective measures turns into a threat, spiking the risk of heart attacks and strokes. Novartis as well as the NIH, which is funding a separate inflammation study on the generic standby methotrexate, are testing the hypothesis that reducing chronic inflammation will save many, many lives. And the theory will be put to the test in comparison to a study arm that is provided with the latest generation of statins, raising the bar on success considerably.
"The question is how difficult will it be to get above and beyond" the benefit of current treatments, Michael Miller, director of the center for preventive cardiology at University of Maryland Medical Center, tells the Journal. "The problem is the placebo group is going to be very well treated."
- here's the article from The Wall Street Journal
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