Forbes StaffThis morning, Novartis, the Swiss drug giant, announced that a drug that targets inflammation prevented heart attacks and strokes in a 10,000 patient trial of people with established heart disease. It could be a scientific breakthrough, and a commercial one, too.
A lot will depend on full results that will be presented at a medical meeting later this year, and on price. The drug, Ilaris, costs $200,000 a year now, and a price cut could be necessary. For more than a decade, drug companies including GlaxoSmithKline and AstraZeneca have repeatedly funded giant clinical trials that cost hundreds of millions of dollars each to try to prove that medicines targeting inflammation in the arteries. None has previously worked unless it also had another effect, like lowering cholesterol.
It's also a big step for the scientist who led the trial: Paul M. Ridker, a cardiologist at the Brigham & Women's Hospital who has for years argued that inflamed arteries are is at least as big a factor in causing heart attacks and strokes as cholesterol. He pioneered (and patented) the use of a test for a blood test for C-reactive protein (CRP), a marker for inflammation, and conducted a giant study that showed that, in patients with high CRP, AstraZeneca's cholesterol-lowering drug reduced the risk of heart attacks and strokes.
With Crestor, researchers could argue that the benefit was not due to its ability to lower CRP, but because it lowers low-density lipoprotein, the "bad cholesterol." Scientifically, the big news with Cantos is that a drug that would not be expected to lower heart risk did, specifically by targeting a protein, IL-1b, that is involved in inflammation.
Currently, Ilaris is used in periodic fever syndromes and systemic juvenile idiopathic arthritis and generates only $250 million a year in sales, according to Timothy Anderson, a pharmaceuticals analyst at Bernstein Research. He says it lists at $200,000 a year in those indications. However, it is dosed monthly. In the new clinical trial, it was be given four times a year, yielding a price of about $60,000 at current costs.
Still, at $60,000 a year, the drug would cost four times more than the new cholesterol drugs, known as PCSK9 inhibitors, made by Amgen and the partnership of Regeneron and Sanofi. At these prices, these drugs have failed to sell, even after data in March that Amgen's drug, Repatha, can prevent heart attacks and strokes. Lately, cardiovascular drugs, once the industry's best sellers with blockbusters like Pfizer's Lipitor and Novartis' Diovan, have found themselves in a commercial death valley. Novartis's own Entresto, shown in a large study to prevent deaths in heart failure, a weakening of the heart due to heart disease, has also been a flop so far.
For Ilaris, Novartis may need to cut what it charges. But Anderson, the Bernstein analyst, wrote in a note to investors that the drug could be "a blockbuster at any price." More than 7 million patients in Europe and the U.S. could be eligible for the drug. Assuming a $15,000 price, like the PCSK9s, would yield a $60 billion market opportunity. If Novartis can capture just 10% of that, it would have $6 billion drug. A lot will depend on how big the benefit is and what side effects there are -- things that won't be revealed until full scientific results are available -- and how Novartis handles the pricing issues.
Ridker is also conducting a study, funded by the National Institutes of Health, that tests his heart inflammation hypothesis with an older arthritis drug, methotrexate. Those results are not expected for at least a year and a half.