Biotech Values

[DewDiligence]

Study Expected to Hit Sales of Drug-Eluting Stents

[The manifold press reports predicting a showing of no mortality benefit for angioplasty lead me to infer that the press always knows the results but is under an embargo not to report them explicitly.]

http://www.boston.com/business/healthcare/articles/2007/03/24

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Associated Press
March 24, 2007

Wall Street analysts and many doctors expect another potential setback for stent makers when results of a blockbuster study Tuesday answer whether an artery-opening procedure plus drugs is better than medication alone for lower-risk heart patients with chest pain.

It's the first big study to directly compare angioplasties with drug therapy alone as a way to prevent heart attacks and deaths in non-emergency cases.

If the research reaches the conclusion many analysts and doctors expect -- that angioplasty offers little or no lifesaving benefit over drugs for these patients -- the finding would be the latest dose of bad news for makers of stents such as Natick-based Boston Scientific Corp. The tiny mesh devices are used in most angioplasties to keep vessels open after blockages have been cleared.

After new-model drug-coated stents reached the market in 2003, the global stent market, including older bare-metal stents, grew from about $2 billion a year to about $6 billion in 2005.

But use has fallen since evidence emerged that drug-coated stents carry a slightly higher risk of triggering blood clots months or years later. Many doctors have returned to using bare-metal stents or doing bypass surgery instead of angioplasty until more is known.

The drug-coated stent market shrank last year and is expected to erode at a faster rate this year, due in part to anticipation of this study.

"This market went from zero to 100 mph, and now it's braking," said Citigroup analyst Matthew Dodds, who forecasts an 8 percent decline in stent sales this year, and slower market erosion through 2011.

For drug-coated stent makers such as Boston Scientific and Johnson & Johnson, the shift has been costly, since drug-coated models cost around $2,100 apiece compared with about $850 for bare-metal versions introduced more than a decade ago.

The big study to be reported on Tuesday compared angioplasty plus optimal heart medications to medications alone. Results are to be presented at the American College of Cardiology's annual meeting in New Orleans.

Pointing to earlier smaller studies, industry analysts and doctors believe angioplasties will be on the losing end.

"I'd be very surprised if there was a reduction in mortality," said Dr. William Maisel, a cardiologist at Beth Israel Deaconess Medical Center . "I suspect the bottom line we will be left with is that both options (angioplasty versus drugs only) are reasonable."
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