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http://www.fdanews.com/dailies/device/3_58/news/67657-1.html
ANALYSTS PREDICT ACC WILL INFLAME STENT WOES
The American College of Cardiology (ACC) annual meeting next week will generate more controversy about the use of drug-eluting stents (DESs), a report from RBC Capital Markets says.
"We will be treated to a rehash of all the negative data on late-stent thrombosis" in the first-generation DES systems — Boston Scientific's Taxus and Johnson & Johnson's Cypher — said the report. "We expect this to be especially harmful in the near-term outlook for [Boston Scientific], which derives about 30 percent of its total revenues from Taxus."
The analysts also wrote they expect "a lot of bad press" for the current DES platforms to come out of the conference and noted that a rebound in DES penetration is not likely to happen soon.The report added that the COURAGE trial comparing interventional procedures, such as stenting, with drug therapy alone will probably generate more uncertainties about the role of DESs. It said Abbot Laboratories' Xience stent is "likely to steal the show," with data comparing it with the Taxus.
http://www.boston.com/business/ticker/2007/03/analysts_cloud.html
A year-long sales slump in drug-coated stents made by Boston Scientific Corp. and Johnson & Johnson has not reached a bottom.
Doctors are still weighing safety risks and data to help resolve the debate remain years away.
"The first quarter is going to be pretty ugly. I expect the market to be down 10 percent to 15 percent this year," said Jeff Jonas, a portfolio manager with Gamco Medical Opportunities Fund, which owns shares of J&J.
Drug-eluting versions of the mesh tubes used to open diseased arteries quickly supplanted the older bare-metal versions when introduced over three years ago, generating almost 90 percent of all stent sales by early 2006 and creating a nearly $6 billion market.
The drug coating that prevents vessels from re-clogging was hailed a medical breakthrough. Since then, however, follow-up data on patients revealed a small but serious risk of blood clots forming long after the stent is implanted.
Patients are switching back to bare-metal stents, which cost about one-third the price of drug-eluting models.
The percentage of patients receiving drug-coated stents has fallen to the low-70s, according to Boston Scientific.
"There has been no rebound in the market," the company's chief operating officer, Paul LaViolette, said this week.
J&J said drug-coated stents were used in 75 percent to 80 percent of U.S. cases in the fourth quarter. The company declined to provide current figures.
TIMING OF RECOVERY?
Analysts said the next generation of drug-eluting stents is likely to help the market stabilize as device makers promote their benefits.
New stents in the pipeline such as Abbott Laboratories Inc.'s Xience, Medtronic Inc.'s Endeavor and J&J's CoStar may eventually help turn the tide, said J.P. Morgan analyst Mike Weinstein.
"There's a case to be made that they potentially are safer. We can't say that for certain," he said.
However, clinical data assessing the blood clot risk in the devices won't be available for two to three years.
For now, drug-eluting stent use "is declining in some labs still," said Weinstein, suggesting first-quarter sales will be lower than the level in the fourth quarter.
Leerink Swann analyst Jason Wittes said he sees the drug-coated stent market reaching a bottom eventually, but not rebounding.
"All indications are that it (the market) continues to erode," Wittes said. "It looks like we're headed toward 60 to 65 percent penetration."
One reason doctors are using more bare-metal stents is that drug-coated stents require patients to stay longer on anti-clotting drugs such as Plavix and aspirin, and some patients don't comply because of the expense, said Dr. Stephen Green, associate director of the cardiac catheterization laboratory at North Shore University Hospital in Manhasset, New York.
Still, the downturn in drug-coated stent use will reverse, he said, as patients who have received bare-metal devices return for repeat procedures six to 12 months later due to re-clogging -- the issue the drug-coated versions were developed to address in the first place.
For now, recent government actions are keeping patients wary.
U.S. Food and Drug Administration officials are urging physicians to be more cautious in using the devices "off label" in patients with harder-to-treat conditions that are not indicated for the treatment. That practice is thought to account for about 60 percent of the stents implanted.
The agency that runs the U.S. Medicare program is also looking at how it pays for drug-coated stents following an FDA panel's warning in December that the devices are riskier in some patients than in others.
Earlier this month, the U.S. House Oversight and Government Reform Committee requested safety and marketing data from the stent makers as it begins a review of the products.
Many analysts are cautious on Boston Scientific's stock even as it hovers around 4-1/2-year lows near $15. They cite the slump in demand for drug-coated stents as well as for another major product -- its implantable defibrillators that manage irregular heartbeats.
Boston Scientific stock trades at about 14 times estimated 2008 earnings, compared with about 19 times for rival Medtronic. (Reuters)
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