ABT Xience Stent Bests Taxus in Head-to-Head Study
[This presents an amusing dilemma for BSX because BSX acquired the right to co-market Xience as part of its acquisition of Guidant and ABT’s simultaneous acquisition of Guidant’s vascular business to satisfy anticompetitive concerns (#msg-10772808). BSX hoped that Xience would be good, but they probably did not want Xience to be so good that it would be considered better than BSX’s own Taxus.
BARCELONA, Sept 5 (Reuters) - A new drug-coated stent from Abbott Laboratories Inc <ABT> proved more effective in clinical tests than Boston Scientific Corp's <BSX> market-leading Taxus, researchers said on Tuesday.
A 300-patient trial, presented at the World Congress of Cardiology, found there was significantly less tissue regrowth inside coronary arteries when patients were given Abbott's Xience stent than when they had Taxus implanted.
Drug-coated stents -- tiny, wire-mesh tubes used to prop open clogged blood vessels -- are designed to prevent scarring and tissue regrowth in arteries, a process known as restenosis, although recently controversy has grown over their long-term safety.
Six months after treatment, the amount of so-called "in-stent late loss" in Xience patients was 0.11 millimetres against an average 0.36 mm for Taxus. Late loss is a measure in the change of blood vessel diameter following insertion of a stent.
The head-to-head study had been designed simply to show that Xience, which uses the popular Vision bare-metal stent as its backbone, was as good as Taxus. The superiority finding is therefore a boost for Abbott.
The U.S. company plans to launch Xience next month in Europe, where it has already received a CE mark of regulatory approval.
"The stent system's impressive safety and efficacy data, combined with its highly deliverable platform, will make Xience an attractive new drug-eluting stent for physicians and patients in Europe," said the trial's principal investigator, Professor Patrick Serruys of Erasmus University Hospital, Rotterdam.
Michael Weinstein, an industry analyst with JP Morgan, said Xience had performed exceptionally and the results boded well for the product. He predicted a modest positive impact on Abbott's results in the fourth quarter from European sales, which would then ramp up in 2007.
U.S. APPROVAL AWAITED
Abbott, which acquired Xience when it bought the vascular interventions business of Guidant, hopes to win U.S. approval for Xience early in 2008, although analysts at Merrill Lynch think a late 2007 green light is a possibility.
Abbott also has another coated stent called ZoMaxx in development and Merrill believes the company's worldwide revenues from drug-eluting stents by 2009 could total $1.6 billion, or 5 percent of group revenue.
Under a deal it cut with Abbott, Boston Scientific will also be able to sell a private label version of the Xience stent, although the late loss superiority of the new stent over Taxus could pose something of a dilemma. Some analysts believe Boston Scientific's own label version of Xience, which will be manufactured by Abbott but marketed as Promus, may cannibalise sales of Taxus. [No kidding!]
However, Boston's Scientific chief medical and scientific officer, Donald Baim, said he expected Johnson & Johnson's <JNJ> rival device Cypher to suffer more. "We see, in our market modelling, much more erosion of Cypher share than Taxus market share," he told Reuters. Promus will be launched shortly after Xience, he added.
Debate over the potential for drug-coated stents to cause blood clots has dominated this week's meeting in Barcelona, following a meta analysis of past clinical trials suggesting they may more pose a higher risk than older bare-metal ones.
Serruys said there was one case of late stent thrombosis in the group of patients on Xience and one in those given Taxus during the clinical trial, but it was too early to draw any conclusions over relative risk.
Late stent thrombosis, which frequently triggers heart attacks and death, is seen as a particular problem a year or more after treatment, when patients will have stopped taking the blood-thinning drugs they are given following stent implantation. <<
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