Guidant's Xience V drug-coated stent has been recommended for approval in the European Union, and is expected to get the go-ahead for a launch in the next seven to 10 days.
Xience V contains the drug everolimus, which inhibits the tissue proliferation that is seen in the coronary vessels after a blocked vessel is cleared and a stent inserted to prevent the vessel walls from suddenly closing in.
With bare metal stents, this tissue growth could cause the vessel to block again in 15% to 20% of patients. The drug-eluting stents reduced this process, called restenosis, to almost zero, and all but consigned heart surgery to second-line use in coronary artery disease patients.
Xience will join Johnson & Johnson’s Cypher (sirolimus) and Boston Scientific’s Taxus (paclitaxel) products on the market for drug-eluting stents. Together, these two products have revolutionised the treatment of coronary artery disease, with close to 100% penetration in the USA, and 50-60% in European markets such as the UK. Yesterday, J&J said its Cypher sales had surpassed those of Taxus in the fourth quarter.
But with the efficacy of drug-coated stents in blocking tissue regrowth so high, attention has turned to other factors in the design of new products, such as ease of deployment and delivery, and making them smaller so they can be used in narrower vessels than the first-generation products. Guidant’s Xience V stent is made of cobalt chromium, a lighter, thinner material than that used in the current generation.
John Capek, president of the vascular intervention unit at Guidant, said the approval in Europe had come much sooner than expected.
“We are ramping up manufacturing and building inventory to supply our ongoing clinical trials and to support the European launch of Xience V in the second quarter."
The market for drug-eluting stents was expected to reach $5.5 billion by the end of 2005 and $6.3 billion by 2007.
A Phase III trial enrolling patients I the USA and Japan is about 70% enrolled and should meet its target for patient numbers later this quarter, according to Guidant. This trial will be used to support a filing for Xience V in the USA.
Guidant is currently at the centre of a tug of war between Johnson & Johnson and Boston Scientific, with the latter currently closer to bringing the firm home with a $27.2 billion bid on the table.
Both companies are interested in Guidant’s implantable defibrillator and pacemaker products, and Boston Scientific has said it will divest Guidant’s stent business to Abbott Laboratories if its offer is successful.