Medical Device Daily Associate

In a move that the company said is based primarily on clinical data, Abbott Laboratories (Abbott Park, Illinois) yesterday reported it is initiating the launch of the Xience V drug-eluting stent (DES) system and, concurrent with that, is scrapping its ZoMaxx DES program.

The company said that the Xience V, an everolimus-eluting DES, will be launched in the majority of European countries immediately, and it will focus its commercial, manufacturing and clinical DES resources exclusively on the successful launch of Xience V.

“We have conducted a thorough analysis of all available clinical data for both Xience V and ZoMaxx, and have concluded that Xience V is a significantly better product,” said Richard Gonzalez, president/COO of Abbott. “Following encouraging physician feedback from our pre-launch evaluation program in Europe, and given the positive Xience V data, we remain confident in our ability to achieve a leadership position in the drug- eluting stent market with the Xience V platform.”

Abbott’s move to scrap its homegrown ZoMaxx program was greatly enhanced by the acquisition of the Xience V product from Guidant (Indianapolis) after that company was acquired by Boston Scientific (Natick, Massachusetts) earlier in the year (Medical Device Daily, April 21, 2006) as part of a Federal Trade Commission-mandated divestiture.

The ZoMaxx system was comprised in part of polymer coating technology acquired when Abbott acquiredBiocompatibles International ’s(Basingstoke, UK) cardiovascular stent business for $245 million in 2002 (MDD, May 9, 2002). The device utilized zotralimus, a drug developed in-house by Abbott.

While it is still uncertain how much better the Xience V data truly is, more should be known soon when nine-month clinical data from ZOMAXX I, Abbott’s international ZoMaxx trial, is presented at the Transcatheter Cardiovascular Therapeutics meeting in Washington on Oct. 23.

Melissa Brotz, a company spokesperson for Abbott told Medical Device Daily that Xience V “has clearly superior clinical results. It is clearly the stronger platform that will offer the greatest benefits to patients. Once you look at the data and saw the clinical performance of both, then it made sense to us to focus the resources on one [system].”

That conclusion was backed by Larry Biegelsen, med-tech analyst with Prudential (New York), who in a report said, “It appears that the ZoMaxx data is inferior to that of Xience V.”

JP Morgan analyst Michael Weinstein wrote in a research report that the implications for Abbott were slightly negative. “Abbott goes from having two horses to ride in this race to one,” he said.

Weinstein added that the Abbott news also may have implications for stents made by Medtronic (Minneapolis), which uses zotarolimus, through a technology-swapping deal the companies cut in 2002.

Weinstein said poor results from the ZoMaxx trial might suggest a deficiency with the drug compound.

Abbott’s decision to drop ZoMaxx, however, assures that Medtronic would be the only company to launch a DES using the drug zotarolimus, eliminating the “risk that Abbott leapfrogs Medtronic with a similar, but better product,” Weinstein said.

Abbott recently reported that it is expanding its DES manufacturing capacity in Ireland to prepare for future launches in the U.S. and Japan.

Perhaps the real loser in all of this is Biocompatbles, which stands to lose significant royalty revenues on this news. As per its agreement with Abbott, the company stood to gain royalties in the range of 1%-5% on DES devices sold by Abbott containing its polymer coating technology.

Biocompatibles, which was expecting to start receiving royalties in the second half of 2007, maintained that the news will not hurt the company, at least in the short run.

“Abbott’s announcement has limited impact on 2006 and 2007 sales and no impact on cash in either year,” Biocompatibles said in a press release. “Commercialization of drug-eluting bead products remains the company’s principal focus,” it added.

Abbott said the European launch of Xience V came three weeks earlier than expected Originally, the company expected a second-quarter launch of the X stent in Europe but pushed that back to the third quarter after finding some products with quality problems.