Johnson & Johnson launches the stent war

Pharma giant Johnson & Johnson (NYSE: JNJ) has launched a multi-pronged offensive to grab the leadership position in the drug-coated stent market from speciality stent maker Boston Scientific Corp (NYSE: BSX). While J&J was first to introduce its Cypher drug eluting stent through group company Cordis in 2003, Boston Scientific captured two-thirds of this market from Johnson & Johnson last year after introducing its Taxus stent.

A stent is a small, expandable wire mesh tube, used to prop open arteries after they have been cleared of blockages through a procedure known as balloon angioplasty. The new coatings reduce the build-up of blood clots and scar tissue that can re-block the arteries and require procedure to be repeated.

Boston Scientific''s core product is its drug-coated cardiac stents. Market figures indicate that the Taxus stent has a market share of 60 to 65 per cent, with the remainder going to the Cypher stent. Johnson & Johnson put fourth-quarter US Cypher sales at $307 million, or 38 per cent of the total US market. The New Jersey-based J&J started its offensive last year with a price war, and has gone on this year to a ''scientific'' offensive to prove that its Cypher stent is better than market leader Taxus.

J&J''s Cypher stent was retailing at $2,350 in the fourth quarter of last year, a 19 per cent drop from the $2,900 at which the devices sold in the first quarter of 2004, when Boston Scientific''s Taxus stent debuted for $2,675. Since then, the Taxus stent''s price has dropped only 4 per cent to $2,575. Boston Scientific says it will not get into a price war with J&J, as stents are not chosen on the basis of price alone. However, if J&J continues to lower its prices, as most experts expect, Boston Scientific may be forced to stay comparable, if not competitive. In comparison, a bare metal stent costs just $1,000, but is established to be far less effective.

The scientific offensive came to a head at the American College of Cardiology annual scientific session in Orlando, Florida, where the eight-month ''Reality Trial'', sponsored by J&J and conducted by Marie-Claude Morice, head of interventional Cardiology at the Institut Hospitalier Jacques Cartier, Massy, France, was presented in early March 2005. The trial report said that the Cypher Sirolimus-eluting coronary stent results in significantly fewer blood clots at the stent site (stent thrombosis) than Boston Scientific''s Taxus Paclitaxel-eluting coronary stent. Stent thrombosis is a severe complication of stenting and can result in heart attacks and death.

"Incidence of stent thrombosis was 78 per cent lower with the Cypher stent than with the Taxus Stent," said Dr Morice. But this claim has come in for criticism from Boston Scientific and Vancouver-based Angiotech Pharmaceuticals Inc (NASDAQ: ANPI), developer of paclitaxel, the drug that coats the Taxus stent. While that may be expected, the study has met with a largely cynical reaction from the community of cardiac surgeons, most of whom do not think it shows much difference between the two stents.

The Reality Trial is a prospective, randomised study involving 1,386 patients at 90 hospital and centres in Europe, Latin America and Asia. Patients were included if they had up to two new (de novo) lesions with a primary lesion of at least 15 mm in length in their small cardiac arteries (2.25 to 3.0 mm in diameter). On average, patients receiving the Cypher stent had 1.91 stents, while those receiving Taxus had 1.94 stents. It said patients who received the Cypher stent had a significantly larger vessel diameter inside the stent after eight months of follow-up, which is important because the vessel diameter determines the amount of blood that is delivered to the heart muscle.

For most cardiologists J&J''s lower prices haven''t stopped them from using Taxus stents. Most of them say that Taxus stents are easier to place in blood vessels. Though one of the findings of the Reality Trial was that both stents are equally deliverable, surgeons aren''t buying it… as yet.

What struck a really positive blow for J&J was an independent Swiss study called Sirtax, which showed a clear benefit for Cypher. The Sirtax data, combined with a small, 250-patient study of diabetics that also showed a benefit for Cypher, could finally give J&J a leg up in the drug-coated stent market. The study was funded with public money, not by a pharmaceutical company, and was presented by Stephan Windecker from the University Hospital in Bern, Switzerland.

Sirtax showed that in slightly more than 1,000 patients, J&J''s Cypher stent significantly outperformed Boston Scientific''s Taxus. In the trial, patients who received Taxus instead of Cypher were 80 per cent more likely have a serious cardiovascular event or surgery. Taxus patients'' arteries re-narrowed more often than those on Cypher. The Sirtax study took all comers, no matter how sick, while J&J researchers selected its patients for Reality. Sirtax included enough very ill patients so that small advantages were easier to see. But like all studies, there is another side. Boston Scientific pointed out that the Sirtax research seemed to show its stents have the advantage regarding blood clots.

Muddying the waters for both sides, Medtronic (NYSE: MDT) presented data on its own stents, which could be available in 2007. The general verdict at this stage of the stent wars is that J&J is holding ammunition to restart a marketing war that until now had clearly been won its rival. That doesn''t mean Boston Scientific will suddenly lose all its share of the stent market, but J&J may be able to win back a fair bit.

Another J&J-sponsored study presented at the session - The Arterial Revascularisation Therapy Study II (ARTS II) - compared results of using drug eluting stents to bypass surgery. This was a follow-up to ARTS I, which compared the results of bare metal stents to those obtained with bypass surgery.

Principal investigator Professor Patrick Serruys of the Thoraxcenter, Erasmus Medical Centre, Rotterdam, Netherlands, said that percutaneous procedures using the Cypher stent may be as effective as bypass surgery and much less invasive. ARTS II represents one of the most complex patient populations studied to date with any drug-eluting stent. An average of 3.7 stents were implanted per patient.

The composite rate for death, stroke, and heart attack were significantly lower in ARTS II compared with both the surgical and angioplasty-with-stent results in ARTS I. "The findings for ARTS II are particularly impressive because, compared to the ARTS I population, substantially more ARTS II stent patients had triple vessel disease (54 per cent, versus 30 percent in the surgical and 27 per cent in the stent arm of ARTS I). Besides, a higher number of patients had significant risk factors such as diabetes, high blood pressure and high blood triglycerides," said Professor Serruys.

ARTS II includes 607 patients from 45 European centres treated with a Cypher stent. Investigators compared the findings for these patients to those from the ARTS I trial, which included 602 patients treated with coronary bypass surgery and 600 treated with a bare metal stent.