Originally Published MDDI April 2004
|The Cordis Cypher stent was approved by FDA in April 2003.|
Jolting the lucrative drug-eluting stent market, Cordis Corp. (Miami), a Johnson & Johnson company, and Guidant Corp. (Indianapolis) have entered into a strategic alliance that will give each firm a stake in the other's drug-eluting stent technologies. The announcement came just before FDA approval of Boston Scientific Corp.'s (Natick, MA) Taxus drug-eluting stent, which some believe will become the U.S. market leader.
Cordis makes the Cypher sirolimus-eluting coronary stent, which in April 2003 became the first drug-eluting stent to receive FDA approval. Guidant also has been developing drug-eluting stents, but that program has suffered several setbacks. The technology enables the stent to apply a drug to the affected area to ward off restenosis, or reclosing of the coronary artery, which had been a significant problem. The market is expected to reach $3 billion by the end of 2004. According to market research firm Solucient (Evanston, IL), U.S. hospitals were using drug-eluting stents more than bare-metal stents by September 2003.
There has been much industry speculation that Cypher could lose significant market share to Taxus. FDA approval for Taxus came on March 5, 2004. (Full coverage of the Taxus approval will appear in the May 2004 edition of MD&DI.) While Cypher has won praise as a revolutionary technology, it has also received negative publicity over a few incidents of thrombosis. Some cardiologists, in addition, have criticized its deliverability. The Cordis-Guidant alliance, then, is seen by some as a move by both companies to improve their position relative to Boston Scientific. The announcement of the alliance came on February 24, 2004, less than two weeks before the Taxus approval.
“Cypher's [problems] were overstated a bit, but they do factor in” to the deal, said Patrick Driscoll, president of MedMarket Diligence (Foothill Ranch, CA).
The alliance has four major provisions:
• Guidant's sales and marketing team will copromote Cypher in the United States, with an option to do the same in Japan.
• Guidant will help Cordis develop a new version of Cypher using Guidant's Multi-Link Vision stent- delivery system.
• Guidant will give Cordis the option to cosell and comarket a fully bioabsorbable stent that Guidant is developing.
• Both firms have agreed to end all outstanding patent disputes between themselves, and to license certain patents.
Guidant said the deal does not affect plans for its Champion everolimus-eluting stent system. The firm hopes to launch that product in Europe in the first quarter of 2005 and in the United States in the first quarter of 2006.
“We are enthusiastic about expanding our product offering with a drug-eluting stent that has consistently demonstrated exceptional clinical results. The combination of our market-leading metallic stent (Multi-Link Vision) and an expansive product portfolio will allow Guidant to provide a full range of proven interventional therapies to physicians and patients,” said Dana G. Mead Jr., president of Guidant Vascular Intervention.
Guy J. LeBeau, MD, J&J Company Group Chairman with responsibility for Cordis operations, said that “incorporating Guidant's latest delivery technology promises to improve our current product line and give us entry into the next generation of drug-eluting coronary stent systems far earlier than originally anticipated.”
Separately, four days before the announcement of the Guidant-Cordis alliance, Guidant and Boston Scientific agreed to settle all outstanding litigation between them. Much of it related to drug-eluting stents and their delivery systems.
Driscoll said consolidation of the drug-eluting stent market, although not necessarily this quickly, was inevitable. The market also includes a fourth large player, Medtronic Inc. (Minneapolis).
“The market potential is impressive, but not unlimited,” he said. “And there is limited intellectual property and intellectual capital that can exist for the fundamental therapeutic benefit coming from drug-eluting devices. There is more to be gained jointly than independently. No doubt J&J and Guidant considered the competition from Boston Scientific and took it seriously. They decided to get what they can, while they can.”
Michael Drues, PhD, president of Vascular Sciences (North Grafton, MA), said Boston Scientific may capture market leadership “for cost, for efficacy, and for some problems Cordis had last year with acute thrombosis. I'm not convinced those were really stent-related, though we really don't know.”
The deal also makes sense from a technological standpoint, said Drues. “It says to me that Guidant believes that maybe Cypher is a better product overall than what they have been pursuing,” he said. “From J&J's perspective, the advantage is on the IP side. They make those conflicts go away. And maybe there are other technologies or IP positions that Cordis is interested in that Guidant already has.”
And, Drues emphasized, it is far too early to predict who will ultimately dominate the market. Unlike devices, the true efficacy of combination products can't be determined until they have been on the market for several years, he said.
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