Biotech Values

[DewDiligence]

CoStar R.I.P. — a real shocker. The Conor
stent platform per se is nominally still alive.

http://online.wsj.com/article/SB117853824065494360.html

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J&J Unit Says Stent Trial Fails

By JONATHAN VUOCOLO
May 7, 2007 8:14 a.m.

Johnson & Johnson's Conor Medsystems LLC said the CoStar II trial for its CoStar paclitaxel-eluting coronary stent failed to meet its primary endpoint, dealing another blow to the company's drug-coated stent business.

Conor will terminate clinical trials of the CoStar stent and won't conclude the submission of its premarket approval application to the U.S. Food and Drug Administration for the product.

The pharmaceutical giant's stent business will discontinue sale of the product through commercial partners in certain countries in Europe, Asia and Latin America where the CoStar stent is already approved, and will work with partners to remove the stents from inventory.

…CoStar is novel because it is designed to turn into a bare-metal stent over time. This type of stent is Conor's specialty. J&J recently bought Conor for $1.4 billion, or $33.50 a share. Results of CoStar II are a surprise, as analysts expected the results to be good and CoStar is held in high regard. CoStar II was the key trial to gather data to seek U.S. approval.

The results could be good news for Medtronic Inc. and Abbott Laboratories Inc., which are aiming to become the third and fourth companies to bring a drug-coated stent to the U.S. market, and could also boost stent-market leader Boston Scientific Corp.

…The CoStar II trial compared the CoStar stent with the Taxus Express paclitaxel drug-eluting stent, and was designed to demonstrate non-inferiority at eight-month follow-up with respect to major adverse cardiac events in patients with multivessel or single-vessel disease.

"While we are disappointed in these results, we remain optimistic about the ability of the novel Conor Medsystems reservoir platform to provide precise and controlled delivery of a therapeutic agent based on earlier proof of concept testing and trials," said Campbell Rogers, M.D., chief technology officer of the cardiovascular franchise. "Unfortunately, the dose of paclitaxel used in this trial was ineffective."

Conor will now watch the development of another drug, sirolimus, for use on coated stents. Sirolimus is the drug used on J&J's blockbuster Cypher drug-coated stent, which is made by J&J unit Cordis Corp.

J&J's drug-coated stent business's sales fell 27% to $530 million in the first quarter as doctors continued shifting business toward bare-metal devices.
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