Yesterday, Johnson & Johnson (JNJ) announced the initiation of enrollment in the Cypress study (CYPherR for Evaluating Sustained Safety), which is designed to assess clinical outcomes in a wide range of patients suffering from coronary artery disease and taking dual anti-platelet therapy after receiving a Cypher Sirolimus-eluting Coronary Stent. The study, which will enroll approximately 2,000 patients, will be conducted at 200 centers throughout the U.S.

Cypress will provide data for the clinical evaluation of the company’s new NEVO Sirolimus-eluting Coronary Stent in the NEVO III trial. NEVO III is a single-arm trial which is expected to serve as the pivotal trial for the pre-market application (PMA) submission in the U.S. NEVO III will be conducted with approximately 1,200 patients in the United States and Canada.

The Cypress trial is divided into two phases. In Phase I, patients will receive the Cypher Stent coupled with 12 months of dual antiplatelet therapy with a thienopyridine — clopidogrel or prasugrel — and aspirin.

Patients treated with 12 months of dual antiplatelet therapy in the earlier phase and who remained free from heart attack, stroke, the need for another procedure (revascularization), stent thrombosis and major bleeding, will be eligible to participate in the second phase of the study. Patients will be randomized to receive either placebo or an additional 18-months of thienopyridine therapy. All subjects will continue the aspirin therapy.

The company’s Cordis division is the manufacturer of the Cypher sirolimus drug-eluting stent. In recent quarters, ex-U.S. market share has been declining due to the introduction of competing products by Abbott (ABT) and Medtronic (MDT).

We believe that the company’s diverse and deep product mix, lack of cyclicality, strong financial position and consistent record of earnings growth will insulate it from a prolonged economic downturn. We are Neutral on the shares.
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