BAYER, NUVELO ANNOUNCE TWO TRIALS MISS PRIMARY ENDPOINTS

Nuvelo and Bayer HealthCare have announced top-line data demonstrating that the Phase III clinical trial of alfimeprase in acute peripheral arterial occlusion (PAO), known as NAPA-2, did not meet its primary endpoint of avoiding open vascular surgery within 30 days of treatment. The companies also announced that the Phase III trial in catheter occlusion (CO), known as SONOMA-2, did not meet the endpoint of restoration of function at 15 minutes. These trials did not meet key secondary endpoints. In addition, the companies announced that they have temporarily suspended enrollment in the ongoing trials until further analyses and discussions with outside experts and regulatory agencies are completed.

NAPA-2 was a randomized, double-blind study that compared the efficacy and safety of 0.3 mg/kg of alfimeprase with placebo in 300 patients worldwide. The study's primary endpoint was avoidance of open vascular surgery within 30 days of treatment. A variety of secondary endpoints were also evaluated, including restoration of arterial blood flow, incidence of bleeding and pharmacoeconomic endpoints.

SONOMA-2 was a randomized, double-blind trial comparing the efficacy and safety of 3 mg of alfimeprase with placebo in 303 patients with occluded central venous catheters. The study's primary endpoint was restoration of function to the occluded catheter in 15 minutes.

Nuvelo and Bayer have a global collaboration for the development and commercialization of alfimeprase. Under the terms of the agreement, Bayer will commercialize alfimeprase in all territories outside the United States and will pay Nuvelo tiered royalties. Nuvelo retains commercialization rights in the United States and will remain the lead for the design and conduct of the global development programs.