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news.Nuvelo and Bayer HealthCare's anti-clot drug alfimeprase for acute peripheral arterial occlusion did not meet its primary endpoint of avoidance of open vascular surgery within 30 days of treatment in a phase III trial.
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The companies also said that a phase III trial in catheter occlusion did not meet the endpoint of restoration of function at 15 minutes. These trials did not meet key secondary endpoints.
The companies have temporarily suspended enrollment in the ongoing phase III trials until further analyses and discussions with outside experts and regulatory agencies are completed.
“We and our partner Bayer will conduct further analyses and have discussions with the Data Safety and Monitoring Board members, outside experts and regulatory authorities to determine how to proceed with the development of alfimeprase, including the possibility of alternative dosing and delivery,” said Dr Ted Love, chairman and CEO of Nuvelo.
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 US and will pay Nuvelo tiered royalties. Nuvelo retains commercialization rights in the US and will remain the lead for the design and conduct of the global development programs.