Alfimeprase is currently in phase III development and has been shown in clinical studies to provide rapid clot dissolution with a well tolerated safety profile.
Under the terms of the agreement, Nuvelo will retain all commercialization rights and profits from alfimeprase sales in the US. Bayer HealthCare will commercialize alfimeprase in all territories outside the US and will pay Nuvelo tiered royalties ranging up to 37.5% that reflect the late-stage development status and significant market potential of alfimeprase.
Nuvelo is eligible to receive up to $385 million in milestone payments including a $50 million up-front cash payment, up to $165 million in development milestones and $170 million in sales and commercialization milestones over the course of the agreement.
In addition, Bayer will be responsible for 40% of the costs for global development programs. In 2006, Nuvelo expects to receive payments totaling $90 million, including the $50 million up-front payment and an additional $40 million in shared development expenses and a milestone payment for initiating a phase II proof-of-concept trial in stroke.
“Thrombosis-related diseases are highly prevalent, and alfimeprase’s ability to rapidly dissolve clots in clinical trials conducted to date suggest it may be the ideal complement to our range of products that address coagulation and thrombosis,” said Wolfgang Plischke, president of Bayer HealthCare’s Pharmaceutical Division. “We believe alfimeprase has the potential to transform the treatment of patients suffering from thrombotic-related disorders.”