Bayer HealthCare AG (BHC) has entered into a collaboration agreement with Nuvelo Inc. for the global development and commercialization of a novel thrombolytic or blood clot dissolver which is currently in clinical phase III development. The compound, alfimeprase, directly degrades fibrin and has been shown in clinical studies to provide rapid clot dissolution.
According to the company release, because of the late-stage development status of alfimeprase, Nuvelo is eligible to receive up to $385 million in milestone payments including a $50 million up-front cash payment. Bayer HealthCare will be responsible for 40 percent of the costs for global development programs. Nuvelo will be responsible for 60 per cent of the costs and will retain the lead for the design and conduct of the global development programs. Bayer HealthCare will commercialize alfimeprase in all territories outside the United States and will pay Nuvelo sales-dependent tiered royalties ranging up from 15.0 per cent to 37.5 per cent. Under the terms of the agreement, Nuvelo will retain commercialization rights in the United States.
"This phase III compound has the potential to be a significant addition to our cardiology/haematology business," Wolfgang Plischke, President of Bayer HealthCare's Pharmaceutical Division said adding, "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. We believe alfimeprase has the potential to transform the treatment of patients suffering from thrombotic-related disorders."
Alfimeprase is an enzyme produced by recombinant DNA technology that rapidly dissolves blood clots through a unique mechanism of action by directly degrading fibrin, a protein that provides the scaffolding for blood clots. The product is currently being studied in phase III clinical trials for the potential treatment of acute peripheral arterial occlusion (PAO) and catheter occlusion (CO), and may have utility in a wide range of additional thrombotic-related conditions such as stroke, deep venous thrombosis (DVT) and myocardial infarction.