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ARCA Biopharma, Inc.

Drug Names(s): Alfimeprase

Description: Alfimeprase is an atypical thrombolytic. Rather than dissolving blood clots by activating plasminogen (like tPA-based thrombolytics), alfimeprase is a modified recombinant fibrolase – an enzyme that degrades fibrin (part of the molecular latticework of a blood clot). Pre-clinical studies suggest that alfimeprase’s biological activity has the potential to translate into clinical trial efficacy in terms of more rapid clot dissolution and more rapid drug clearance. This activity could lead to use not only in occlusive peripheral arterial disease, but also in myocardial infarction and venous thromboembolism.

Technically, no FDA approved medical therapies exist for occlusive peripheral arterial disease, so alfimeprase has received an orphan drug designation. If more rapid clearance translates into less bleeding risk than with contemporary agents, alfimeprase’s risk/benefit profile in occlusive peripheral arterial disease – more difficult to achieve than in the other thrombolytic indications – may prove favorable for this indication. If so, other thrombolytic indications would soon follow.

Deal Structure: In January 2002, Amgen entered into a collaboration agreement with Nuvelo (then known as Hyseq Pharmaceuticals, Inc.) for the development and commercialization of alfimeprase. Under the terms of this agreement, Nuvelo was responsible for leading all clinical development activities for alfimeprase and Amgen was responsible for leading manufacturing activities. Amgen had the option to lead commercialization activities in which both companies could participate. Following completion of the Phase 2 alfimeprase trial in acute PAO, the agreement also allowed Amgen to transition the alfimeprase collaboration with Nuvelo into a licensing arrangement under which Amgen would grant Nuvelo worldwide rights to alfimeprase. Amgen has exercised its right under the agreement and will grant Nuvelo worldwide rights to develop and commercialize alfimeprase.

In November 2004, Nuvelo gained worldwide rights to develop and commercialize alfimeprase from Amgen in exchange for payment of previously...See full deal structure in Biomedtracker

Partners: Amgen, Inc.

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