Nuvelo to partner with Bayer on alfimeprase in deal worth up to $385 million

By E. Janene Geiss

Philadelphia, Jan. 5 - Nuvelo, Inc. said Thursday that it has entered into a collaboration with Bayer HealthCare AG to maximize the global development and commercialization of alfimeprase, Nuvelo's lead phase 3 product candidate.

Alfimeprase, a novel, first-in-class thrombolytic or blood clot dissolver that directly degrades fibrin, has been shown in clinical studies to provide rapid clot dissolution with a well-tolerated safety profile, according to a company news release.

Under the terms of the agreement, Nuvelo will retain all commercialization rights and profits from alfimeprase sales in the United States.

Bayer will commercialize alfimeprase in all territories outside the United States and will pay Nuvelo tiered royalties ranging up to 37.5% that reflect the late-stage development status and significant market potential of alfimeprase, officials said.

Nuvelo is eligible to receive up to $385 million in milestone payments, including a $50 million upfront 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, officials said.

Nuvelo will be responsible for 60% of the costs and will remain the lead for the design and conduct of the global development programs, officials said.

In 2006, Nuvelo said it expects to receive payments totaling $90 million, including the $50 million upfront payment and an additional $40 million in shared development expenses and a milestone payment for starting a phase 2 proof-of-concept trial in stroke.

"Bayer HealthCare proved to be the optimal partner based on its cardiovascular development and commercialization expertise, global reach and ability to provide significant resources to rapidly develop alfimeprase's full commercial potential," Ted W. Love, chairman and chief executive officer of Nuvelo, said in the release.

Nuvelo and Bayer said they will jointly engage in a comprehensive development plan to maximize the clinical and commercial potential of alfimeprase in the United States and abroad, as well as establish a worldwide franchise that addresses the unmet medical need of the large number of patients with diseases caused by blood clot formation.

Alfimeprase is being studied in phase 3 clinical trials for the potential treatment of acute peripheral arterial occlusion and catheter occlusion and may have utility in a wide range of additional thrombotic-related conditions such as stroke, deep venous thrombosis and myocardial infarction.

These disorders are among the most common causes of death and morbidity in the Western world, officials said.

"This phase 3 compound has the potential to be a significant addition to our cardiology/hematology business," Wolfgang Plischke, president of Bayer HealthCare's pharmaceutical division, said in the release.

"Thrombosis-related diseases are highly prevalent and alfimeprase's ability to rapidly dissolve clots in clinical trials conducted to date suggests 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," Plischke added.

The companies said they plan to expand beyond the current phase 3 programs and start additional clinical programs with alfimeprase in stroke and deep vein thrombosis.

A phase 2 program in stroke is expected to begin in the second half of 2006 and a phase 2 program in deep vein thrombosis is expected to begin in 2007, officials said.

Nuvelo is a San Carlos, Calif., pharmaceutical company focused on development and commercialization of novel drugs for acute cardiovascular and cancer therapy.

Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading companies in the health care and medical products industry based in Leverkusen, Germany.

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