05 January 2006 - Bayer HealthCare and Nuvelo Enter Into Collaboration Agreement for Global Development and Commercialization of Alfimeprase
Bayer HealthCare To Commercialize in All Territories Outside the U.S. / - Nuvelo Retains U.S. Commercialization Rights and Will Receive Milestone Payments of up to $385 million Leverkusen, Germany and San Carlos, CA - Bayer HealthCare (BHC) today announced that it has entered into a collaboration agreement with Nuvelo Inc. (Nasdaq: NUVO) 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. "This phase III compound has the potential to be a significant addition to our cardiology/hematology business," said Wolfgang Plischke, President of Bayer HealthCare's Pharmaceutical Division. "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." 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 percent 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 percent to 37.5 percent. Under the terms of the agreement, Nuvelo will retain commercialization rights in the United States. “In 2005 we articulated our strategy to pursue a partnership for alfimeprase that would maximize its commercial potential and allow us to accelerate commercialization outside of the U.S. while establishing our own domestic sales force,” said Ted W. Love, M.D., chairman and chief executive officer of Nuvelo. “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.” 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. These disorders are among the most common causes of death and morbidity in the Western world. The companies plan to expand beyond the current phase III programs and initiate additional clinical programs with alfimeprase in stroke and DVT. Bayer HealthCare The company combines the global activities of the divisions Animal Health, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Since January 1, 2006 the new Pharmaceutical Division consists of the former Biological Products and Pharmaceutical Division and now comprises three business units: Hematology/Cardiology, Oncology and Primary Care. Bayer HealthCare's aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating diseases. About Nuvelo This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the health care and medical products industry based in Leverkusen/Germany. In 2004, the Bayer HealthCare subgroup generated sales amounting to some 8.5 billion Euro. Bayer HealthCare employed 35,300 people worldwide in 2004.
Nuvelo, Inc. is dedicated to improving the lives of patients through the discovery, development and commercialization of novel drugs for acute cardiovascular and cancer therapy. Nuvelo's clinical pipeline includes alfimeprase, a direct-acting thrombolytic in phase III trials for the treatment of thrombotic-related disorders, and rNAPc2, an anticoagulant that inhibits the factor VIIa and tissue factor complex that is currently in phase II clinical development for acute coronary syndromes. Nuvelo is also progressing preclinical development candidate, NU206, for the potential treatment of chemotherapy/radiation therapy-induced mucositis from its proprietary research programs. Nuvelo expects to leverage its expertise in secreted proteins and antibody discovery to further expand its pipeline and create additional partnering and licensing opportunities.
