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Biotech / Medical : CVAS-an interesting california-based biotech company here -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (125)	2/4/2004 11:01:56 PM
From: keokalani'nui	Respond to of 126

Nuvelo Licenses rNAPc2, a Novel Anticoagulant, From Dendreon Wednesday February 4, 8:43 pm ET Nuvelo Adds Phase 2 Product Candidate to Its Cardiovascular Pipeline SUNNYVALE, Calif. and SEATTLE, Feb. 4 /PRNewswire/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced a worldwide licensing agreement with Dendreon Corporation (Nasdaq: DNDN - News) for Dendreon's novel anticoagulant, recombinant nematode anticoagulant protein c2 (rNAPc2) and all other rNAPc proteins. Under the terms of the agreement, Nuvelo will pay to Dendreon in cash and common stock an upfront payment of $4 million. In addition to the upfront payment, the agreement provides for milestone payments for development and royalties upon the commercialization of rNAPc product candidates. Nuvelo will own worldwide rights to all indications for rNAPc products. No additional financial terms were disclosed. "Given Dendreon's focus on oncology product development, we are pleased to license the rNAPc2 program to Nuvelo while maintaining the downstream potential for this product candidate through a potential royalty stream," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "We believe Nuvelo has the capabilities to effectively advance rNAPc2." "rNAPc2 is a natural fit for Nuvelo," said Dr. Ted W. Love, president and chief executive officer of Nuvelo. "The addition of this molecule strengthens our cardiovascular portfolio of product candidates and our promising research pipeline." The novel anticoagulant rNAPc2 is a naturally occurring protein that was originally isolated from hookworms and is currently manufactured as a recombinant protein for clinical use. The anticoagulant effect of rNAPc2 results from its apparent ability to block the Factor VIIa/Tissue Factor protease complex, which is responsible for the initiation of the process leading to blood clot formation. Unlike aspirin, heparin and antiplatelet agents, which exert their effects at later stages of the blood coagulation cascade, rNAPc2 blocks the first step in the clotting cascade, inhibiting coagulation before it starts. Currently, a multi-center, Phase 2a study to investigate the safety and efficacy of rNAPc2 in patients with acute coronary syndromes (ACS) is being conducted with the TIMI Study Group led by Dr. Eugene Braunwald of Brigham and Women's Hospital and Harvard Medical School. Nuvelo plans to complete the Phase 2a study and based on the data, further evaluate how to move clinical development forward. ACS is a potentially life threatening heart condition that usually occurs when an atherosclerotic plaque ruptures in one or more arteries of the heart. This rupture triggers a series of biochemical events know as the blood coagulation cascade, which results in the formation of a blood clot. Blocking the flow of blood through the heart, the clot deprives heart tissues of oxygen, causing chest pain. The use of rNAPc2 may significantly reduce the risk of heart attack or death in patients suffering from ACS. In both the United States and Europe, ACS accounts for more than 1 million hospitalizations annually. Despite current treatments, a significant proportion of patients still experience recurrent angina, myocardial infarction or death. "Given the significant number of patients with acute coronary syndromes who continue to experience poor outcomes, there is a clear need for better anticoagulant therapy," said Dr. Love. "rNAPc2 has the potential to offer safer, more effective anticoagulation, reducing bleeding side-effects and the formation of unwanted blood clots." To date, rNAPc2 has been shown to be well tolerated in over 500 patients and healthy volunteers in several Phase 1 and 2 studies. A Phase 2 study for the prevention of deep vein thrombosis (DVT) demonstrated that rNAPc2 appears to reduce the risk of developing DVT and related complications by over 50% compared to the current standard therapy for patients undergoing total knee replacement surgery without compromising safety. A second Phase 2a study demonstrated that rNAPc2 was well-tolerated when added to standard therapy with unfractionated heparin, aspirin and clopidogrel in patients undergoing elective percutaneous coronary intervention (PCI). This study also demonstrated that rNAPc2 suppresses the formation of thrombin for at least 36 hours following a single administration, compared to standard therapy alone, in which thrombin generation continued unabated. Other potential indications under evaluation include orthopedic and vascular surgery, Ebola and cancer. A recent study published in The Lancet suggests rNAPc2 may be effective in the treatment of the Ebola virus infection. In addition, preclinical studies published in Cancer Research showed that blocking the protease complex Factor VIIa/Tissue Factor prevented the growth of primary and metastatic tumors in animal models.