Overview of Combined Company
Cardiovascular Product Portfolio
-- Gencaro(TM), (trade name pending FDA approval), a Near-term Commercial Product Opportunity: Gencaro is a genetically-targeted beta-blocker with unique vasodilating properties for the treatment of heart failure. Phase 3 data showed statistically significant results for major clinical endpoints including combined heart failure hospitalization and all-cause mortality in the entire patient population studied, and even greater efficacy in a genetically targeted subpopulation, highlighting its differentiated profile and efficacy in heart failure patients. The New Drug Application (NDA) for Gencaro has been accepted for review by the U.S. Food and Drug Administration (FDA) with a PDUFA date of May 31, 2009. Pending a positive regulatory decision, ARCA expects to commercialize Gencaro in the first half of 2010.
-- NU172, a Catalyst for Long-term Growth: NU172 is a short-acting anticoagulant that is being tested as a potential new therapy in indications where heparin and protamine are the current standard of care, such as coronary artery bypass graft (CABG) surgery, kidney dialysis and a variety of vascular surgical and coronary interventions. A Phase 2 trial evaluating NU172 in CABG patients is expected to begin in the fourth quarter of 2008 or the first quarter of 2009.
Resources to Provide Solid Foundation
-- The cash position of the combined company at the close of the transaction is expected to fund operations at least through 2009, including the potential FDA advisory meeting in the first half of 2009, and anticipated regulatory approval for Gencaro in mid 2009.
Experienced Leadership Capable of Driving Value
-- Chief Executive Officer: Richard B. Brewer, current president and
CEO of ARCA, former president and CEO of Scio
|SOURCE Nuvelo, Inc.|
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