Knobias Clip Report (09-25-2008) NUVO
Submitted By Knobias ClipReport
NUVO: Management Discusses Merger Agreement w/ARCA biopharma
By Fain Hughes, fhughes@knobias.com
Nuvelo, Inc. (NUVO) and ARCA biopharma, Inc., a privately-held biopharmaceutical company developing genetically-targeted therapies for heart failure and other cardiovascular diseases, announced that they have entered into a definitive merger agreement. The combined company will have a near-term commercial opportunity, Gencaro(TM)(bucindolol hydrochloride), as well as a mid-stage pipeline asset, novel short-acting anticoagulant NU172, to drive long-term growth.
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 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.
Under the terms of the definitive merger agreement, a wholly owned subsidiary of Nuvelo will be merged with and into ARCA and ARCA will become a wholly owned subsidiary of Nuvelo. Nuvelo will issue new shares of its common stock to ARCA common and preferred stockholders and assume outstanding options and warrants to acquire capital stock of ARCA. ARCA shareholders will own 67% of the common stock of the combined company on a fully-diluted basis. Current Nuvelo stockholders are expected to own approximately 33% of the common stock of the combined company.
Dr. Ted W. Love, Chairman and CEO of Nuvelo, commented in a conference call today, “We believe this complimentary merger provides the most immediate and long-term value to our shareholders. This deal allows us to transform the company into a last-stage company with multiple significant milestones and near-term commercialization opportunities, backed by a promising cardiovascular pipeline.”
Richard B. Brewer, President and CEO of ARCA, will lead the new management team. Dr Love will become a member of the board of directors. The combined company will be renamed ARCA biopharma, Inc. with a new ticker symbol.
Dr. Love added, “The new management team has the expertise to lead the development and commercialization of what we expect will be the first personalized cardiovascular drug, Gencaro.”
Mr. Brewer explained, “We expect that Nuvelo’s year-end cash balance and the additional funds provided by ARCA will provide adequate resources to last at least through 2009. We expect the combined cash position will fund opertions through the potential FDA cardio renal advisory meeting in early 2009 and regulatory decision for Gencaro in mid-2009.”
He concluded, “We have a very compelling product before the FDA and the promise of another in our pipeline. This merger provides the cash, people and facilities to build a leading cardiovascular company and enhance value for ARCA and Nuvelo shareholders.”
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