ARCA’s Phase III heart failure treatment is expected to obtain FDA feedback by May 2009.
Nuvelo entered into an agreement to purchase ARCA biopharma to gain Gencaro, a late-stage candidate for heart failure. 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.
Option and warrant holders will have the right to acquire approximately 67% of the common stock. Current Nuvelo stockholders are expected to own approximately 33% of the common stock of the combined company. ARCA will merge with Nuvelo’s wholly owned subsidiary, Dawn Acquisition Sub.
The transaction is expected to close by the end of this year or early 2009. The cash position of the new company is expected to fund operations at least through 2009, according to Nuvelo. This should take care of the potential FDA advisory meeting in the first half of 2009 and anticipated regulatory approval for Gencaro in mid 2009.
Gencaro is a genetically targeted beta-blocker with vasodilating properties for the treatment of heart failure. The NDA for this drug has been accepted for review by the FDA with a PDUFA date of May 31, 2009.
The combined entity will also have a mid-stage candidate, NU172, a short-acting anticoagulant being tested in indications such as coronary artery bypass graft (CABG) surgery, kidney dialysis, and vascular surgical and coronary interventions. A Phase II trial evaluating NU172 in CABG is expected to begin in the fourth quarter of 2008 or the first quarter of 2009. Additionally, Nuvelo is developing NU206 as a treatment for gastrointestinal diseases including cancer therapy-induced mucositis and inflammatory bowel disease in addition to bone disease and wound healing.