Washington Editor

Novartis AG is expanding its cardiovascular disease therapy pipeline through its acquisition of San Mateo, Calif.-based biotech Corthera Inc., giving the Swiss pharma giant exclusive worldwide rights to relaxin, a recombinant version of a naturally occurring human peptide currently in Phase III development as a treatment for acute decompensated heart failure (ADHF).

Basel, Switzerland-based Novartis, which currently markets the heart failure drug Diovan (valsartan), is acquiring all of privately held Corthera's outstanding shares for $120 million, with the biotech's current shareholders eligible to receive up to $500 million in clinical, regulatory and commercial milestone payments tied to relaxin's development and approval.

Under the deal, which is expected to close in the first quarter of 2010, Novartis will assume full responsibility for the development and commercialization of relaxin, with regulatory submissions in the U.S. and Europe planned for 2013.

ADHF, a condition that affects millions of people worldwide, is associated with chronic heart disease and impairs the heart's ability to pump blood from the lungs, which results in the lungs becoming overfilled with fluid, reducing oxygen uptake. Diuretics and vasodilators are the current standard-of-care treatment for the condition, but those drugs have been associated with renal impairment, low blood pressure and other adverse effects.

Relaxin, which is administered by infusion over 48 hours in the hospital setting, has been shown to have vasodilator effects, improve breathlessness and reduce cardiovascular morbidity and days in hospital.

Results of the completed Phase II portion of Corthera's multicenter, randomized, double-blind, placebo-controlled, parallel-group, international Pre-RELAX-AHF Phase II/III trial showed that patients administered relaxin with standard-of-care heart failure therapy had greater and longer-lasting relief of dyspnea, or shortness of breath.

The naturally occurring form of the polypeptide hormone is believed to orchestrate many of the maternal physiological responses to pregnancy, including renal function, decreases in systemic vascular resistance and increases in cardiac output, mediated largely by increased stroke volume, according to Corthera.

Novartis said the acquisition of Corthera is expected to further strengthen its position in the cardiovascular medicines space.

In addition to Diovan, an angiotensin receptor blocker, Novartis' cardiovascular portfolio includes Tekturna (aliskiren), a first-in-class direct renin inhibitor approved in the U.S. to treat hypertension. That drug, which is sold outside the U.S. as Rasilez, currently is in Phase III testing as a therapy for chronic heart failure.

Novartis' cardiovascular development pipeline also includes LCZ696, a single molecule dual-acting angiotensin receptor blocker-neprilysin inhibitor currently in Phase III development for systolic heart failure, and LCI699, a Phase II and first-in-class aldosterone synthase inhibitor being explored as a potential treatment for heart failure.

Novartis said relaxin also further complements its strategy to expand into the acute cardiology care setting. The Swiss firm currently is investigating elinogrel, an anti-platelet agent, in Phase II studies as a therapy to reduce the risk of heart attack and stroke.

Novartis said it has a hospital-based specialty sales force in place to maximize the commercial potential of its cardiovascular development portfolio.

"Relaxin will be an important addition to our expanding pipeline of novel development projects targeting cardiovascular disease," said Trevor Mundel, global head of development at Novartis.

"This transaction highlights relaxin's potential as an important treatment option for patients suffering from acute heart failure," said Corthera CEO Stan Abel. "We are extremely pleased to be entering into this transaction with Novartis, given their world-class capabilities and global leadership position in cardiovascular disease," he said in a statement.