West Coast Editor

NovaCardia Inc. plans to use most of the $48 million raised in a Series B financing to fund the ongoing Phase III trial with KW-3902, its A1-adenosine receptor antagonist for patients with congestive heart failure (CHF) who are undergoing diuresis.

"In acute heart failure in general, there's not much out there," said Brian Farmer, director of corporate development for San Diego-based NovaCardia, adding that the latest cash will "go a long way" toward finishing the Phase III program, which includes two ongoing studies and another to start later this year.

The last major approval news in the indication came more than five years ago, when the FDA cleared Fremont, Calif.-based Scios Inc.'s Natrecor (nesiritide), a recombinant form of human B-type natriuretic peptide, secreted by the heart as part of the body's response to heart failure. Johnson & Johnson, of New Brunswick, paid $2.4 billion in cash for Scios in 2003.

Farmer said KW-3902 "has a diuretic effect, but more importantly, preserves renal function," acting at kidney sites where adenosine otherwise would cause the organ to take up sodium and lead to more water retention.

"The drug interrupts that feedback loop," he said, which means KW-3902 could be used with diuretics such as Lasix (furosemide) from Paris-based Sanofi-Aventis Group for better effects without the renal problems.

CV Therapeutics Inc., of Palo Alto, Calif., also has researched A1-adenosine receptor antagonists for heart failure, including Adentri, which completed Phase II trials and is licensed to Cambridge, Mass.-based Biogen Idec Inc. The latter made news this month in the cardiac space by licensing a pulmonary arterial hypertension program from the Swiss firm mondoBiotech for $7.5 million up front and as much as $30 million in milestones. (See BioWorld Today, Sept. 15, 2006.)

At the center of the Swiss deal is Aviptadil, a synthetically made hormone lacking in patients with PAH who can end up with heart failure. Against CHF specifically, Sanofi is among the players, trying its luck with oral Multaq (dronedarone), the second-generation version of the gold standard treatment for chronic atrial fibrillation, Cordarone (amiodarone). But one Sanofi study in high-risk patients quit early due to high mortality.

NovaCardia recently offered details of data from Phase II trials with KW-3902 at the Heart Failure 2006 Congress in Helsinki, Finland, showing the compound worked well over a six-hour period and boosted hourly urine volume, with relatively preserved kidney function over a nine-hour period compared to placebo.

Kyowa Hakko Kogyo Co., of Tokyo, discovered intravenous KW-3902, and NovaCardia bought rights outside Asia and Japan in 2003 for undisclosed up-front money, milestone payments and royalties. NovaCardia has an oral version further back in the pipeline for long-term management of CHF.

Skyline Ventures, of Palo Alto, Calif., led the Series B, joined by InterWest Partners, of Menlo Park, Calif. Previous investors Montreux Equity Partners, also of Menlo Park, took part in the financing, along with Domain Associates, of Princeton, N.J.; Forward Ventures, of San Diego; and Versant Ventures. NovaCardia appointed to its board David Lowe, partner with Skyline, and Nina Kjellson, partner with InterWest.