Merck bulks up cardiovascular pipeline

The pharma giant has agreed to pay $350m (€256m), plus the amount of cash on hand at the time of closing, for NovaCardia, which has its headquarters in San Diego. The money will effectively pay for NovaCardia's lead drug candidate KW-3902, which is an adenosine A1 receptor inhibitor. The molecule is currently in Phase III trials in patients with acute congestive heart failure (CHF), although NovaCardia believes it could also be used to treat chronic CHF. CHF is most often caused by a weakening or stiffening of the heart muscle, which leads to a progressive loss in the heart's ability to pump blood effectively throughout the body. Renal function is an important determinant of the management and outcome of both acute and chronic CHF, and more than half of CHF patients have some degree of renal impairment. It is this area of the disease that NovaCardia's drug seeks to treat. KW-3902 is thought to block adenosine-mediated constriction of blood flow to the kidneys and inhibit reabsorption of salt and water by the kidney, thereby increasing urine volume and maintaining renal function in patients with CHF. NovaCardia claims that no other drug that dilates blood vessels acts on those in the kidney. Patients with CNF often require increasing doses of diuretics in order to reduce fluid overload caused by the deteriorating kidneys. "This acquisition continues to deliver on our strategy of targeted acquisitions in areas of unmet medical need in the therapeutic areas of strategic importance for Merck such as cardiovascular diseases,"​ said Richard Kender, vice president of business development and corporate licensing at Merck & Co. NovaCardia recently presented preliminary results from a pilot Phase III trial of KW-3902 at the European Society of Cardiology's Heart Failure Congress 2007. Compared to the placebo group, patients treated with the drug experienced a higher rate of improvement in dyspnoea (shortness of breath), which is a common symptom of CHF. KW-3902 also enhanced urine production by the kidney and slowed the deterioration of renal function that is often experienced by patients undergoing standard treatment. NovaCardia originally in-licensed the drug from Japan's Kyowa Hakko Kogyo, and so does not own its rights in Asia. Two Phase III trials are currently enrolling participants in the United States, Canada, Europe, Israel and Russia. "This acquisition gives Merck the possibility to expand its cardiovascular product pipeline into congestive heart failure, an area of important unmet medical need and significant burden to the healthcare system,"​ said Guy Eiferman, general manager of the atherosclerosis and cardiovascular franchise at Merck & Co. NovaCardia has decided to spin-out a new corporate entity to support clinical development of the company's second compound, K201 (JTV-519). The company claims that this drug has the potential to treat arterial fibrillation without the side effects associated with current therapies, such as life-threatening ventricular arrhythmias. The compound is a a multi-channel blocker and a ryanodine receptor stabiliser. NovaCardia was developing both oral and intravenous formulations of K201 to address acute and chronic arterial fibrillation, respectively. The IV formulation of the drug was set to start Phase II trials this year, having been licensed from Aetas Pharma in 2006.