Scios' Natrecor gets unanimous backing for use in acute heart failure

Scios moved a step closer to launching its new drug Natrecor(nesiritide) in the USA for the treatment of patients with acute congestive heart failure after receiving a unanimous vote of support from the US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee.

Scios' share price has been in the ascendancy in recent months on optimism regarding the prospects for Natrecor, which looks set to be the company's first marketed product and the first new drug to be approved for CHF in the USA in more than a decade. However, Natrecor has been down a long and winding road to reach this stage, having entered development in the early 1990s, and in 1999 fell at the first regulatory hurdle when the FDA rejected the company's New Drug Application for the drug, despite a narrow vote by the panel in favor of approval, on the grounds that Scios had not conclusively demonstrated either its safety or efficacy (Marketletter May 3, 1999).

Scios initiated a new trial (VMAC) to try to address these concerns, but a further headache ensued when partner Bayer pulled out of its collaboration on the product shortly afterwards. However, in the light of the new development, this was probably a positive move for Scios, allowing it to renegotiate more favorable financial terms for the product. If full US approval is granted, the company hopes to launch the drug in July via a commercialization agreement with Innovex, a unit of Quintiles Transnational Corp. Analysts have suggested that Natrecor could achieve sales in excess of $300 million a year at peak.