Biotech firm Scios ( SCIO) said late Tuesday that U.S. drug regulators will approve its heart failure drug, Natrecor, although the company still has some hoops to jump through before the drug can hit the market.
The Food and Drug Administration issued an "approvable letter" for Natrecor, which will require Scios to complete negotiations on the drug's label, as well as pass an inspection of its manufacturing facility, before a final green light is given. The decision follows a thumb's-up from an FDA advisory committee May 25. Scios COO Richard Brewer, speaking on an analyst conference call, said the company was working quickly to clear up the final steps and that the drug's approval was "imminent." Natrecor is expected to hit pharmacy shelves in the third quarter. Natrecor's approval is a nice win for Scios, especially given the fact that the FDA has issued a spate of rejection notices in the past few months. Natrecor is the company's first approved drug, expected to generate sales of between $200 million and $300 million annually. Natrecor is given to patients suffering from acute flare-ups of congestive heart failure, a condition afflicting 5 million Americans. About 1 million of these patients require hospitalizations that cost the health care system $23 billion annually. Drugs like Natrecor could help patients suffering from life-threatening heart failure, and also reduce the cost of treatment. Right now, Natrecor stands alone because a rival drug from Genentech ( DNA) suffered a big setback in late-stage testing in April. Shares of Scios fell 60 cents, or 2.7%, to $21.25 Tuesday, in advance of the FDA decision. Shares of the company rose to $23.12 in after-hours trading.