By Brady Huggett
Scios Inc. finally got what it¿s been waiting for ¿ an approvable letter from the FDA for Natrecor as an intravenous treatment for patients with acutely decompensated congestive heart failure.
Scios released the news after the market closed Tuesday. The company said the FDA is prepared to approve the new drug application following the finalization of Natrecor labeling and completion of a pre-approval inspection. The FDA¿s Cardiovascular and Renal Drugs Advisory Committee unanimously recommended approval of Natrecor in May. (See BioWorld Today, May 29, 2001.)
Natrecor has had a difficult passage. The FDA denied it in April 1999 after an advisory panel barely recommended it in January of that year, and the news drilled Scios¿ stock, devaluing it by 61 percent. Bayer AG, of Leverkusen, Germany, then stepped away, returning complete Natrecor rights to Scios. But the company regrouped, gathered new data and submitted an amended NDA in January. (See BioWorld Today, April 29, 1999; June 11, 1999; and Nov. 16, 2000.)
Since then, Scios, of Sunnyvale, Calif., has been gearing up for a Natrecor launch. It chose Quintiles Transnational Corp., of Research Triangle Park, N.C., in January to handle Natrecor sales. Scios recently completed a $114 million public offering of 5.75 million shares at $21 per share. (See BioWorld Today, May 31, 2001.)
If approved, the company said, Natrecor will become the first new treatment for acutely decompensated cardiovascular heart failure in more than a decade. Natrecor is a recombinant form of B-type natriuretic peptide.
Scios¿ stock (NASDAQ:SCIO) closed Tuesday at $21.29, down 56 cents, before the news broke.