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Biotech / Medical : SCIO Scios Inc. -- Ignore unavailable to you. Want to Upgrade?

To: ubrx who wrote (1385)	7/10/2001 5:44:25 PM
From: tuck	Read Replies (1) \| Respond to of 1477

>>SUNNYVALE, Calif., July 10 /PRNewswire/ -- Scios Inc. (Nasdaq: SCIO - news) announced today that it has received a letter from the U.S. Food and Drug Administration (FDA) stating that the Natrecor® (nesiritide) New Drug Application (NDA) is approvable. Scios has developed Natrecor as an intravenous treatment for patients with acutely decompensated congestive heart failure (CHF). The approvable letter is the official communication from the FDA that the agency is prepared to approve the NDA following 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 for the treatment of acute CHF on May 25, 2001. ``We are delighted to receive the approvable letter and are working closely with FDA to complete the final steps to approval,'' said Richard B. Brewer, Scios' president and chief executive officer. When approved by the FDA, Natrecor will become the first new treatment for acutely decompensated CHF in more than a decade. Natrecor is a recombinant form of B-type natriuretic peptide (BNP), and would become the first natriuretic peptide product available as a therapeutic in the United States. Human BNP is a naturally occurring hormone in the body that aids healthy functioning of the heart. Roughly five million Americans suffer from heart failure, with 550,000 new cases diagnosed each year. There are approximately one million hospitalizations each year in the United States due to acute CHF. Conference Call Scios executives will host a conference call and live audio webcast at 2:30 p.m. PDT (5:30 p.m. EDT) on Tuesday, July 10 to discuss Natrecor and its next steps to commercialization. To participate, please call 800-474-8920 at least 5 minutes prior to start time. To access the live webcast, please log on to www.sciosinc.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. A replay of the live webcast will be made available on the Scios website shortly after the conclusion of the call through July 18, 2001. A replay of the telephonic conference call will be available by dialing 888-203-1112, access code 713213. The telephone replay will be available through July 18, 2001.<< snip Cheers, Tuck