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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: Biomaven who wrote (6038)3/26/2002 4:53:23 PM
From: Biomaven  Read Replies (2) | Respond to of 52153
 
Some nice publicity today after the close for SCIO:

Tuesday March 26, 4:00 pm Eastern Time
Press Release
SOURCE: Scios Inc.
Scios Announces Publication in Journal of the American Medical Association Supporting First-Line Use of Natrecor to Treat Acute Heart Failure
SUNNYVALE, Calif., March 26 /PRNewswire-FirstCall/ -- Scios, Inc. (Nasdaq: SCIO - news) today announced that the lead article and editorial published in this week's issue of the Journal of the American Medical Association (JAMA) support the use of the company's flagship product, Natrecor® (nesiritide), for the treatment of acutely decompensated congestive heart failure in patients with shortness of breath at rest or with minimal activity.

``This publication reinforces our belief that Natrecor is an ideal initial agent for physicians to use along with diuretics before considering conventional treatment options,'' said Darlene P. Horton, M.D., Vice President of Medical Affairs at Scios. ``The clinical community has indicated they are enthusiastic about using Natrecor as part of a new treatment paradigm for acute heart failure.''

The lead article reported the results of the VMAC (Vasodilation in the Management of Acute Congestive Heart Failure) study, a randomized double-blind trial involving 489 patients with acute heart failure treated at 55 hospitals between October 1999 and July 2000. These patients were assigned to one of four treatment groups. They received either a fixed or adjustable dose of intravenous Natrecor, intravenous nitroglycerin or placebo plus standard care.

The investigators tracked changes in dyspnea, or shortness of breath, and pulmonary capillary wedge pressure (PCWP). PCWP estimates the heart's internal filling pressure and is a standard measure of cardiac function in patients with acute heart failure.

The improvement (reduction) in PCWP was significantly greater in the Natrecor group than in the nitroglycerin or placebo groups, starting with the first measurement at 15 minutes. Sixty percent of the three-hour reduction in PCWP was observed at 15 minutes and 95 percent of the three-hour reduction in PCWP was seen in the first hour. At three hours, the effect of Natrecor on PCWP was statistically significantly greater than both nitroglycerin and placebo while the effect of nitroglycerin was similar to placebo. At 24 hours the mean reduction in PCWP was significantly greater with Natrecor than nitroglycerin (placebo patients had crossed over to active therapy after three hours).

Patients who received Natrecor also reported feeling less breathless at three hours compared to placebo plus standard care whereas the effect of nitroglycerin was similar to placebo. There were no significant differences in the frequency of serious adverse events through 30 days for either treatment group.

``The findings reported in this publication suggest that Natrecor should be used as a first-line treatment for acutely decompensated CHF,'' said lead author James B. Young, M.D., medical director of the Kaufman Center for Heart Failure at The Cleveland Clinic and head of the Section of Heart Failure at The Cleveland Clinic Heart Center.


The related JAMA editorial was basically positive but much more cautious than that "first-line" quote might indicate.

The full text is available at the JAMA site:

Intravenous Nesiritide vs Nitroglycerin for Treatment of Decompensated Congestive Heart Failure

jama.ama-assn.org

Treatment of Acute Heart Failure
Out With the Old, In With the New


jama.ama-assn.org

See also the report of the failure of Milrinone, a dobutamine-like drug:

Short-term Intravenous Milrinone for Acute Exacerbation of Chronic Heart Failure
jama.ama-assn.org

Peter



To: Biomaven who wrote (6038)3/26/2002 5:27:22 PM
From: rkrw  Read Replies (1) | Respond to of 52153
 
<<Last year there was a fuss with some biotech company's product when the IMS data was flat-out wrong for a month or so. Produced some big swings in the stock price while it got sorted out. (Anyone recall the drug involved?)>>

Thalomid?