Another Natrecor milestone met...
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Monday July 31, 10:00 am Eastern Time
Company Press Release
SOURCE: Scios Inc.
Scios Completes Patient Enrollment in Pivotal Phase
III Natrecor Trial
Initial Analysis of VMAC Data to Be Presented This Fall; Company to File NDA Amendment by End of Year
SUNNYVALE, Calif., July 31 /PRNewswire/ -- Scios Inc. (Nasdaq: SCIO - news) today announced that enrollment has been completed in its Phase III clinical trial investigating Natrecor® (nesiritide) for the treatment of acute congestive heart failure (CHF).
Known as the VMAC (Vasodilation in the Management of Acute Congestive heart failure) trial, this 480-patient trial is designed to further evaluate the efficacy and safety of Natrecor in acutely ill patients with shortness of breath (dyspnea) at rest due to decompensated CHF and is the final pivotal trial to support FDA approval of Natrecor. The Company expects to announce its initial analysis of results in the Fall and submit an amendment to its New Drug application (NDA) for Natrecor to the FDA by the end of 2000.
``Thanks to the dedicated efforts and commitment of our clinical investigators, we completed this trial within just nine months and ahead of schedule,'' said Darlene P. Horton, M.D., Senior Director of Clinical Research for Scios. ``This is a major achievement for everyone at Scios who worked so diligently on this priority development project. We will now expedite analysis and reporting of these important data, which we believe will lead to the first new drug for the treatment of acute CHF in more than a decade.''
Natrecor is Scios' recombinant form of B-type natriuretic peptide (BNP), a hormone secreted by the heart in response to heart failure. In clinical studies to date, the results of which were published in this week's issue of The New England Journal of Medicine, intravenous Natrecor administration has significantly improved typical CHF symptoms, such as severe shortness of breath and fatigue. Natrecor was also shown to improve cardiac hemodynamics, decreasing pulmonary capillary wedge pressure, systemic vascular resistance, and right atrial pressure, and increasing cardiac index.
``This drug has excellent potential,'' said James B. Young, M.D., chairman of the VMAC study and Head, Section of Heart
Failure and Cardiac Transplant Medicine at the Cleveland Clinic Foundation. ``It's safe, well-tolerated, and has physiologic effects that are quite different from the other drugs that are available for acute decompensated heart failure, and may in fact be safer. We look forward to analyzing these results, which could bear these facts out further.''
``Scios now leads the way toward introducing a new agent to treat acute CHF,'' said Richard B. Brewer, Scios' President and Chief Executive Officer. ``We are the only company with a completed Phase III pivotal trial evaluating a new treatment for this important disease.''
A potentially life-threatening disorder that has no cure, heart failure is a chronic pathophysiologic condition in which the heart functions inefficiently and circulation is reduced to the body's organs. In congestive heart failure, fluid accumulates in the tissues, including lung tissue, causing symptoms such as difficulty breathing, swelling of the hands and feet, difficulty sleeping, dry cough, fatigue and/or rapid weight gain. CHF may result from an acute event (e.g., heart attack) or may develop gradually over time.
Roughly five million Americans suffer from heart failure, however, only half are diagnosed with the condition, which may go undetected because the body often compensates for many of the symptoms. As the population ages and treatments advance for some of the causes of CHF (such as myocardial infarction and hypertension), the number of patients diagnosed with CHF is growing. Despite this, no new treatments for CHF have been developed in more than 10 years.
According to the National Center of Health Statistics, CHF ranks among the leading causes of hospital admissions in the United States, resulting in approximately one million admissions annually. Another two million Americans are hospitalized each year with CHF as the secondary diagnosis. Virtually all CHF patients will have at least one acute episode, where the symptoms are so severe that often only intravenous (IV) medications administered in the hospital can improve patients' health.
If you are a physician and would like medical information on Natrecor, call 800-972-4670.
Scios Inc.
Scios is a biopharmaceutical company engaged in the discovery, development, and commercialization of novel human
therapeutics. Scios has commercial or research and development relationships with Chiron Corporation, DuPont Pharmaceuticals Company; Eli Lilly and Company; GenVec, Inc.; Kaken Pharmaceutical Co., Ltd.; and Novo Nordisk A/S, of Denmark.
Additional information on Scios is available at its web site located at www.sciosinc.com and in the company's various filings with the Securities and Exchange Commission.
The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. These include the risks concerning the success of the VMAC trial and regulatory approval of Natrecor, as well as other risks detailed from time to time in the reports filed by Scios with the SEC, including the company's annual report on form 10-K for the year ended December 31, 1999 and subsequent reports on form 10-Q.
SOURCE: Scios Inc. |
