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FDA Advisory Committee Recommends Approval of Natrecor(R) for the Short-Term Management of Congestive Heart Failure
Scios' Genetically Engineered Product Could Become First New Medicine for This Use in a Decade
MOUNTAIN VIEW, Calif., Jan. 29 /PRNewswire/ -- Scios Inc. (Nasdaq: SCIO - news) announced today that the Cardiovascular and Renal Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) recommended approval of Natrecor® (nesiritide) for the short-term management of congestive heart failure (CHF). If approved by the FDA, it will be the first new short-term treatment for CHF in 10 years. Natrecor, developed by Scios, is the genetically engineered form of the naturally occurring cardiac human hormone, b-type natriuretic peptide (hBNP), which is secreted as part of the body's natural response to a failing heart.
''Today's advisory committee recommendation brings Natrecor one step closer to approval and to helping physicians manage the hospital treatment of their CHF patients,'' said Richard B. Brewer, President and CEO of Scios Inc. ''Scios is proud to have discovered and developed this genetically engineered cardiac hormone which is unlike any product currently available for acute episodes of congestive heart failure.'' Brewer also expressed confidence in the alliance with Bayer AG, which makes Bayer responsible for the commercial launch and marketing of Natrecor once the product receives FDA approval. ''Bayer has a powerful presence in the worldwide cardiovascular marketplace. Once Natrecor is approved, we are confident that Bayer will put the resources needed to bring it to physicians and health care professionals in the U.S. and, ultimately, throughout the world.''
Based on the successful outcome of clinical trials involving more than 500 patients, Scios submitted a New Drug Application (NDA) for Natrecor to the FDA in April 1998, just over four years after beginning the clinical trials. Although the FDA is not bound by the decisions of the advisory committee, the agency typically follows its advisory committees' advice.
''We worked cooperatively with the FDA over a four-year period to develop a program to show Natrecor has a favorable effect on key measures of cardiac performance and makes patients feel better, while characterizing the safety profile of the product,'' said Elliott B. Grossbard, M.D., Senior Vice President of Development of Scios Inc. ''We are very pleased with the outcome of that collaboration.''
Clinical Trial Results
The key pivotal Phase III efficacy study was a multi-center, randomized, placebo-controlled, double-blind clinical trial. The clinical studies focused on measurements of two key hemodynamic markers. The study outcomes included:
* A decrease in pulmonary capillary wedge pressure (PCWP), a measure of the blood pressure in the heart that when elevated, forces fluid into the lungs causing respiratory problems (the primary endpoint).
* An increase in cardiac index, a measure of how much blood the heart is putting into circulation for the body's organs (secondary endpoint).
A dose-related decrease in blood pressure was the most commonly observed side effect in the clinical trials.
Congestive Heart Failure (CHF)
A potentially life-threatening disorder that has no cure, congestive heart failure (CHF) is a chronic pathophysiologic condition in which the heart functions inefficiently and circulation is reduced to the body's organs. As a result, fluid accumulates in the tissues, including lung tissue, causing such symptoms 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.
During an acute episode of CHF, the heart's inability to adequately circulate blood throughout the body worsens beyond its already compromised state, causing symptoms to become so pronounced that hospital treatment is required to stabilize the patient's condition. A sudden increase in dietary sodium (salt), failure to take medications for managing CHF, or the development of a new heart arrhythmia can precipitate an acute attack.
Roughly five million Americans suffer from CHF, however, only half are diagnosed with the condition, which may go undetected because the body often compensates for many of the symptoms. There are approximately one million hospitalizations in the U.S. each year with CHF as the primary diagnosis. Another two million Americans are hospitalized each year with CHF as the secondary diagnosis. In the U.S., CHF accounts for the largest cause of hospitalizations for patients over age 65. 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 approved for its proposed indication, Natrecor would provide a new option for treating these patients.
The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties, and may include references to the approval of Natrecor, as well as the other risks detailed from time to time in the Company's SEC reports, including its annual report on Form 10-K for the year ended December 31, 1997 and subsequent reports on Form 10-Q.
Scios-Bayer Alliance
Under the terms of a strategic alliance announced in May 1998, Scios will supply Natrecor to Bayer AG for commercial launch and ongoing marketing by Bayer. The alliance was forged based on Bayer's demonstrated strength cardiovascular experience and the fit of Natrecor with Bayer's CV business. Approximately 40 percent of Bayer's business stems from the CV market, and the company has a significant presence in hospitals as well as among office-based physicians. Bayer is the fifth largest CV presence worldwide among all pharmaceutical companies.
Scios Inc.
Scios is a biopharmaceutical company engaged in the discovery, development, manufacture and commercialization of novel human therapeutics. Apart from its research pipeline efforts, Scios has two major clinical development programs. Natrecor® (nesiritide), the featured topic of this press release, is awaiting approval by the FDA for the short-term treatment of acute congestive heart failure. Fiblast® (trafermin) is in Phase II/III clinical trials in Europe for the treatment of stroke and additional Phase II clinical trials in vascular disease are planned. In addition to its collaboration with Bayer AG, Scios has research and development collaborations with Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products Corporation [NYSE:AHP - news], Kaken Pharmaceutical Co., Ltd., Eli Lilly and Company [NYSE:LLY - news], The DuPont Pharmaceuticals Company and Novo Nordisk A/S [NYSE:NVO - news] of Denmark. Scios' commercial operations division successfully markets six psychiatric products. Additional information on Scios is available at its web site located at sciosinc.com and in the Company's various filings with the Securities and Exchange Commission.
Bayer Group
Bayer AG is an international, research-based group with major businesses in health care, chemicals and imaging technologies. With more than 144,000 employees worldwide, the group recorded income before taxes of DM 5.1 billion on sales of DM 55 billion in 1997. For the current year, DM 5 billion is earmarked for capital expenditures. A record DM 4.1 billion is budgeted for research and development, attesting to the company's drive for innovation.
Bayer Corporation is a research-based company with major businesses in health care and life sciences, chemicals and imaging technologies. The company had 1997 sales of $9.3 billion and employs 24,000 people. Bayer Corporation is investing approximately $9 billion in capital expenditures and research and development in its U.S. operations from 1995 through the year 2000. Capital expenditures for 1997 totaled $746 million, and $639 million was spent for R&D. Bayer Corporation, with headquarters in Pittsburgh, is a member of the worldwide Bayer Group, a $32 billion chemical and pharmaceutical company based in Leverkusen, Germany |
