FREMONT, Calif., June 1 /PRNewswire/ -- Scios Inc. today announced an international outcomes study involving as many as 7,000 patients designed to further assess the benefits and safety profile of NATRECOR(R) in patients with acutely decompensated heart failure. The company plans to make a significant investment to conduct the trial, which is one component of a comprehensive clinical development plan for NATRECOR(R). When completed, the outcomes study will be the largest and most comprehensive study of its kind, helping to advance knowledge about a large and critically ill patient population.
“With this landmark trial, we are fulfilling our commitment to do a large outcomes study following the recommendations of an expert panel,” said Roger Mills, M.D., Vice President, Medical Affairs at Scios. “This trial underscores our confidence in the safety and efficacy of NATRECOR(R) as a treatment for acutely decompensated heart failure and reflects a major commitment to heart failure patients and the doctors, nurses and pharmacists who help treat these patients. “We believe this study will deliver timely, thorough and meaningful data regarding the safety and efficacy of NATRECOR(R), and more clearly define the benefit/risk ratio.”
In June 2005, Scios brought together an expert panel of cardiology and heart failure clinicians to provide recommendations regarding NATRECOR(R). Chaired by Eugene Braunwald, M.D., Distinguished Hersey Professor of Medicine at Harvard Medical School and Chairman of the TIMI Study Group at Brigham and Women’s Hospital in Boston, the panel assessed important data associated with NATRECOR(R) and provided guidance and counsel on the ongoing and planned clinical development program for the product, as well as offering recommendations for use. The panel endorsed Scios’ plan to conduct several trials, including a large trial of clinical outcomes. In the period since the expert panel provided its recommendations, Scios has been actively exploring a broad range of trial design options that would meet the goals identified by the panel, as well as other critical goals to further advance knowledge of heart failure.
“I am pleased that Scios is following through on the panel recommendations with such an ambitious trial that will help us learn more about the optimal treatment of acute heart failure, a large unmet medical need that is not adequately served,” said Dr. Braunwald.
Heart failure affects nearly 5 million Americans and is the most frequent cause of hospitalization in patients over 65 years of age. With 550,000 new cases each year, the number of new heart failure cases exceeds those of AIDS, breast cancer or Alzheimer’s disease. Acute heart failure results in nearly 1 million hospitalizations annually -- more than the number of patients hospitalized for heart attack -- and is responsible for more annual deaths than leukemia, breast, pancreatic and ovarian cancers.
NATRECOR(R) with standard therapy is the only approved treatment for acutely decompensated heart failure that has demonstrated in controlled clinical trials the clinical benefit of improvement of dyspnea and reduction of filling pressure. NATRECOR(R) has been widely studied in a comprehensive clinical program. To date, it has been studied in 1,529 patients in 14 clinical trials, and additional clinical trials are under way or planned that will collect further data related to mortality and the renal impact of NATRECOR(R).
Study Details
The trial will be conducted at centers in the United States, Canada and Europe and involve as many as 7,000 patients with acutely decompensated heart failure. It will evaluate improvement in dyspnea (shortness of breath), rehospitalization, mortality, renal effects, quality of life and pharmacoeconomics.
Patient enrollment is expected to begin in the first quarter of 2007. In the coming months, Scios will finalize and announce the independent academic research organization that will oversee and execute the trial, including a study chair, principal investigators, DSMB and steering committee. In addition, the company will hold discussions with regulatory authorities about the proposed clinical development plan.
“Acutely decompensated heart failure patients are typically critically ill and often have co-morbidities. Consequently, many considerations were taken into account, including gathering diverse input from heart failure thoughtleaders, reviewing recently conducted clinical trials and assessing guidance from a broad range of regulatory authorities,” added Dr. Mills. “This led to our decision to embark upon what will be a landmark trial in the field of acutely decompensated heart failure. Patient safety is our priority, and we are confident that data generated from this study will advance our understanding of the treatment of patients with acutely decompensated heart failure.”
About NATRECOR(R) (nesiritide)
NATRECOR(R) is indicated for the intravenous treatment of patients with acutely decompensated congestive heart failure who have dyspnea at rest or with minimal activity. In this population, the use of NATRECOR(R) reduced pulmonary capillary wedge pressure and improved dyspnea. For full Prescribing Information, visit www.natrecor.com.
About Scios Inc.
Scios Inc., a Johnson & Johnson company, is a biopharmaceutical company headquartered in Fremont, California. Scios is developing novel treatments for cardiovascular disease, inflammatory disease and cancer. The company’s disease-based technology platform integrates expertise in protein biology with computational and medicinal chemistry to identify novel targets and rationally design small molecule compounds and peptides for markets with unmet medical needs. For more information, visit www.sciosinc.com.
IMPORTANT SAFETY INFORMATION
HYPOTENSION
NATRECOR(R) (nesiritide) may cause hypotension and should be administered only in settings where blood pressure can be monitored closely. If hypotension occurs during administration of NATRECOR(R) the dose should be reduced or discontinued. At the recommended dose of NATRECOR(R), the incidence of symptomatic hypotension (4%) was similar to that of IV nitroglycerin (5%). Asymptomatic hypotension occurred in 8% of patients treated with either drug. In some cases, hypotension that occurs with NATRECOR(R) may be prolonged. The mean duration of symptomatic hypotension was longer with NATRECOR(R) than IV nitroglycerin (2.2 versus 0.7 hours, respectively). NATRECOR(R) should not be used in patients with systolic blood pressure <90 mm Hg or as primary therapy in patients with cardiogenic shock. The rate of symptomatic hypotension may be increased with a baseline blood pressure <100 mm Hg, and NATRECOR(R) should be used cautiously in these patients. In earlier trials, when NATRECOR(R) was initiated at doses higher than the 2 mcg/kg bolus followed by a 0.01 mcg/kg/min infusion, the frequency, duration, and intensity of hypotension was increased. The hypotensive episodes were also more often symptomatic and/or more likely to require medical intervention. NATRECOR(R) is not recommended for patients for whom vasodilating agents are not appropriate and should be avoided in patients with low cardiac filling pressures.
RENAL
NATRECOR(R) may affect renal function in susceptible individuals. In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with NATRECOR(R) may be associated with azotemia. In the VMAC trial, through day 30, the incidence of elevations in creatinine to >0.5 mg/dL above baseline was 28% and 21% in the NATRECOR(R) and nitroglycerin groups, respectively. When NATRECOR(R) was initiated at doses higher than 0.01 mcg/kg/min, there was an increased rate of elevated serum creatinine over baseline compared with standard therapies, although the rate of acute renal failure and need for dialysis was not increased.
MORTALITY
In seven NATRECOR(R) clinical trials, through 30 days, 5.3% in the NATRECOR(R) treatment group died as compared with 4.3% in the group treated with other standard medications. In four clinical trials, through 180 days, 21.7% in the NATRECOR(R) treatment group died as compared with 21.5% in the group treated with other medications. There is not enough information to know if there is an increased risk of death after treatment with NATRECOR(R).
See full Prescribing Information at www.natrecor.com.
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Johnson & Johnson ‘s expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson ‘s Annual Report on Form 10-K for the fiscal year ended January 1, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov or on request from the Johnson & Johnson. Johnson & Johnson assumes no obligation to update any forward-looking statements as a result of new information or future events or developments.
Scios Inc.
CONTACT: Chris Ernst of Scios Inc., +1-510-248-2819, or cell,+1-415-710-9445, or cernst1@scius.jnj.com
