Scios Announces Recommended Use Initiative for NATRECOR(R)

FREMONT, Calif., Aug. 22 /PRNewswire/ — Scios Inc. today announced it is launching a comprehensive recommended use initiative for NATRECOR(R) (nesiritide), its treatment for acutely decompensated heart failure (ADHF). The intent of the initiative is to educate healthcare providers regarding those patients who should receive NATRECOR(R) and those for whom Scios does not recommend the use of NATRECOR(R) based on currently available clinical data.

The recommended use initiative is a direct response to recommendations the company recently sought from a panel of leading U.S. cardiologists. The full panel report can be found at http://www.natrecor.com/. All company activities related to NATRECOR(R) will be focused on use in patients with ADHF presenting to the hospital with shortness of breath — or dyspnea — at rest or with minimal activity (such as talking, eating or bathing).

“We are committed to our recommended use initiative and we are confident that it will further assist healthcare professionals in identifying appropriate patients for treatment with NATRECOR(R),” said Darlene Horton, M.D., senior vice president of clinical research and medical affairs at Scios. “NATRECOR(R) continues to be an important therapy for patients presenting to the hospital with ADHF. These patients have few well-studied treatment options.”

The NATRECOR(R) recommended use initiative will be rolled out over the next several weeks and will consist of a number of activities, including:

    —   Training the entire sales force and all promotional speakers         regarding the recommended use of NATRECOR(R),    —   The creation of new promotional materials for use with healthcare         providers,    —   Including recommended use language in promotional speakers programs,         and    —   Advertising in top-tier medical journals.   

To date, the company has disseminated a letter to more than 160,000 healthcare professionals describing those patients for whom NATRECOR(R) therapy is appropriate, incorporated the recommended use information into the toll-free NATRECOR(R) support line and trained external speakers on the recommended use of NATRECOR(R).

In May of 2005, Scios asked Dr. Eugene Braunwald, Distinguished Hersey Professor of Medicine, Harvard Medical School, and Chairman TIMI Study Group at Brigham and Women’s Hospital in Boston, to identify and convene a panel of leading cardiologists to review and assess important data associated with NATRECOR(R), to provide guidance and counsel on the ongoing and planned clinical development program and to provide recommendations with regard to use of the product. The panel met on June 8th and, shortly thereafter, issued recommendations to the company that included an educational program related to the appropriate use of NATRECOR(R).

“We asked the panel to provide us with guidance regarding NATRECOR(R), and we have shared and discussed our planned response to these recommendations with panel members,” said Dr. Horton. “With regard to the use of NATRECOR(R), there are some modest differences between the panel’s specific recommendations and Scios’ recommended use initiative. However, we believe that this comprehensive effort enhances our focus on advocating the use of NATRECOR(R) in a patient population that is consistent with the population studied in the trials that led to the approval of the drug.”

NATRECOR(R) remains the only therapy approved for the treatment of ADHF that has a demonstrated clinical benefit, specifically the improvement of severe breathing difficulties leading to hospitalization. More information is known about NATRECOR(R) — based on large, well-controlled clinical trials — than exists for any other intravenous therapy approved for ADHF.

“We are committed to studying NATRECOR(R) to further demonstrate its value for these very sick patients,” added Dr. Horton. “Consistent with the panel’s recommendations, we are proceeding with our clinical development program through FUSION II and other studies to better understand how this medicine can benefit patients with this debilitating condition.”

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 http://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 hypotension may be increased with higher doses of NATRECOR(R) or in patients with baseline blood pressure <100 mm Hg, and NATRECOR(R) should be used cautiously in these patients.

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, at 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, at 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).

Scios Inc.

CONTACT: Mark T. Wolfe of Scios, +1-908-927-2745, or cell,+1-908-672-4988

Web site: http://www.sciosinc.com/