Contact: Geoff Cook
Novartis Pharmaceuticals Corp.
973/781-5486
NOVARTIS THERAPY TO PREVENT ACUTE REJECTION IN RENAL TRANSPLANTS CLEARED FOR MARKETING
-- In Two Simple Doses, Simulect" Reduces Acute Renal Rejection Episodes By One-Third --
EAST HANOVER, NJ, May 13, 1998 -- Novartis Pharmaceuticals Corporation announced today that the U.S. Food and Drug Administration (FDA) granted marketing clearance for Simulect" (basiliximab) for prevention of acute rejection episodes in renal transplant recipients. Simulect is a two-dose, high-affinity, monoclonal antibody. Results of clinical trials in the U.S., Canada and Europe being presented today at the joint annual meetings of the American Societies for Transplant Physicians and Surgeons (ASTP/ASTS) demonstrate that Simulect reduces the rate of acute rejection episodes by one-third.
"Simulect benefits patients by significantly reducing acute rejection episodes with minimal side effects in the critical four to six weeks following renal transplantation," said Michael Hall, M.D., director, clinical research, transplant/immunology at Novartis Pharmaceuticals Corporation. "It offers a convenient, two-dose regimen that allows patients to complete antibody induction therapy before leaving the hospital. This helps to ensure full treatment compliance and a timely hospital discharge."
Acute rejection is an aggressive immune response mounted against the transplanted organ that most frequently occurs during the first six weeks following transplant. If left untreated, this response can lead to loss of the organ. Despite currently effective anti-rejection therapies, a significant proportion of organ transplant recipients still experience acute rejection episodes which may require aggressive treatment and/or hospitalization to prevent organ loss.
Simulect is an immunosuppressant that works by blocking the receptor for interleukin-2, a protein that stimulates the proliferation of certain white blood cells, T-lymphocytes. These white blood cells play a key role in transplant organ rejection. The mechanism of action of Simulect complements that of cyclosporine, the most widely prescribed primary immunosuppressant therapy for the prevention of organ rejection.
Phase III clinical trials (n=729) showed a two-dose regimen of Simulect (20 mg per dose of Simulect on day zero and day four), used concomitantly with cyclosporine for microemulsion and corticosteroids, proportionately reduced the incidence of biopsy-proven acute rejection by nearly one-third (31% incidence with Simulect; 45% with placebo, p<.001) during the first six months post transplant. This effect was maintained for at least 12 months. The clinical benefit of Simulect was observed in a broad range of transplant patients (living donor and cadaveric) as well as in known high-risk patient groups.
Simulect is well tolerated. Both the acute tolerability and the 12-month adverse event profiles were comparable in the Simulect and placebo treatment groups. Study results found that in the Simulect patient groups, there were no reports of cytokine release syndrome (a potentially life-threatening reaction with "flu-like" symptoms). Simulect also was not found to cause myelosuppresion or lowering of the blood cell count. The rates for malignancies, reported infections and serious infections were similar in the Simulect and placebo treatment groups.
While the incidence of lymphoproliferative disorders and opportunistic infection in the controlled clinical trials was no higher in Simulect-treated patients than in patients treated with placebo, patients on immunosuppressive therapy are at increased risk for developing lymphoproliferative disorders and opportunistic infections and should be monitored accordingly.
Simulect has been designated as an orphan drug by The Office of Orphan Products Development, the arm of the FDA dedicated to promoting the development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. Since 1983, the OOPD has cleared over 130 drugs and biological products for rare diseases for market.
Only physicians experienced in immunosuppressive therapy with organ transplantation patients should prescribe Simulect. Physicians responsible for Simulect administration should have complete information requisite to the follow-up of the patient. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources.
It is not known whether Simulect use will have a long-term effect on the ability of the immune system to respond to antigens first encountered during Simulect-induced immunosuppression.
Novartis Pharmaceuticals Corporation researches, develops and markets leading innovative prescription drugs used to treat a number of diseases and conditions including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, cancer and arthritis. The company's mission is to improve people's lives by pioneering novel healthcare solutions.
Novartis is a world leader in Life Sciences with core business in Healthcare, Agribusiness and Nutrition. In 1997, Novartis Group sales were 31.2 billion Swiss francs ($21.6 billion), of which 18.8 billion ($13.0 billion) were in Healthcare, 8.3 billion ($5.8 billion) in Agribusiness and 4.1 billion ($2.8 billion) in Nutrition. The group annually invests more than 3.6 billion Swiss francs ($2.5 billion) in R&D. Headquartered in Basel, Switzerland, Novartis employs about 87,000 people and operates in over 100 countries around the world.
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For a copy of the full prescribing information for Simulect" and Neoral", please call Geoff Cook at 973/781-5486.
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