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Data in NEJM shows Novartis drug Signifor® is first therapy to provide rapid, durable benefit for Cushing's disease patients in Phase III study
Date:3/7/2012

EAST HANOVER, N.J., March 7, 2012 /PRNewswire/ -- A study published in The New England Journal of Medicine (NEJM) found that the investigational drug Signifor® (SOM230, pasireotide), normalized cortisol levels and showed clinical benefit in patients with Cushing's disease(1). This study, which was first presented at the 14th Congress of the European Neuroendocrine Association in September 2010, is the first Phase III trial to demonstrate the efficacy of a medical therapy for Cushing's disease.

Cushing's disease is a debilitating endocrine disorder caused by excess cortisol in the body due to the presence of a non-cancerous pituitary tumor. There are currently no approved medicines that target Cushing's disease(5).

In the study, patients were randomized to receive pasireotide subcutaneous (sc) injection in doses of 900 micrograms or 600 micrograms twice daily. For the 900 microgram group, the study met the primary endpoint of normalizing urinary-free cortisol (UFC) levels, the key measure of biochemical control of the disease. UFC levels were normalized in 26.3% and 14.6% of patients with Cushing's disease randomized to receive pasireotide 900 micrograms and 600 micrograms twice daily, respectively, at six months of treatment. After 12 months of treatment, results confirmed the durability of the effect(1).

"While rare, Cushing's disease is a serious disease with no cure and very limited treatment options," said Annamaria Colao, MD, lead study investigator and Professor of Endocrinology, Chief of the Neuroendocrine Unit at the Department of Molecular and Clinical Endocrinology and Oncology, Federico II University of Naples. "These data on pasireotide are the first to show a therapeutic treatment can help patients achieve biochemical control of their Cushing's disease, while improving associated symptoms."

Study results also showed that cortisol levels decreased quickly in the majority of patients, with a median decreas
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SOURCE Novartis Pharmaceuticals Corporation
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