An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease (Seascape)

Inclusion Criteria

Inclusion criteria:

1. Patients with confirmed diagnosis of Cushing's disease as evidenced by

- mean urinary free cortisol of three 24-hour urine samples collected during the
2-week screening period above the upper limit of the laboratory normal range

- morning plasma adrenocorticotropic hormone (ACTH) within the normal or above
normal range

- either Magnetic Resonance Imaging (MRI) confirmation of pituitary adenoma
(greater than or equal to 0.6 cm), or inferior petrosal sinus gradient >3 after
corticotrophin-releasing hormone (CRH) stimulation for those patients with a
microadenoma less than 0.6 cm, or for patients who have had prior pituitary
surgery, histopathology confirming an ACTH staining adenoma.

2. Patients with de novo Cushing's disease must not be considered as candidates for
pituitary surgery (i.e. poor surgical candidates, surgically unapproachable tumors,
patients with no visible pituitary tumor, patients who refuse to have surgical
treatment)

3. Karnofsky performance status >60 (i.e. requires occasional assistance, but is able to
care for most of his personal needs)

Exclusion criteria:

1. Radiotherapy of the pituitary <4 weeks before screening or patient who has not
recovered from side effects

2. Patients with compression of the optic chiasm causing acute clinically significant
visual field defect

3. Patients with Cushing's syndrome due to ectopic ACTH secretion

4. Patients with hypercortisolism secondary to adrenal tumors or nodular (primary)
bilateral adrenal hyperplasia

5. Patients who have undergone major surgery within 1 month prior to screening

6. Patients with symptomatic cholelithiasis

7. Patients who have clinically significant impairment in cardiovascular function or are
at risk thereof.

Other protocol-defined inclusion/exclusion criteria may apply