An Open-label, Multi-center, Expanded Treatment Protocol of Pasireotide LAR in Patients With Acromegaly

Inclusion Criteria:

- Patients with confirmed diagnosis of active acromegaly with elevated IGF-1 (>ULN) and
random GH (>1 μg/L) within 30 days of screening.

- Patients who are not controlled by pituitary surgery or who are not eligible for or
refuse surgery.

- For patients on medical treatment for acromegaly the following washout periods must
be completed before screening assessments are performed:

- Dopamine agonists (bromocriptine, cabergoline): 4 weeks

- GH-receptor antagonists (pegvisomant): 8 weeks

- Somatostatin analogues: no washout period required

- Karnofsky performance status ≥ 60.

Exclusion Criteria:

- Concomitant treatment with somatostatin analogues unless concomitant treatment was
discontinued 28 days before first pasireotide LAR injection is administrated.

- Concomitant treatment with growth hormone receptor (GHR)-antagonists or dopamine
agonists unless concomitant treatment was discontinued and the washout period was
completed before the screening assessments are performed.

- Patients with compression of the optic chiasm causing any visual field defect for
whom surgical intervention is indicated.

- Patients who require a surgical intervention for relief of any sign or symptom
associated with tumor compression.

- Patients who have undergone major surgery/surgical therapy for any cause within 4
weeks of screening.

- Patients who have received radiotherapy of the pituitary within 4 weeks prior to
screening or have not recovered from side effects of radiotherapy.

- Patients who have a history of hypothyroidism and who are not adequately treated with
stable doses of thyroid hormone replacement therapy.

- Patients with active malignant disease within the last five years (with the exception
of basal cell carcinoma or carcinoma in situ of the cervix).

- Diabetic patients whose blood glucose is poorly controlled.

Other protocol-defined inclusion/exclusion criteria may apply.