Novartis passes Phase III test for rare-disorder drug

Novartis ($NVS) has met the main goal of a late-stage study of the company's experimental drug against a rare endocrine disorder. The Swiss drug giant says its experimental drug pasireotide LAR beat the standard of care in the largest Phase III study involving patients with acromegaly, which triggers overproduction of growth hormone and leads to enlarged feet, hands and organs.

Patients on pasireotide, code named SOM230, gained full control of their disease in 31.3% of cases compared with 19.2% of patients on the standard therapy, octreotide LAR, marketed as Sandostatin. Patients treated with Novartis' drug were also 63% more likely to gain full control than patients on Sandostatin, according to the company. Adverse events in the 358-patient study included hyperglycemia, diarrhea, nasopharyngitis and headaches. 

"The positive results seen in the Phase III trial point to the potential role of pasireotide LAR in treating patients with acromegaly, a condition for which there remains an unmet need," said Hervé Hoppenot, president of Novartis Oncology. "These findings are welcome news as we continue our research efforts to discover treatments for patients with pituitary-related conditions."

Novartis' results were presented at the 2012 joint 15th International Congress of Endocrinology and 14th European Congress of Endocrinology meeting in Florence, Italy.

- here's the release
- and Reuters' update

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