Novartis says Sandostatin successor clears phase III

A phase III trial of Novartis' somatostatin analogue pasireotide has found that the drug was more effective than the current standard therapy in controlling the signs and symptoms of acromegaly, a rare endocrine disorder.

Acromegaly is usually caused by a benign tumour on the pituitary gland, causing overproduction of growth hormone (GH) which in turn boosts other hormones - notably insulin-like growth factor (IGF-1) and can result in disfigurement and premature death if untreated.

Most patients can be effectively treated using the older somatostatin analogue octreotide, but "inadequate control of GH and IGF-1 remains an issue for many patients", according to the lead investigator in the Novartis-sponsored study, Annamaria Colao of the Federico II University of Naples in Italy.

In the trial, approximately 31 per cent of patients treated with pasireotide achieved full control of GH and IGF-1 levels, compared to 19 per cent of those treated with Novartis subsidiary Sandoz' Sandostatin LAR brand of octreotide.

In addition, patients treated with pasireotide were 63 per cent more likely to achieve control of their disease than those on Sandostatin, and the safety profile of the two drugs was similar with the exception of a higher degree of hyperglycaemia in patients treated with pasireotide.

Pasireotide is already marketed in the EU under the Signifor brand name for the treatment of adult patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed, becoming the first medicine for this disease to be approved in Europe.

Approval in acromegaly would take Novartis a step closer to positioning pasireotide as a successor to Sandostatin, which remains a big seller for the company with worldwide sales rising 12 per cent to reach $1.2bn last year.

While patents on Sandostatin LAR expired in July 2010 in most world markets, the drug still has protection from generic competition in the US until 2014. Novartis is expected to file for approval of pasireotide in acromegaly later this year.