Positive Data on Novartis Drug – Analyst Blog

Novartis AG (NVS) recently announced positive data from a late-stage trial of SOM230 (pasireotide) being studied for the treatment of Cushing’s disease. The study (PASPORT-CUSHINGS) was conducted to evaluate the safety and efficacy of SOM230 in 62 patients with recurrent Cushing’s disease, and in patients with newly diagnosed Cushing’s disease who have not undergone surgery.

 

The trial data demonstrated that after six months of treatment with SOM230, patients experienced lower urinary free cortisol (UFC) levels, a measure of disease control. Roughly 26% of the patients reported normal UFC levels after taking 900 ug dose of the drug twice daily for six months. Novartis also said that the effect of the drug continued even after 12 months of treatment.

 

The candidate, SOM230, has orphan drug status in the US and Europe. This status is designated for drugs that treat rare diseases affecting a sparse patient population for which adequate treatment is not available. Cushing’s disease affects annually about 10 to 15 people per million. This disease is caused by a benign tumor in the pituitary gland and its symptoms are weight gain, central obesity, moon face, severe fatigue and weakness, striae (purple stretch marks), depression and anxiety. Untreated Cushing’s disease can also lead to death due to cardiovascular complications.

 

Currently, there is no drug in the market to treat Cushing’s disease. The only option available is the removal of the tumor through surgery or radiotherapy.

 

We currently have a Neutral recommendation on Novartis, which is supported by a Zacks #3 Rank (short-term Hold rating). We are pleased with the study results of SOM230 as the approval of the drug will allow Novartis to get a strong foothold in the Cushing’s disease market. Novartis plans to file for regulatory approval of the drug by the end of 2010.