NVS Presents Positive Data at ASH - Analyst Blog

Recently, Novartis AG (NVS) presented data from a phase II study of its blood cancer pipeline drug LBH589 at the annual meeting of the American Society of Hematology (ASH).

The phase II pivotal study showed sustained anticancer activity in extensively pretreated Hodgkin lymphoma patients who had relapsed or had become refractory after an autologous stem cell transplant. There is a high, unmet treatment need in this setting.

Many of the 106 patients enrolled in the study had received multiple courses of chemotherapy. As many as 82% of the patients in the study achieved stable disease while 74% achieved tumor reduction at a median follow-up of 9.6 months.

The primary endpoint of complete response to treatment was seen in 27% of the group with a median duration of response of 6.9 months and a median progression-free survival measured at 10.5 months.

Novartis intends to file for approval of the candidate based on the study results.

Hodgkin lymphoma is a cancer that originates from white blood cells, or lymphocytes and affects people in the ages of 15 and 35 and in adults over 50.

The company is also studying LBH589 in multiple myeloma (phase III), acute myeloid leukemia (early stage) and myelodysplastic syndromes (early stage).

The company, at the same meeting, presented 24-month data from a phase III trial, which showed that its drug Tasigna continues to be superior to Glivec, another Novartis drug, in slowing disease progression in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

Our Recommendation

Currently, we have a Neutral recommendation on Novartis, which is supported by a Zacks #3 Rank. We are pleased with Novartis' wide range of products and its efforts to diversify further as is evident by the recent acquisition of a majority stake in Alcon. The company is looking to acquire the remaining stake in the eye-care company. However, we prefer to remain on sidelines due to the upcoming patent cliff for the company as a number of Novartis drugs will face generic competition between 2011 and 2015.