NVS Provides Tasigna Study Data

Swiss pharmaceutical giant Novartis (NVS - Snapshot Report) recently presented data from two phase III studies comparing Tasigna (nilotinib) with Glivec (imatinib) for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in newly diagnosed patients. The patients in the study were switched to Tasigna after long-term treatment with Glivec.

The company presented these data at the American Society of Hematology (ASH). Results from the two-year ENESTcmr study showed that patients who switched to Tasigna achieved a significant deeper molecular response compared to those who remained under Glivec treatment. The study also revealed that more than twice as many patients treated with Tasigna were persistent in achieving undetectable BCR-ABL compared to Glivec.

Novartis also presented data from a four-year landmark analysis from ENESTnd on Tasigna. Results from this study showed that more than thrice as many patients with Tasigna as frontline therapy achieved early molecular response compared to Glivec.

Novartis also presented efficacy and safety data from a separate four-year analysis from ENESTnd. The data showed that molecular response rates of both 4 and 4.5 were higher for Tasigna. Novartis also reported that overall survival remained same in all the groups at the end of four years, though a lesser number of deaths occurred in both the Tasigna dose (300mg and 400mg) compared to Glivec.

We note that Tasigna is already approved as a treatment of first and second line chronic myeloid leukemia (CML) and Ph+ CML in adults who are resistant or intolerant to Glivec. Novartis reported Tasigna sales of $261 million in the third quarter of 2012. In November, the company stated that it is planning additional clinical trials on Tasigna next year.

Glivec is approved for the treatment of Ph+CML and gastrointestinal stromal tumors (GIST). Glivec sales in the third quarter of 2012 were $1.2 billion.

We are encouraged by the company’s efforts to strengthen its position in the Ph+CML and CML area. With additional approvals and treatment options the company will be able to entrench its position in this crucial disease area.

Currently, we have a Neutral recommendation on Novartis. Novartis carries a Zacks #3 Rank (Hold) in the short run. Other pharma companies like Sanofi (SNY - Analyst Report), Roche (RHHBY) and Bayer (BAYRY - Analyst Report) carry a Zacks #2 Rank (Buy).