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Positive Data on Novartis' Tasigna

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Novartis (NVS) recently presented positive data from three large randomized phases III studies (ENESTnd, ENESTcmr and LASOR) conducted on its oncology drug Tasigna.

The studies reinstated the superiority of Tasigna over Glivec in achieving deeper molecular responses across various patient populations affected by Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).

These patient populations included newly-diagnosed patients, patients with residual disease who switched to Tasigna after long-term treatment with Glivec, and patients who failed to respond to frontline Glivec.

The ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials - Newly Diagnosed Patients) compared the efficacy and safety of Tasigna versus Glivec in adult patients with newly diagnosed Ph+ CML in chronic phase. The data from the study indicated a trend for higher overall survival (:OS) and event-free survival (:EFS) rates in patients treated with Tasigna compared to patients treated with Glivec.

Novartis also presented data from the ENESTcmr (Evaluating Nilotinib Efficacy and Safety in Clinical Trials - Complete Molecular Response) study, which showed that Ph+ CML patients with residual disease following long-term treatment with Glivec achieved deeper molecular responses after switching to Tasigna.

Meanwhile, results from the LASOR (Imatinib Dose Optimization versus Nilotinib in CML Patients with Suboptimal Response to Imatinib) study compared the efficacy of Tasigna 400 mg twice daily to Glivec 600 mg once daily. The study showed higher rates of molecular response in patients who failed to achieve a cytogenetic response (CCyR) with frontline Glivec and switched to Tasigna compared to those whose dose of Glivec was escalated.

We note that Tasigna is approved for the treatment of chronic phase and accelerated phase Ph+ CML in adult patients, resistant or intolerant to at least one prior therapy, including Glivec.

Tasigna was one of the top-selling drugs for Novartis in the first nine months of 2013, generating sales of $914 million, up 33% from the year-ago period.

Sales of Glivec were down 1% due to loss of patent exclusivity in Brazil, Russia, Canada, Turkey and Mexico, and increased competition in the Ph+ CML indication.

We are encouraged by the results of the follow-up study on Tasigna, which showed its superiority over Glivec in treating Ph+ CML in adult patients and should help replace some of the lost revenues.

Novartis currently carries a Zacks Rank #3 (Hold). Some of the better-ranked stocks which look attractive at current levels include Bayer AG (BAYRY), Shire (SHPG), and Furiex Pharmaceuticals (FURX). All three carry a Zacks Rank #2 (Buy).

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