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Novartis (NVS) Receives EC Nod for Tasigna Label Expansion

Zacks Equity Research

Novartis AG NVS announced that the European Commission (EC) has approved Tasigna for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) and pediatric patients with Ph+ CML-CP with resistance or intolerance to prior therapy including imatinib.

An approval was in the cards as European Medicines Agency's Committee for Medicinal Products for Human Use had given a positive opinion on the same.

We note that Tasigna is already approved for the treatment of chronic phase and accelerated phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) in adult patients, resistant or intolerant to at least one prior therapy, including Glivec. It is also approved for the treatment of adult patients with newly diagnosed Ph+ CML in chronic phase.

The drug is also approved in the European Union for the treatment of Ph+ CML in the chronic phase in pediatric patients with resistance or intolerance to prior therapy including Glivec.

Hence, a label expansion for the treatment of children with CML will boost sales of the drug given limited treatment options for the same.

In June 2017, Tasigna became the first and only TKI to include information on stopping therapy in adult patients with Ph+ CML-CP in both the first-line setting and after switching from Glivec in the EU label.



Novartis’ stock has rallied 3.7% year to date compared with the industry’s  6.8% gain.

We remind investors Novartis broadened its oncology portfolio by acquiring GlaxoSmithKline plc’s GSK certain oncology products and pipeline compounds in March 2015 after having divested its Animal Health Division to Eli Lilly and Co. LLY.  In the first half of 2017, Novartis announced that it is mulling strategic options for Alcon which includes retaining the business separation via capital market transactions such as a spin-off or an initial public offering. The company believes that the Alcon division has revived and hence a decision on a possible spin-off will be taken in 2019. The recent approvals of Kymriah and Kisqali will further boost the oncology portfolio and drive growth.

Zacks Rank & Key Pick

Novartis currently carries a Zacks Rank #3 (Hold).

A better-ranked health care stock is Sucampo Pharmaceuticals, Inc. SCMP which sports a Zacks Rank#1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Sucampo’s earnings per share estimates have moved up from $1.01 to $1.12 for 2017 and from $1.06 to $1.19 for 2018 over the last 60 days. The company delivered positive earnings surprises in three of the trailing four quarters, with an average beat of 15.63%.

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