Novartis (NVS) faced a pipeline setback recently as it announced discontinuation of a late-stage study (ENESTg1) of its drug Tasigna on the recommendation of an independent data monitoring committee. The study evaluated Tasigna versus Glivec as a first-line treatment for unresectableor metastatic GIST (gastrointestinal stromal tumor), a form of stomach cancer.
Both Tasigna and Glivec are currently marketed by Novartis. Tasigna is marketed for the treatment of first and second line chronic myeloid leukemia (CML) and Glivec is marketed both for CML and adjuvant treatment of GIST. Glivec is considered the current standard of care for the treatment of GIST.
The trial was stopped as interim data from the trial hinted that Tasigna was unlikely to show any superiority over Glivec. The primary endpoint of the trial was a comparison of progression-free survival between Tasigna and Glivec when used as initial therapy in these patients.
Novartis is banking on new drug approvals and successful label expansions to overcome the adverse impact of the upcoming patent cliff. Pipeline setbacks like this can be a blow to the company’s plans.
In another such pipeline setback, Novartis recently announced amendment to its supplemental new drug application (sNDA) for Afinitor tablets. Novartis was seeking approval from the US Food and Drug Administration (FDA) for the treatment of patients with advanced neuroendocrine tumors (NET) of gastrointestinal, lung or pancreatic origin. The amendment is now limited only to treat patients with advanced NET of pancreatic origin. The amendment by Novartis suggests that Afinitor may not be approved for the treatment of patients with advanced neuroendocrine tumors (NET) of gastrointestinal and lung origin, thus reducing the patient population for the drug.
Afinitor is currently marketed for the treatment of advanced renal cell carcinoma (RCC; kidney cancer) after treatment with an anti-VEGF therapy like Pfizer’s (PFE) Avastin, Sutent or Onyx Pharmaceuticals/Bayer’s (ONXX/BAYRY) Nexavar. Afinitor is also marketed for the treatment of subependymal giant cell astrocytomas (SEGA), a benign brain tumor associated with tuberous sclerosis (TS).
Meanwhile, Novartis announced some positive news. Data from a late-stage, two-year trial (FREEDOM) demonstrated that Novartis’ multiple sclerosis (MS) drug Gilenya delayed the progression of disability both in previously treated MS patients as well as those who had received no prior treatment. Gilenya is currently marketed for first-line treatment for relapsing forms of multiple sclerosis in 35 countries including US, Canada and Germany.
Our Recommendation
Currently, we have a Neutral recommendation on Novartis, which is supported by a Zacks #3 Rank (short term “hold” rating). We are pleased with Novartis’ wide range of products and its efforts to diversify further as is evident by the acquisition of eye-care company Alcon. However, we prefer to remain on the sidelines due to the imminent patent cliff faced by Novartis.
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