Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Novartis (NVS) recently announced positive data on Zykadia from a phase I study. Data from the study showed that Zykadia was effective in extending the progression-free survival (PFS) of patients suffering from anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) for more than 18 months.
Meanwhile, two phase II single-arm clinical studies on Zykadia among previously treated and treatment-naïve ALK+ NSCLC patients have been fully enrolled and are ongoing. In addition, two phase III trials comparing Zykadia with chemotherapy in treatment-naïve as well as in previously-treated patients are enrolling.
We note that Zykadia was approved by the FDA in Apr 2014. Zykadia is currently under review in the EU. A potential approval in the EU will boost Novartis’ oncology portfolio.
Concurrently, Novartis also presented final results from a phase III trial, RADIANT-3, on oncology drug, Afinitor, among patients with well-differentiated, advanced and progressive pancreatic neuroendocrine tumors.
Data from the trial showed that patients treated with Afinitor showed an unprecedented median overall survival of 44 months, which, in spite of representing a clinically meaningful improvement, was not statistically significant.
This data presentation is an analysis of the mature overall survival results, which was also the secondary endpoint of the trial.
We note that Afinitor is approved for locally advanced, metastatic or unresectable progressive neuroendocrine tumors of pancreatic origin. It is also approved in the EU for the treatment of hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer in combination with Pfizer’s (PFE) Aromasin.
We cautiously watch Novartis' efforts to realign its portfolio in order to focus on its core business of pharmaceuticals, eye care and generics. We believe the recently announced acquisition of oncology products from GlaxoSmithKline (GSK) and divestment of the Vaccines business to be a step in the right direction. These are expected to broaden Novartis’ portfolio and enable it to emphasize on its core capabilities.
Novartis also entered into a definitive agreement with Eli Lilly and Co. (LLY) to divest the Animal Health Division for $5.4 billion in a separate transaction.
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