Rolling NDA for Pfizer Drug - Analyst Blog

Pfizer (PFE) recently announced that it has started a rolling submission for a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its lung cancer pipeline candidate crizotinib. The submission is expected to be completed in the first half of 2011.

Crizotinib is a first-in-class, oral anaplastic lymphoma kinase (ALK) inhibitor currently in phase III trials for the treatment of advanced non-small cell lung cancer (NSCLC). The candidate is also being studied in phase I trials for other tumor types.

A rolling NDA submission allows a company to file the completed portions of an NDA for an ongoing review by the FDA. A rolling NDA submission can be done only for drugs that have received Fast Track designation from the FDA. A Fast Track designation allows an expedited review of pipeline drugs that treat serious life-threatening diseases with significant unmet clinical need.

Pfizer also plans to file regulatory applications for other pipeline candidates, axitinib and bosutinib, in both the US and the EU, in 2011. Axitinib is an oral and selective inhibitor of vascular endothelial growth factor (VEGF) receptor, which is being developed for the treatment of advanced renal cell carcinoma.  Bosutinib, an oral dual Src and Abl kinase inhibitor, is being studied for the treatment of chronic myeloid leukemia (CML).

Neutral on Pfizer

We currently have a Neutral recommendation on Pfizer, which is supported by a Zacks #3 Rank (short-term Hold recommendation). While the Wyeth takeover brought with it an attractive biologics platform and some complementary products and businesses, we do not believe they are enough to sustain Pfizer's long-term top-line growth.

The Lipitor patent expiration in 2011 remains a big concern. Lipitor contributed almost 23% to the top-line in 2009 with sales coming in at $11.4 billion. The entry of generic versions of the product will have a significant impact on the company's financials. The loss of patent exclusivity over the coming years will make it challenging for the company to propel top-line growth.