The US Food and Drug Administration (:FDA) recently accepted Pfizer Inc.’s (NYSE:PFE - News) New Drug Application (:NDA) for tafamidis meglumine. Pfizer is looking to get tafamidis approved for transthyretin familial amyloid polyneuropathy (TTR-FAP).
Tafamidis became a part of Pfizer’s portfolio with its October 2010 acquisition of FoldRx. TTR-FAP is a progressively fatal genetic neurodegenerative disease.
Tafamadis, which gained approval in the EU in November 2011, faced a setback last year in the US when the FDA issued a “refusal to file” letter for the company’s new drug application for the candidate. At that time, the FDA had said that the application, which was submitted in Feb 2011, was incomplete.
Pfizer gained priority review status for tafamadis which means a response from the FDA should be out in June 2012. Tafamadis enjoys orphan drug status in both the US and the EU. It is estimated that about 8,000 people across the world suffer from TTR-FAP. With tafamadis targeting a small patient population, we do not expect significant sales from the product.
Neutral on Pfizer
We currently have a Neutral recommendation on Pfizer, which carries a Zacks #3 Rank (short-term “Hold” rating). The company is going through a challenging phase following the November 2011 patent expiry of its mega blockbuster cholesterol treatment, Lipitor.
Near-term earnings at Pfizer will be driven by cost cutting efforts and share repurchases. While Wyeth brings with it an attractive biologics platform and some complementary products and businesses, we do not believe they are enough to sustain long-term top-line growth. We see the merger as mostly an opportunity for Pfizer to cut additional costs. Longer-term growth will be dependent on the success of drug development.
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