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Pfizer (PFE - Analyst Report) recently received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for tafamidis meglumine. Pfizer is looking to get tafamidis approved for transthyretin familial amyloid polyneuropathy (TTR-FAP).

The agency has asked the company to complete a second efficacy study supporting the candidate’s effectiveness. The FDA has also asked Pfizer to provide additional information on data submitted as a part of the new drug application (NDA).

Tafamidis became a part of Pfizer’s portfolio with its October 2010 acquisition of FoldRx. TTR-FAP is a progressively fatal genetic neurodegenerative disease.

This is the second delay being faced by tafamidis in the US. Last year, the FDA had issued a “refusal to file” letter for the company’s NDA for the candidate. At that time, the FDA had said that the application, which was submitted in Feb 2011, was incomplete.

Tafamadis is already approved in the EU under the trade name Vyndaqel. 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.

Pfizer intends to seek a meeting with the FDA to determine the regulatory path for the candidate.

Neutral on Pfizer

We currently have a Neutral recommendation on Pfizer, which carries a Zacks #3 Rank (short-term Hold rating). The company is facing a major patent cliff with Lipitor losing patent protection in November 2011.

Competition in the generic market for Lipitor increased further with the recent launch of Mylan’s (MYL - Analyst Report) generic version of Lipitor. Near-term earnings at Pfizer will be driven by cost cutting efforts and share repurchases. Longer-term growth will be dependent on the success of drug development.

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