) 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
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
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
) 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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