Pfizer's (PFE) Palbociclib Has $5 Billion Potential

April 10, 2013 11:17 AM EDT
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This morning Pfizer Inc. (NYSE: PFE) announced its investigational compound palbociclib (PD-0332991), an oral and selective inhibitor of cyclin dependent kinases (CDK) 4 and 6, has received Breakthrough Therapy designation by the United States Food and Drug Administration. Commenting on the news, analyst Seamus Fernandez of Leerink Swann called the news a "clear positive."

"We are increasingly of the view that confirmatory interim PFS and safety data from the currently recruiting 450-pt Ph II/III first-line study of palbociclib + letrozole vs. letrozole alone would be sufficient to allow FDA approval. Given median PFS of 8-10 months with letrozole in the first-line setting, we assume data at 18 months (possible by late 2014/early 2015) would be sufficient for approval. We would view accelerated approval on the basis of Ph II data as an upside surprise," said Fernandez.

Fernandez thinks palbociclib could become a $5 billion drug, with potential for $3 billion in first-line metastatic breast cancer alone.

Leerink Swann has a Market Perform rating on Pfizer.

For an analyst ratings summary and ratings history on Pfizer (NYSE: PFE) click here. For more ratings news on Pfizer click here.

Shares of Pfizer closed at $29.11 yesterday.

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