Look, Ma! No Torcetrapib Data!

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That’s right. Pfizer won’t have results from the Illuminate trial - the one that ended abruptly and dashed the drugmaker’s hopes - at the American College of Cardiology conference starting on March 24. At least that’s what Dave Risinger, industry analyst at Merrill Lynch, writes in an investor note this morning.

To wit, Pfizer told us “it will take time to fully adjudicate the data and further understanding of the program requires that the data be analyzed in full. As the data become available we will be working with investigators and experts to ensure a comprehensive analysis and will report through forums where scientific discussion and dissemination can occur.”

Two other studies will be shown at ACC, but these results probably won’t answer the mystery behind the higher mortality seen in the Illuminate trial. Was it plaque, blood pressure or something specific to the Pfizer drug? “Regardless of the data, debate and uncertainty surrounding the CETP inhibition mechanism will persist,” he writes.

The implications: the FDA is unlikely to allow Merck or Roche to start Phase III of their own CETP-inhibitors until it reviews the Pfizer trial. Risingers thinks the FDA will require five-year morbidity/mortality studies for their drugs, assuming the mechanism is viable. So maybe Merck and Roche will begin studies in 2008, but that suggests NDA filings in 2013.

Easy come, easy go.
[tags]CETP-Inhibitor, Merck, Pfizer, Roche, Torcetrapib[/tags]

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