Pfizer’s highly anticipated developmental drug torcetrapib might not reach the market until 2011, according to some Wall Street estimates.
It is possible that the FDA may need until 2008 to finish an evaluation of imaging studies on torcetrapib to determine whether the drug removes plaque from arteries, Pfizer R&D president John LaMattina said during a conference call with analysts.
This means it could take until late 2009 before studies are fully completed, pushing back torcetrapib’s approval to 2010 or 2011, UBS analyst Roopesh Patel wrote in a note to investors.
Patel downgraded his rating on Pfizer stock to “neutral” from “buy,” partly because of this scenario.
Analysts estimated that sales of a new drug combining torcetrapib and Lipitor could reach $15 billion annually within a few years and help offset losses Pfizer will face when Lipitor goes off patent in 2010.
“For Pfizer, it all comes down to replacing Lipitor,” Raymond James analyst Michael Krensavage told Bloomberg.com. “Pfizer is counting on this compound to do that.”
Pfizer is expected to file its torcetrapib application with the FDA in late 2007.
Meanwhile, Pfizer has pushed back its Exubera timetable again saying that full roll-out of the inhalable insulin product will not come before early 2007.
“An expanded [launch] of Exubera to US primary care physicians, previously targeted for November, will begin next January,” the company said in its third-quarter statement.
Exubera, approved in February for use in Type 1 and Type 2 diabetes, was set to reach pharmacy shelves by mid-July. Pfizer changed the date to early September and then November before announcing the new delivery time of January, which is nearly a year after US approval.
The company said it has encountered “issues” with Exubera’s “innovative and complex manufacturing process” but has made “significant progress” in addressing these issues.
Exubera is sold in several European markets, and a comprehensive education and training program for US physicians and patients is under way, Pfizer said.
The FDA advisory committee that reviewed Exubera prior to approval had registered concerns about its potential adverse lung effects.