Mixed Results for Pfizer Combo Pill

Timing is crucial. Depending on patent-challenge disputes, the key Lipitor patent in the U.S. will expire in March 2010. Another Lipitor patent has been overturned in court. Pfizer is appealing the decision to the U.S. Patent and Trademark Office. If Pfizer wins, that patent will remain in effect until June 2011.

It's not clear when the FDA might act on the combination pill, and several analysts are worried that Pfizer might be forced to push back its launch of the combination pill.

"We felt the company's tone [during an Oct. 19 teleconference] pertaining to Lipitor-torcetrapib was more cautionary, though this could well be a reflection of greater conservatism on the part of Pfizer's new leadership," UBS analyst Roopesh Patel wrote in a Oct. 24 report. He cut his rating to neutral from buy.

Patel had predicted Pfizer would file an application during the second half of 2007, receive an accelerated six-month review from the FDA and launch the drug in 2008. Based on Pfizer executives' recent comments, Patel now predicts the drug will reach the market in 2009. If the FDA requires more test data, the drug might be delayed until 2011, he says. Patel doesn't own shares; his firm has had a recent investment banking relationship with the company.

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