Pfizer Antipsychotic Gets New Approval

Forbes Magazine - Matthew Herper, 08.23.04, 2:20 PM ET

Pfizer announced that it has received clearance from the U.S. Food and Drug Administration to market its antipsychotic Geodon for acute bipolar mania, when patients suffer from unnatural highs that can last for a week or more.

Decision Resources, a Waltham. Mass.-based market research firm, estimates that the market for bipolar meds could be $3 billion by 2011.

The drug giant received the FDA approval on Thursday, but waited until today to make an announcement.

New York-based Pfizer (nyse: PFE - news - people ) hopes the new approval will help it re-ignite sales of Geodon, which has never managed to gain more than a foothold in the antipsychotic market ruled by Eli Lilly's (nyse: LLY - news - people ) Zyprexa and Johnson & Johnson's (nyse: JNJ - news - people ) Risperda. One selling point: Geodon supposedly causes less weight gain than either.

Because antipsychotic meds often cause patients to gain a lot of weight, many doctors, including the American Diabetes Association, worry that they lead to health problems such as diabetes and heart disease.

According to John Newcomer, a psychiatrist at Washington University in St. Louis: "We're doing too much research in this area to not see weight and metabolic problems as the key safety and tolerability issue for these drugs, particularly in light of all the U.S. public health services interest in the metabolic syndrome and the prevention of cardiovascular risk."

In a research note published this morning, Robert Hazlett, an analyst at SunTrust Robinson Humphrey, characterized the new approval as "helpful, but no blockbuster indication." Hazlett wrote that a higher starting dose of Geodon is being used in bipolar disease than in schizophrenia. "This higher starting dose appears to be leading to higher adverse events." Among the potential problems: A set of nervous system problems that can include muscle spasms, tremors, or involuntary facial movements.

Washington University's Newcomer disagrees. All of the drugs cause these neurological symptoms as the dose increases, he says.

Hazlett forecasts 2007 Geodon sales of $700 million, and rates Pfizer a "buy." An affiliate of SunTrust has been paid for services other than investment banking for Pfizer in the last 12 months.

Prescriptions of Geodon have been rising three times faster than the rest of the antipsychotic market. In 2003, Geodon had sales of $353 million. Pfizer is also developing a second antipsychotic, asenapine, with Akzo Nobel (nasdaq: AKZOY - news - people ).

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