Dosing snafus during a pediatric trial of Geodon may end up costing Pfizer (NYSE: PFE) that coveted six extra months of U.S. exclusivity, consultants tell the Financial Times. And that loss would cut up to $500 million off the antipsychotic drug's sales figures, the industry experts say.
The FDA sent a warning letter to Pfizer, citing the company for violations of good clinical practice during two Geodon trials in children. Those trials, which tested the drug in patients with bipolar disorder and schizophrenia, were designed to help Pfizer nab new pediatric indications for the drug--and to get the company the chance to sell Geodon without generic competition for six additional months. "It would be a big blow not to get this," one of the consultants tells the FT.
Now that the FDA has raised questions about the conduct of these trials, the agency might not consider their data reliable, the consultants say. And the FDA tells the FT that, in general, pediatric exclusivity doesn't depend on positive trial results, but on completion of studies "in a manner consistent with good scientific practices." A flawed pediatric study could be grounds for denying exclusivity, the agency adds.
For its part, Pfizer says it's evaluating the warning letter and plans to respond to the agency within two weeks. The company tells the FT that it believes in the clinical integrity of its Geodon testing in children. "We are responding to the FDA's queries around the study and continue to plan to seek a pediatric indication for Geodon," the company says.
- see the FT coverage