Pfizer Inc. researchers have determined that a drug discovered by a Northwestern chemistry professor –which could bring hundreds of millions of dollars to the university annually — is safe enough to seek federal approval.
If pregabalin gains approval and sells as well as Pfizer expects, NU would receive 6 percent of the drug’s estimated $4 billion to $6 billion in projected revenues by next year.
Pregabalin was in late-stage testing in September when researchers discovered it caused cancerous tumors in mice. Pfizer planned to apply for Food and Drug Administration approval in December but postponed filing until March to make sure tumors did not develop in other mammals.
“No tumors were found in any other mammalian species tested,” said Indrani Mukharji, director of NU’s technology transfer program.
Prof. Richard Silverman, who discovered pregablin, wrote in an e-mail that the tumors only occurred in one strain of mouse that “supposedly, gets tumors from many drugs.”
A Pfizer spokeswoman said the company will submit the drug for approval in Europe in March, then file an application in the United States.
Securing FDA approval will allow Pfizer to market the drug, which will be used for treating neuropathic pain and general anxiety disorders and as a component of epilepsy therapy.
The drug has proven useful for treating multi-symptomatic conditions because it simultaneously can treat different health problems such as pain and sleep disorder.