Pfizer delays NU drug for further tests

Elaine Helm

Northwestern will have to wait longer than expected to cash in on the sale of a drug developed by an NU professor after some mice given the drug in testing developed cancerous tumors.

Pfizer Inc., the company that owns the rights to the drug pregabalin, which treats epilepsy and anxiety disorders, announced Sept. 6 that it will delay until March 2003 the filing of the Food and Drug Administration application that would allow them to market the drug. During the additional time, the company will conduct further tests.

Pfizer previously planned to submit the application in December 2002.

University President Henry Bienen told The Daily in May that NU would receive 6 percent of the revenue from the drug — a figure likely in the hundreds of millions. He said the university likely would use its share of revenue to expand the endowment, create graduate fellowships and provide funds for building maintenance.

Indrani Mukharji, executive director of NU’s Technology Transfer Program, said the delay will allow Pfizer to eliminate concerns about the toxicity of the drug shown in a specific strain of lab mice.

“They need to be absolutely sure that the toxicity shown … is limited to that strain,” Mukharji said. “All other mammalian species that they have tested this on haven’t had any problems.”

In addition to mice, Pfizer has tested the drug on monkeys, rats, dogs and humans.

NU Prof. Richard Silverman, who discovered the drug in 1989, said pregabalin appears to cause tumors in only one species of mice. He downplayed the significance of that finding and decried the delay for patients who might benefit from the drug.

“This is a very important drug,” Silverman said. “It’s going to help people who can’t be helped by any other drug on the market. It’s just a shame for these people to wait around for a few more months.”

Silverman said the drug’s most promising applications are the treatment of neuropathic pain, epilepsy and anxiety disorders.

Despite his disappointment, Silverman said delays of this kind are not unusual — the average time for a drug to move from discovery to the drug store is about 12 years.

A press release on Pfizer’s Web site contained little information about the delay, concluding simply: “We are confident pregabalin will meet all necessary testing requirements, and the additional studies … will enhance the review process and subsequent approval for the drug.”

Mariann Caprino, a spokeswoman for Pfizer’s corporate media relations, said Tuesday that the company had no further comment.

Because the drug still is being tested, Mukharji said she could offer little other information about the delay or the drug-testing process.

Due to the nature of the university’s agreement with Pfizer, neither Pfizer nor NU can disclose information on the drug until Pfizer secures FDA approval to market it, she said.

Healthcare industry analysts at Friedman, Billings, Ramsey & Co. called the delay a “mild setback” and continue to recommend Pfizer’s stock in a report released earlier this month. The report estimated that peak sales of pregabalin could reach $3 billion due to the low occurrence of side effects and high effectiveness demonstrated in human testing.