Lyrica, a drug created by Northwestern scientists, has been approved by the Food and Drug Administration, possibly providing the university up to $60 million a year in royalties from its sale.
Lyrica was approved Dec. 31 for treatment of neuropathic pain associated with diabetes and herpes. It is listed as a controlled substance — medication with a higher-than-average potential for abuse or addiction. NU will receive 6 percent of the drug’s revenue, currently estimated at $1 billion annually.
Royalties have already begun coming in from European sales of Lyrica, which was approved by the European Union’s European Commission in July for treating neuropathic pain and partial seizures.
The FDA has not yet approved other uses for the drug, including treatment for epilepsy and generalized anxiety disorder.
William McLean, NU’s vice president and chief investment officer, said the other uses will likely be approved later and called the delay “a timing issue.” NU has not adjusted its outlook on Lyrica, McLean said, and financial analysts probably have downshifted their expectations because the drug won’t immediately generate sales from epilepsy or anxiety disorder treatment.
“It does seem like (the approval) does restrict doctors from giving as many prescriptions,” McLean said. “I think it might also limit (Pfizer’s) ability to advertise for the product. I think in terms of what the company was looking for, clearly they were looking for epilepsy and they didn’t get that.”
Chemistry Prof. Richard Silverman, who discovered the drug, said he sees no reason for those other uses not to be approved by the FDA.
“The FDA does what the FDA does,” he said. “From the clinical trial results that I’ve seen, certainly it’s outstanding as adjunctive therapy for partial seizures.”
Silverman said the clinical trials showed the drug also treated anxiety “very well” but required a higher dosage, and the FDA may be wary about approving that dosage. Still, he said, the trials showed no evidence that Lyrica would have the serious side effects of other drugs on the market, such as Xanax, which is addictive.
“I personally know several people that need this drug, and they’re waiting for it,” Silverman said.
Silverman and other inventors of the drug will receive 1.5 percent of the revenue Pfizer receives from Lyrica sales. The other 4.5 percent will go toward NU’s endowment, graduate fellowships and campus construction projects such as expanding Norris University Center, University President Henry Bienen told The Daily in an interview last spring.
At that time, Bienen said the university was considering selling its rights to Lyrica royalties for a lump sum due to uncertainty about the drug. A sale would guarantee NU some money if Lyrica doesn’t sell well but could result in less money than royalties if the drug is successful.
McLean said NU has received several offers but has not made a decision.
“It’s an ongoing analysis, so there’s no timetable on it, and (it depends) on what we find somebody was willing to pay for the royalty,” McLean said.
Reach Tina Peng at [email protected].
