Northwestern can expect to see royalties from its much-touted drug Lyrica — generically called pregablin — by next September, University President Henry Bienen revealed to The Daily in a recent interview.
The Food and Drug Administration has not yet approved the drug for sale in the United States, but Lyrica is now available in Europe after the European Union’s European Commission approved the drug in July for neuropathic pain as well as treatment for partial seizures.
In the United States, Pfizer Inc., which will distribute the drug, said it already has received “approvable letters” from the FDA for Lyrica’s treatment of neuropathic pain and partial seizures.
Pfizer is still waiting for the drug’s approval for treatment of generalized anxiety disorder.
“People tell me it will (be approved in the United States),” Bienen said. He added he is certain Lyrica will receive approval from the FDA.
In a press release, Pfizer said it is “continuing to work closely with the FDA during the ongoing regulatory review to resolve open issues.”
Bienen said it is impossible to predict how much money Lyrica will bring to NU, but he said the university will receive 6 percent of the drug’s yearly revenue. Datamonitor, a London business-information company, projected in a July 2003 report that the drug could earn $760 million in 2005, increasing to $1.9 billion per year by 2008.
“We haven’t seen a check yet,” Bienen said. “It’s very hard for us to understand the implications of what the revenue stream might be.”
The money, when it hits university coffers, will be the first since the drug was developed 15 years ago by a researcher at NU. Pfizer submitted Lyrica for FDA approval in November 2003.
Royalties from Lyrica largely will be funnelled into NU’s almost $3.6 billion endowment for the “long-run strength of the university,” Bienen said. NU’s endowment is considerably smaller than its peer institutions — something Bienen has expressed concern about in the past.
Lyrica revenue also will fund graduate fellowships and campus construction projects, such as expanding Norris University Center and erecting a new building next to Regenstein Hall for the School of Music, Bienen said. But because of the uncertainty of Lyrica’s potential, NU is considering giving up its rights to revenue from drug sales to a company in exchange for a lump sum.
“There are lots of companies that have come forward to us and said, ‘We’ll give you ‘X’ if you give us your rights,” said Bienen, calling it “one of the most momentous decisions facing this university.”
Reach Dan Strumpf at [email protected].
Quick facts:
Lyrica was developed by in 1989 by NU Prof. Richard Silverman.
Pfizer is marketing the drug for NU and submitted it for FDA approval in November 2003.
Lyrica — also called pregablin — can be used to treat partial seizures and neuropathic pain.
