Northwestern has the patent for a wonder-drug that industry analysts say could make billions of dollars a year, potentially bringing hundreds of millions of dollars to NU.
Pregabalin, a drug developed in 1989 by biochemistry Prof. Richard Silverman, is currently undergoing clinical trials at Pfizer Inc., the world’s largest drug company. Pfizer officials told the company’s shareholders Tuesday that they plan to file for approval from the Food and Drug Administration by the end of the year, said Arthur Pancoe, who identifies breakthrough drugs in their early development as a senior managing director at Bear, Stearns and Co.
If the FDA grants approval for pregabalin, Pancoe estimated the drug could bring in $4 billion to $6 billion a year – a portion of which would go to NU. While optimistic, those involved in the drug’s production said its success is in no way guaranteed.
Though NU administrators declined to comment on what percentage the school would receive, Bryan Renk, director of patents and licensing at the University of Wisconsin, said most universities receive between 3 and 5 percent – which means NU could receive $120 million to $300 million a year if Pancoe’s estimation proves correct.
“I can’t tell you how significant it is to the university – I’m smiling,” said Pancoe, who taught mathematics at NU from 1946 to 1952 and recently donated $10 million to the construction of the Pancoe Life Sciences Pavilion.
The drug, developed by Silverman for much less applicable purposes, is being tested for three uses: anti-epilepsy, anti-anxiety and neuropathic pain relief, something for which a “good drug” has not yet been found, Pancoe said.
Neuropathic pain results from disease damage to nerves, such as that caused by diabetes, and is not affected by aspirin, Silverman said. It can include back pain and any “intangible pains that just won’t go away,” Pancoe said.
“I told students (at a conference) last year that I thought it was the most significant drug ever developed at any university, maybe by a multiple,” Pancoe said. “I’ve been telling (University) President (Henry) Bienen and the board for several years. I went out on a limb early, because all these things can go wrong.”
In clinical trials, pregabalin is holding its own against and even faring better than marketed treatments such as the anti-anxiety drug Xanax and the antidepressant Effexor, according to a Wall Street Journal article printed Tuesday. In treating anxiety, pregabalin is reported to work faster than either Effexor or the antidepressant Paxil, drugs that can take more than a month to begin working and often have sexual side effects, according to the article.
Pregabalin also is less likely to become addictive and causes less sedation and cognitive impairment than its competitors, Pancoe said.
In addition to generalized anxiety, Pfizer also hopes to use the drug to treat spinal, cancer and surgical pain, as well as social anxiety and panic disorder, Pancoe said.
Pfizer officials did not return calls for comment.
If approved, pregabalin could replace Pfizer’s drug Neurontin, its current leading anti-epilepsy drug, Pancoe said. Neurontin, which earned $1.49 billion in sales last year, is derived from gabapentin, a drug that is chemically similar to pregabalin, Silverman said.
The money that pregabalin potentially could make for NU has a chance to put the university near the top of the list for licensing income. In 2000, the University of California system earned about $261 million and Columbia University earned about $138 million, according to The Chronicle of Higher Education. NU earned slightly more than $1 million that year, making it 71st on the list.
According to NU policy, 35 percent of revenue would be money that could be used anywhere in the university. Twenty percent of annual licensing revenue would go to the Technology Transfer Office, which provides resources for NU faculty and students to patent their discoveries.
After that deduction, 50 percent of the pregabalin income would go to Silverman: 20 percent for his research and 30 percent as personal income.
An additional 10 percent would go to the biochemistry department, and another 5 percent would go to Weinberg College of Arts and Sciences.
Pfizer would benefit even more from the drug’s success. For the past 10 years, three companies have poured their energies and funds into pregabalin – first Parke-Davis, then Warner-Lambert Co. and finally Pfizer.
Silverman himself has had little research use for the drug since he discovered it, though he did recognize its potential.
“I did design it as a new mechanism of action, and so I thought it would be worth having it tested, and that’s when I contacted Parke-Davis to have it tested and got lucky,” Silverman said. “What I had made it for was to get some information about compounds that interact with two different enzymes. Once I had that information, then I went and did other things.”
Silverman said he has high hopes for the drug’s success.
“It’s still not a sure thing,” he said. “(But) every time they do an experiment, it’s one less problem to cross.”
Daniel Linzer, a biochemistry professor who will become dean of Weinberg in July, said the drug is remarkable because it can attack multiple health problem areas.
“That’s why this has the potential to be a major pharmaceutical and have a major impact on the university, as well as on human health,” he said. “(But) there are a lot of promising things that at the last stages don’t make it.”
Alan Cubbage, university vice president for media relations, said pregabalin could add prestige to NU.
“Any time that there is a scientific advance that is at least potentially helpful to the world at large and the health of millions of people – that obviously is a benefit to the university, not just financially but in terms of its reputation,” Cubbage said. “If this proves to be successful, that’s just another laurel for the university’s reputation.”
The Daily’s John J. Hughes III contributed to this report.
