Pregabalin submitted for FDA approval

Dalia Naamani-Goldman

A Northwestern-developed drug is one step closer to neighborhood pharmacies — bringing with it the prospect of millions of dollars for the university.

Pregabalin, a drug developed by chemistry Prof. Richard Silverman in 1989, was submitted to the Food and Drug Administration last week by Pfizer Inc. for approval to treat neuropathic pain, epilepsy and generalized anxiety disorder. If approved the drug could hit the market by summer.

“We are all extremely excited,” said Indrani Mukharji, executive director of NU’s Technology Transfer Program, which markets research discoveries at NU. “We had hoped this would happen and finally it happened.”

Mukharji said she has been in frequent contact with University President Henry Bienen and other administration officials. Neither Vice President for Business and Finance Eugene Sunshine nor Vice President for University Relations Alan Cubbage would comment on the filing.

The FDA also does not comment on pending drug approvals, a spokeswoman told The Daily.

Pfizer, which conducted clinical trials for pregabalin across the country, is very optimistic about the drug’s potential, according to an Oct. 31 press release. The drug works to suppress symptoms of epilepsy and anxiety disorder by reducing pain transmission in the central nervous system.

“Our New Drug Application for pregabalin is supported by clinical studies involving more than 10,000 patients,” Dr. John LaMattina, president of Pfizer Global Research and Development, said in the press release. “In the area of neuropathic pain where current treatment options are limited, pregabalin’s clinical program represents the largest and most robust undertaken to date.”

Neuropathic pain is not caused by stimuli, but rather by internal nerve damage. Typical over-the-counter and prescription pain relievers often are insufficient to treat the severity of neuropathic pain, but some success has been found with prescribing anti-depressants and anti-epileptic drugs such as pregabalin.

NU will receive 6 percent of the drug’s yearly revenue, Bienen said last year. Datamonitor, a London-based business-information company, projected in a July 2003 report that pregabalin could earn $760 million in 2005 and increase to $1.9 billion per year by 2008.

Initial pregabalin revenue projections estimated the drug could bring in $4 billion to $6 billion total each year, which would yield NU $120 million to $300 million annually. Bienen has said in the past that NU’s royalties would go to the endowment and building funds and create more graduate fellowships.

Pregabalin currently has 17 different U.S. patents with more pending applications, Mukharji said. The drug also has 20 European patents. Patents are necessary to ensure NU’s ownership of the drug — which justifies the hundreds of millions of dollars invested in the pregabalin’s development, she said.

The most important of the patents, which covers the pregabalin molecule, will expire in 2018, Mukharji said. The drug must be successfully marketed before its patents expire if the university is to capitalize upon its profits. When a patent expires, no further royalties come from sales.

Pfizer intended to submit pregabalin to the FDA in December 2002 but was forced to conduct further research when tumors appeared in a certain species of mice during drug trials. Pfizer submitted the drug for neuropathic pain treatment and adjunctive therapy to the European Agency for the Evaluation of Medicinal Products, Europe’s equivalent of the FDA, in April 2003.

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