UR and pharmaceutical heavyweight Pfizer Inc. have successfully negotiated a patent license allowing the company to market a new drug based on university research for the treatment of menopausal hot flashes.
Under the terms of the nonexclusive license, Pfizer will pay the university an initial fee and two clinical milestone payments to be made when the drug clears important Food and Drug Administration barriers.
When the FDA approves the drug for the treatment of hot flashes, Pfizer will pay royalties to the university based on drug sales. University officials and experts believe that the license could become one of the most profitable in UR history.
“In terms of where this deal stands in relationship to other UR deals, it could become one of the top income-producing deals – probably in the top three,” Senior Manager of Biomedical Licensing at the Office of Technology Transfer Claudia Stewart said. “One estimate is that a non-hormonal drug alternative could probably capture a billion dollars of the hot flash market in about five years.”
Currently, UR has earned about $120 million in almost 15 years from a license to the pharmaceutical company Wyeth for vaccines such as Prevnar, which protects children from pneumococcal disease, including bacterial meningitis. This remains the university’s most profitable license.
UR’s share in the sales of the hot flash drug must remain undisclosed. “By the agreement, we’re bound not to reveal financial terms,” Stewart said. “We will get a substantial upfront payment. When the first milestone is achieved, we get another and we anticipate there being a substantial second milestone payment. Of course, there will be royalties on sales.”
Thomas J. Guttuso Jr., a neurologist at Strong Memorial Hospital, recognized an unusual connection between gabapentin, a compound used to treat seizures and migraines, and hot flashes in 1999.
A female patient who was prescribed gabapentin for headaches told Guttuso that the drug did a better job at controlling her hot flashes. He decided to investigate the connection.
Guttuso studied 59 women, who had more than seven hot flashes a day, during the 12-week research period. The women kept diaries and recorded the frequency of their hot flashes. Patients were either assigned gabapentin or a placebo that appeared identical to it.
Women who took gabapentin reported significantly less frequent and less severe hot flashes.
Guttuso theorizes that gabapentin works on calcium channels in the hypothalamus, the brain’s temperature regulatory center. Gabapentin’s interaction with these calcium channels may lead to a decrease in the release of brain transmitter chemicals called tachykinins.
The research was reported in the Feb. 2003 issue of Obstetrics and Gynecology. The research is regarded as a significant development for the estimated 40 million who are of menopausal age, who are looking for alternatives to hormone replacement therapy, which has recently been linked to an increased risk of heart disease and breast cancer.
UR was granted a “method of treatment” patent in 2001 that covers the use of drugs that treat hot flashes. In September, UR signed an exclusive licensing agreement with PharmaNova, a specialty drug company in Henrietta, N.Y. that allows the company to develop gabapentin specifically as a treatment for hot flashes.
Pfizer’s license is based on the development of a drug that does not use gabapentin. The license from UR is also nonexclusive, which allows the university to negotiate licenses with other companies.
The university and Pfizer remain entangled in a legal battle before the U.S. Supreme Court involving another method of treatment patent. UR sued Pfizer over their use of patented university research in their cox-2 inhibitor drug Celebrex, which relieves pain without causing inflammation of the stomach lining.
The university has said that the patent, if upheld by the courts, could become the most profitable university patent in history. Despite the legal imbroglio, university officials claim UR and Pfizer maintain a healthy relationship.
“In terms of this license agreement, we have a professional and respectful relationship,” Stewart said. “We were very happy that we were able to negotiate successfully on this technology.”
Stewart also believes that the legal battle will not affect the negotiation of other potential licensure deals between the two parties. “I think we deal with each technology independently,” Stewart said. “We are pleased that we were able to find a partner to commercialize this technology. I think it also brings to light the importance of university discoveries to large pharmaceutical companies.”
Tipton can be reached at
rtipton@campustimes.org.
