Pfizer licenses drug from University of Rochester for treatment of hot flashes

The University of Rochester has signed a license agreement with Pfizer which will allow Pfizer to market a specific class of non-hormonal drugs for the treatment of hot flashes associated with menopause.

For tens of millions of women who suffer from hot flashes, such a drug would be a welcome alternative to hormone replacement therapy, which has been linked to an increased risk of heart disease and breast cancer in some patients.

The University of Rochester was granted a "method of treatment" patent in 2001 that covers the use of drugs that treat hot flashes by targeting a specific group of cells in the hypothalamus, the region of the brain that regulates body temperature. The proposed link between those cells and hot flashes was suggested by Thomas Guttuso, Jr., M.D., who had been conducting research in the University of Rochester’s School of Medicine and Dentistry as part of a fellowship program in Neurology.

Pfizer is developing a drug that quells hot flashes by targeting the mechanism covered by Rochester’s patent. Under the terms of the nonexclusive license, Pfizer will pay the University an initial fee, and two clinical milestone payments to be made when its drug clears important hurdles in the development process. If the Food and Drug Administration approves the drug for the treatment of hot flashes and it is brought to market, Pfizer will pay royalties to the University based on sales of the drug.

The Rochester patent received little attention when it was granted in 2001. That changed a year later, when two rigorous and widely reported studies challenged the safety of hormone replacement therapy. Millions of women have stopped taking hormone replacement as a result, and there is currently no non-hormonal drug alternative on the market.

There are currently about 42 million women in the United States who are over 50, the average age at which menopause begins. About three-quarters of menopausal women experience hot flashes. In 2002, before safety questions dampened sales, sales of hormone replacement drugs topped $3 billion, and the hormone replacement drug Premarin was the third-highest selling drug in the U.S.