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1994.05.16 : Donation of U.S. Patent Rights for RU-486 to Population Council

Contact: IOS Press Office		Victor Zonana
Monday, May 16, 1994                    (202) 690-6343


     ROUSSEL UCLAF DONATES U.S. PATENT RIGHTS FOR RU-486 TO
                         POPULATION COUNCIL

     HHS Secretary Donna E. Shalala announced today that French
pharmaceutical company Roussel Uclaf, at the encouragement of the
Clinton administration, is donating, without remuneration, its
United States patent rights for mifepristone (RU-486) to the
Population Council, Inc., a not-for-profit corporation.

     RU-486 has been marketed for non-surgical termination of
pregnancies in France, the United Kingdom and Sweden.  The drug is
also under study for labor induction, contraception, Cushing's
syndrome, endometriosis, meningioma and breast cancer.

     "We strongly believe that women in America should have access
to the full range of safe and effective alternatives to surgical
abortion," Shalala said.  "The donation announced today is a big
step in that direction."

     On Jan. 22, 1993, President Clinton signed a Presidential
Memorandum directing the Department of Health and Human Services to
assess initiatives to promote the testing and licensing of RU-486 in
the United States.  

     Shalala commended Roussel Uclaf and the Population Council for
coming to closure after months of complex negotiations amid repeated
urging from the Clinton administration.

     Shalala emphasized, however, that the donation does not mean
RU-486 has been approved for use in the United States.  The
Population Council must conduct clinical trials, identify a
manufacturer and submit a new drug application to the Food and Drug
Administration.

     "The FDA will do all it can to quickly evaluate mifepristone,"
said Shalala.  "FDA's decision will be based solely on the
scientific and medical evidence as to the safety and efficacy of the
drug.  That is our responsibility to the women of America."


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                           HHS FACT SHEET




               Mifepristone (RU-486):  Brief Overview

                   
May 16, 1994                       Contact: FDA Press Office
                                            (301) 443-1130           
                 

     On Jan. 22, 1993, in one of his first official acts, President
Clinton issued a memorandum directing HHS Secretary Donna E. Shalala
to assess initiatives to promote the testing and licensing of
mifepristone (RU-486) in the United States.  

     During early 1993, Secretary Shalala and FDA Commissioner David
Kessler communicated with senior Roussel Uclaf officials to begin
efforts to pave the way for bringing RU-486 into the American
marketplace.

     In April 1993, representatives of FDA, Roussel Uclaf and the
Population Council, a not-for-profit organization, met to discuss
U.S. clinical trials and licensing of RU-486.  Over the last year,
the parties continued their negotiations, culminating in the
donation announced today.  Roussel Uclaf will transfer, without
remuneration, its United States patent rights to mifepristone to the
Population Council.  In turn, the Population Council will take the
necessary steps to bring RU-486 to the American market.

     Mifepristone was developed by the French firm Roussel Uclaf. 
The drug has been marketed for use to non-surgically terminate
pregnancy in France, the United Kingdom and Sweden.  There are
several investigative trials underway with FDA for other uses of the
drug, including contraception, labor induction, Cushing's syndrome,
endometriosis, meningioma and breast cancer.

     It must be recognized that termination of a pregnancy is not a
simple medical procedure, whether it is done surgically or through a
medical regimen.  In France, the United Kingdom and Sweden, where
RU-486 has been administered to approximately 150,000 women, the
procedure requires several visits to a medical facility, a precise
dosing scheme using two different drugs, and close monitoring to
care for women who may experience excessive bleeding or other
complications. Any use of mifepristone in the United States would
have to follow the same type of strict distribution and use
conditions.


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