Dr. Edouard Sakiz at Roussel-Uclaf and Prof. Etienne-Emile Baulieu initiated a major programme of chemical and biological research intended to develop a whole range of new steroid molecules with hormonal and anti-hormonal actions.
One molecule manifested very strong anti progesterone activity – code name RU-486 whose international non-proprietary name is mifepristone.
Dr.Sakiz, Prof.Beaulieu and members of their teams at Roussel-Uclaf and INSERM published the results of the first clinical trials on medical termination of pregnancy with mifepristone (RU-486).
In response to anti-abortion protests and concerns of majority of the shareholders of Hoechst AG (Germany), which acquired Roussel- Uclaf, the company decided to suspend RU 486 in October 1988. Few days later, the French Minister of Health declared that "RU-486 is also the moral property of women" and demanded continuation of plans for product distribution in the interests of public health. From that moment, Government approval for the drug was granted. RU-486 became the moral property of women, not just the property of a pharmaceutical company. Mifegyne® (mifepristone) in combination with an intravaginal or an injectable prostaglandin analogue is approved in December 1988 in Medical Termination of Pregnancy. Distribution is restricted to hospitals authorized to perform abortions.
Expansion was approved in Great Britain and Sweden.
Following safety issues with intra-muscular prostaglandin, a new clinical development with the orally active prostaglandin analogue, misoprostol, was initiated. For public health reason, the marketing authorization was granted to Mifegyne® in combination with misoprostol 400 mcg and the combination to the intra-muscular prostaglandin has been withdrawn.
Dr. Sakiz established the company Exelgyn in France to ensure the continued production, distribution and research and development of Mifegyne® worldwide (except for the USA). In the USA, the rights were handed over to “The Population Council”.
Mifegyne® has granted Marketing Authorizations and is available in several countries in and outside Europe (Austria, Belgium, Denmark, Finland, Germany, Greece, Netherlands, Luxembourg, Norway, Spain, Switzerland, Russia, Ukraine, Tunisia, Israel, South Africa, New Zealand...)
In May 2002 and July 2004 decrees and orders derived from the Law of 4th July 2001 authorise medical termination of pregnancy outside hospitals in France. Mifegyne® is then available from retail pharmacies to healthcare professionals. The product is increasingly used at home in Sweden, Germany and Switzerland.
The World Health Organisation (WHO) included mifepristone in the list of essential medicines.
Exelgyn began its collaboration with Nordic Drugs for the marketing and distribution agreement of Mifegyne® in the 5 Nordic countries. In 2009, this agreement is expanded to all European countries with Nordic Group.
Exelgyn was acquired by the Nordic Group. www.nordicpharmagroup.com
Approval of the first misoprostol product 400 mcg dosage officially indicated in medical Termination of Pregnancy up to 49 days of amenorrhea in a large number of countries. Those Marketing Authorizations are granted with the trade names:
Availabilities in new territories.
Product launch of MisoOne® / Topogyne® in Europe.