HOECHST-ROUSSEL's ENDOMETRIOSIS AGENT GESTRINONE is in Phase II testing in the U.S. as an anti-estrogen, weak anti-progesterone and weak androgen-antagonist steroid. Roussel UCLAF currently markets the product, also known in research as R2323, in Brazil. The company hopes to market it in France in 1988 and in the near future in South Africa, Belgium and Holland. In France, the product is trademarked by Roussel UCLAF as Nemestran. A U.S. trademark filing for that name published for opposition under the international classification appeared in the April 14 "Official Gazette of the Patent and Trademark Office." A 35-patient study recently published in the "British Medical Journal," showed that there was no progression of the disease in the 18 patients receiving gestrinone, compared to a deterioration in eight of the 17 patients prescribed placebo. The study compared the gestrinone results to a deterioration rate of 23% in untreated patients. The study showed a difference in the elimination of the endometriosis favoring the gestrinone group, but the difference was not statistically significant. A significant difference in improvement of the disease with use of the drug was found, and the study concluded that gestrinone is an effective treatment of endometriosis. The British study (at Jessop Hospital for Women in Sheffield) is described as the first double blind, randomized placebo controlled trial of any treatment of endometriosis.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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