German Authorities Probe Two Schering AG Drugs

Having temporarily taken Astra's injectable formulation of its antiulcerant Losec (omeprazole) off the market just two weeks ago (Marketletter August 8 and 15), Germany's regulatory authorities have launched an investigation into two of Schering AG's drugs, Diane 35 (cyproterone acetate and ethinylestradiol) for acne or acute facial hair in women, and Androcur (cyproterone acetate) for benign prostatic hyperplasia or prostate cancer in men.

Shares in the company dropped 4.4% on the announcement, a fall reflecting the fact that these two products achieve annual sales of around 400 million marks ($250 million), of which 25% comes from the German market. The products account for about 7% of the group's total business.

The regulatory authorities decided to initiate a review of the two products' safety after in vitro trials carried out by German and Italian researchers highlighted a possible risk of liver cancer. An Italian study published earlier this year, by researchers at the Institute of Pharmacology at the University of Genoa, showed changes in human liver cells when they were challenged with cyproterone acetate. A second study, performed by the publicly-funded Society for Radiation and Environmental Research near Munich in Germany, showed that similar changes were observed in rat liver cells confronted with the compound.