ANANXYL WITHDRAWN FROM MARKET IN FRANCE

Synthelabo has had its non-benzodiazepine anxiolytic drug Ananxyl (alpidem) withdrawn from the French market because of toxicity problems, the company said last week. The product licence was withdrawn because of a high incidence of liver toxicity in patients using the drug, invariably in association with other drugs. Synthelabo's shares fell 7.5% on the news (see page 9).

"Dear Doctor" letters were sent out in August in France, warning that a few cases of liver dysfunction had been seen with alpidem when used in conjunction with certain other drugs. In addition, alpidem trials in the USA, where it was being developed by Lorex Pharmaceuticals (the joint venture between Synthelabo and G D Searle), were stopped in 1992. At the time the company said it was because of "divergent results," and added that it would undertake a series of complementary studies in support of a New Drug Application. The withdrawal in France casts a shadow on the drug's prospects and it is highly unlikely to be developed further elsewhere.

Analysts Mark Tracey and Paul Krikler at Goldman Sachs believe that this marks the end for alpidem and that the group will discontinue its development outside of France. They also think that their view of Synthelabo as a market underperformer, with a weak product portfolio, is backed up by the news, although they note that cost-savings programs, product alliances and future growth in the USA and Japan may limit the adverse effects on profits.