British Biotech Pipeline Close To Bearing First Fruit

As reported in last week's issue of the Marketletter, British Biotechhas filed its first approval dossier, with the European Medicines Evaluation Agency, for its acute pancreatitis drug Zacutex (intravenous lexipafant).

This is a real milestone for the company and means that it could have a revenue-bearing product on the market sometime in 1998, if the regulatory review runs smoothly. The application centers on the results of a Phase III UK study of the platelet-activating factor antagonist, which were reported last year. A full presentation of the data will be made at the American Gastroenterological Association's Digestive Disease Week in Washington DC on May 12.

British Biotech says that the manufacture of bulk and finished product is on target for the European launch next year. A second Phase III trial of lexipafant in acute pancreatitis is underway in the USA, and the company hopes to be able to file a New Drug Application with the US Food and Drug Administration in the next year. For the European launch, premarket activities are underway, including the recruitment of country managers for lexipafant.