EU GIVES GO-AHEAD TO PULMOZYME

The European Union's Committee on Proprietary Medicinal Products in Brussels, Belgium, has recommended approval for Genentech's new cystic fibrosis treatment Pulmozyme (dornase alfa). The CPMP members representing the 12 EU countries have said that the product meets the requirements for marketing authorization. Once launched, Pulmozyme will be marketed jointly by Hoffmann-La Roche and Genentech Europe in western Europe.

Pulmozyme is the first innovative therapy for cystic fibrosis in the last 30 years. The compound, a recombinant version of the human enzyme DNAse, breaks down the thick mucus that is produced in CF sufferers and as a result relieves congestion and reduces the incidence of serious lung infections. Remarkably, the development of the product has taken less than five years from its discovery.

Pulmozyme has also been approved by the US Food and Drug Administration, following a positive recommendation by an advisory committee to the agency in August (see pages 26-27). Genentech has exclusive rights to market the product in the USA and Canada, while Roche has exclusive rights outside western Europe, the USA and Japan.