Genentech Inc. Monday announced that its Pulmozyme treatment foracute exacerbations of chronic bronchitis significantly reducedmortality, rehospitalizations and respiratory relapses in Phase II trials.The South San Francisco company (NYSE:GNE) cautioned, however,that a larger, more definitive Phase III trial is needed to confirm theresults.Michael Walsh, a biotechnology analyst with San Francisco-basedRobertson Stephens and Co., told BioWorld Today that there is a hugepotential market for this indication, though he, too, warned that it's tooearly to get too excited about the results."Using the figure cited by Genentech that there are 600,000hospitalizations each year in the U.S. for chronic bronchitis, andassuming an average cost of $750 per year per patient," Walshestimated, "the potential value of the treatment in the U.S. alone is$450 million - in addition to the cystic fibrosis market." The value ofthe market cystic fibrosis (for which the drug was approved last year)has been estimated at around $90 million in 1994 by other analysts.According to an abstract of the study prepared by researchers whoconducted the trials, "this early, limited clinical trial suggests animportant therapeutic role for rhDNase in the management of acuteexacerbations of this common chronic obstructive lung disease patientgroup." The Phase II double-blinded, placebo-controlled, multicenterstudy enrolled 244 patients with chronic bronchitis who had beenhospitalized due to acute respiratory exacerbation. It found that therewas a 59 percent reduction in mortality in patients taking the treatment,compared with those on placebo, and that this decrease in mortalitywas sustained over an additional four months of follow-up.No "untoward effects" were observed. Differences in time to resolutionand spirometric improvement did not reach statistical significance.Pulmozyme (dornase alfa) has been approved as a treatment for cysticfibrosis in Canada, Austria, Sweden, New Zealand and Argentina, inaddition to the U.S. Pulmozyme is marketed in Europe via a jointdevelopment and marketing agreement with F. Hoffmann-La RocheLtd.For both indications, Pulmozyme is administered as an aerosolnebulizer and absorbed through the nose. It is priced at $27 per 2.5 mgampoule.Laura Leber, a spokeswoman for Genentech, said some 5,600 patientsworldwide would be enrolled in the Phase III study, which is slated tobegin in the U.S., Europe and Canada in the fall. She noted that a PhaseII trial of Pulmozyme as a treatment for bronchiectasis is now underway.

-- Philippa Maister

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