Bayer/PPL's rec-AAT gets orphan status in EU

Following successful completion of Phase I clinical trials of theirrecombinant human alpha 1-antitrypsin aerosol formulation, Bayer and PPL Therapeutics have received a positive opinion from the European Medicines Evaluation Agency's Committee for Orphan Medicinal Products for the indication of treatment of emphysema secondary to congenital AAT deficiency.

PPL signed an agreement with Bayer last year (Marketletter August 21, 2000) which involved the development of an aerosolized formulation of PPL's transgenically produced AAT. Pivotal Phase III trials for rec-AAT aerosol formulation are expected to begin in the third quarter of 2001 and, upon marketing authorization approval, both companies would get up to 10 years market exclusivity in the European Union for the drug in the treatment of congenital emphysema.