Novo Nordisk has transferred to Aradigm, at no charge, its inhaled insulin portfolio after axing Phase III trials in May. Aradigm says that it is looking for another partner to continue development.
Finding a partner may be slim pickings, though. Novo cited that it did not believe that inhaled insulin would offer clinical or convenience benefits over injected insulin. This assessment was certainly true of the one approved inhaled insulin product, Exubera from Pfizer. Exubera had a very poor uptake and was recently linked to lung cancer and then subsequently withdrawn from the market.
Pfizer’s partner, Nektar, decided to nix efforts to find a partner for the treatment. Eli Lilly as well dropped development of its late-stage inhaled insulin program.
“We believe Aradigm’s pioneering team developed a strong intellectual property position in the area of inhaled drugs and inhaled insulins in particular, which was expanded during the collaboration with Novo,” states Igor Gonda, Aradigm CEO and president. “Aradigm’s inhaler has unique features including features to facilitate proper usage of the inhaler and convenient dosage flexibility.”
Novo purchased a significant portion of the portfolio from Aradigm in July 2006 and then supplemented it with its own related patents, which now includes U.S. and foreign patents. In the transfer, Aradigm will also receive a significant preclinical safety database that was developed during the companies’ collaboration, the rights to a miniaturized second-generation electronic insulin inhaler, and data from Novo’s inhaled insulin clinical program, which included nine Phase III trials in type 1 and type 2 diabetes patients.