Lilly decision spells end for inhaled insulin
pharmafile | March 12, 2008 | News story | Research and Development |Â Â Â
Regulatory problems and doubts about commercial potential have led Lilly to abandon its late-stage inhaled insulin product.
The AIR insulin product, co-developed with Alkermes, had reached phase III development, but doubts about the future of inhaled insulin multiplied last year when Pfizer decided to pull Exubera from the market.
Exubera was the first inhaled insulin, but failed to catch on with doctors or patients and was withdrawn in mid-2007.
Lilly has stressed that it is cancelling the product not because of safety concerns, but because of "increasing uncertainties in the regulatory environment" and following a re-evaluation of the commercial and clinical potential of the product compared to existing insulin products.
"This decision, though difficult, is the right one to make at this time," commented John Lechleiter, Lilly president and chief operating officer. "Over the past several months we have conducted a thorough review of all aspects of our efforts to develop our AIR Insulin product and have now made the decision that it would be inappropriate for the company to continue development activities in connection with this project."
Lilly is currently contacting the clinical investigators conducting the current AIR Insulin clinical trials. Then, subject to protocols, will halt the trials and the patients currently enrolled will be moved to other insulin therapy under the supervision of their physicians.
Lilly's decision looks to be the end of the line for inhaled insulin, at least until further technological advances.
The AIR product was the second and final inhaled insulin to be scrapped following Exubera's failure on the market.
In January this year rival diabetes specialist company Novo Nordisk announced it was abandoning its AERx inhaled insulin, citing similar doubts about commercial viability.
