Lilly to proceed with Alkermes' AIR technology

Eli Lilly has decided to proceed with significant investment for the further development of an inhaled formulation of insulin.

The decision follows the successful execution of several critical steps: the completion and analysis of data from a Phase II study; the achievement of commercial manufacturing powder production scale-up; and the development and testing of a commercial pulmonary insulin inhaler system from US biotech company Alkermes. Development activities will include both clinical trials and additional manufacturing activities for the inhaler system and the production facility.

A recently completed Phase II clinical trial for inhaled insulin using Alkermes' AIR technology showed that patients with type 1 diabetes achieved glycemic control levels similar to injected insulin. The trial was a multi-centre, cross-over design study with 120 patients with type 1 diabetes receiving an inhaled formulation of insulin using AIR technology for a three-month period. Inhaled insulin had a rapid onset of action and was well tolerated with adverse events similar in both treatment arms.

'We're delighted that the strength of the clinical data and our achievement of commercialisation milestones provided the basis of the decision by Lilly to move forward with further development for inhaled insulin,' said Dr Elliot Ehrich, chief medical officer at Alkermes. 'We look forward to initiating additional clinical studies that will bring us another step closer to developing an important new treatment for the growing number of people living with diabetes.'

The inhaled insulin delivery system is based on Alkermes' AIR pulmonary drug delivery technology, which uses a small, easy-to-use, inhaler designed to provide drug delivery for a wide range of drug doses. Alkermes and Lilly have collaborated on the inhaled insulin program since 2001 to develop an innovative treatment option for people with diabetes.

About Diabetes

Diabetes is a group of diseases characterised by high levels of blood glucose resulting from defects in insulin production, insulin action, or both. According to the American Diabetes Association (ADA), diabetes can be associated with serious complications and premature death, but people with diabetes can take steps to control the disease and lower the risk of complications. Additionally, the World Health Organisation lists diabetes as one of the leading causes of mortality worldwide. Approximately 193m people around the world have diabetes, and this number is expected to double to 330m by the year 2025