European Commission and FDA approve Exubera inhaled insulin

Both the US Food and Drug Administration (FDA) and the European Commission have approved Exubera (inhaled human insulin) for the treatment of adults with type 1 and type 2 diabetes. Exubera, the product of a collaboration between Pfizer Inc and Nektar Therapeutics, is the first non-injectable, inhalable form of insulin to be approved since the discovery of insulin in the 1920s. Bespak, in conjunction with Nektar Therapeutics, developed the manufacturing process for the inhalation device, which will be manufactured at Bespak's purpose-designed facility in Milton Keynes in the UK.

Exubera is a fast-acting powder formulation of human insulin that is inhaled into the lungs via the mouth before meals using a simple-to-use, hand-held inhaler, which is designed to deliver an accurate dose of insulin each time.

In clinical studies, Exubera reached peak insulin concentration more quickly than some regular insulins administered by injection. Peak insulin levels were achieved at 49 minutes (range 30 to 90 minutes) with Exubera, and at 105 minutes (range 60 to 240 minutes) with regular insulin.

'Exubera is a major, first-of-its-kind, medical breakthrough that marks another critical step forward in the treatment of diabetes,' said Hank McKinnell, Pfizer chairman and ceo. 'Exubera meets a critical medical need by offering a highly effective and needle-free alternative to diabetes pills and insulin injections to manage this complicated, debilitating disease.'

Pfizer is responsible for marketing, manufacturing and the clinical development of Exubera, while Nektar provides support in the manufacturing process for Exubera insulin. Nektar will receive royalties on all marketed products as well as revenue for the manufacture of the powders and the inhalation devices.