European Commission approves Exubera inhaled insulin

The European Commission has approved Exubera (inhaled human insulin) for the treatment of adults with type 1 and type 2 diabetes.

Exubera, product of a collaboration between Pfizer Inc and Nektar Therapeutics, is the first non-injectable, inhaleable form of insu-lin to be approved since the discovery of insulin in the 1920s. Bespak, in conjunction with Nektar Therapeutics, developed the manufacturing process for Exubera's inhalation device and the company will manufacture the device at its 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 that does not require batteries or electricity. The inhaler is designed to deliver an accurate and precise dose of insulin each time it is used.

'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, and manufactures the inhalation devices. Nektar will receive royalties on all marketed products as well as revenue for the manufacture of the powders and the inhalation devices.

Exubera is pending approval in the US. In September 2005, the US FDA Advisory Committee recommended that Exubera should be approved for the treatment of adults with type 1 and type 2 diabetes.