Bespak welcomes regulatory filing of Exubera

Published: 9-Mar-2004

Pfizer Inc and Aventis have announced that the European Medicines Evaluation Agency (EMEA) has accepted the filing of a marketing authorisation application for Exubera (inhaled human insulin powder). The companies are seeking approval to market Exubera to adult patients with Type 1 and Type 2 diabetes.


Pfizer Inc and Aventis have announced that the European Medicines Evaluation Agency (EMEA) has accepted the filing of a marketing authorisation application for Exubera (inhaled human insulin powder). The companies are seeking approval to market Exubera to adult patients with Type 1 and Type 2 diabetes.

UK-based Bespak will manufacture the drug delivery device for Exubera at its Milton Keynes manufacturing facility under an arrangement with Nektar Therapeutics, which developed the device and formulation. The timing of full scale production is as yet unknown and will depend in part on the speed of the regulatory review process.

Pfizer and Aventis have also been working with the US FDA to determine the appropriate timing for submission of the Exubera new drug application in the US.

Mark Throdahl, Bespak's chief executive, said: 'We are delighted with the European filing of Exubera and look forward to participating in the commercial success of the drug by supplying its delivery device.'

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