CSRT.L Regulatory News (CSRT)

2 Mar 2005 15:07

Bespak PLC02 March 2005 For immediate release 2 March 2005 Bespak plc Welcomes regulatory filing of Exubera in the United States Bespak plc (LSE: BPK), a leader in specialty medical devices, is pleased to notethat Pfizer Inc and Sanofi-Aventis announced today that the United States Foodand Drug Administration (FDA) has accepted for filing a new drug application forExubera(R) (inhaled human insulin powder). In conjunction with Nektar Therapeutics Inc, Bespak is developing themanufacturing process for the drug delivery device, which it will manufacture inits Milton Keynes facility. The timing of full-scale production is stilluncertain and will depend in part on the timing of the approval process. Pfizer and Sanofi-Aventis seek approval to market Exubera for adult patientswith type 1 and type 2 diabetes. Exubera is currently also under review by theEuropean Medicines Evaluation Agency. Exubera, a dry powder form of insulin that is inhaled into the lungs prior toeating using a specially designed inhalation device, has been studied in morethan 3500 patients, some for more than seven years. It is estimated that nearly 180 million people worldwide suffer from diabetes,and the number is expected to rise to 300 million people in the next 20 years.Currently, diabetes and its complications account for more than $100 billion inhealthcare costs annually in the United States. Mark Throdahl, Bespak's Chief Executive, said: "We are delighted that both theUS and European filings have been made and we look forward to participating inthe commercial success of Exubera by supplying the delivery device." For further information please call: Bespak plcMark Throdahl - Chief Executive +44 (0) 20 1908 552 600Martin Hopcroft - Group Finance Director Buchanan Communications +44 (0) 20 7466 5000Tim Thompson / Mark Court / Mary-Jane Johnson Notes for Editors: About Bespak plc Bespak, a specialty medical devices company, is at the forefront of developingnew delivery systems for the pharmaceutical industry. The company has a productrange covering metered dose inhalers, dry powder devices, actuators andcompliance aids. The company also develops and manufactures drug deliverydevices for leading global pharmaceutical companies. The group, which hasfacilities in King's Lynn and Milton Keynes in the UK and in Cary, NorthCarolina, in the USA. is a public company quoted on the Official list of theLondon Stock Exchange (LSE: BPK). For more information, please visitwww.bespak.com. This information is provided by RNS The company news service from the London Stock Exchange