Filing of Exubera in US
March 02 2005 - 10:07AM
UK Regulatory
RNS Number:2560J
Bespak PLC
02 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 note
that Pfizer Inc and Sanofi-Aventis announced today that the United States Food
and Drug Administration (FDA) has accepted for filing a new drug application for
Exubera(R) (inhaled human insulin powder).
In conjunction with Nektar Therapeutics Inc, Bespak is developing the
manufacturing process for the drug delivery device, which it will manufacture in
its Milton Keynes facility. The timing of full-scale production is still
uncertain and will depend in part on the timing of the approval process.
Pfizer and Sanofi-Aventis seek approval to market Exubera for adult patients
with type 1 and type 2 diabetes. Exubera is currently also under review by the
European Medicines Evaluation Agency.
Exubera, a dry powder form of insulin that is inhaled into the lungs prior to
eating using a specially designed inhalation device, has been studied in more
than 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 in
healthcare costs annually in the United States.
Mark Throdahl, Bespak's Chief Executive, said: "We are delighted that both the
US and European filings have been made and we look forward to participating in
the commercial success of Exubera by supplying the delivery device."
For further information please call:
Bespak plc
Mark Throdahl - Chief Executive +44 (0) 20 1908 552 600
Martin Hopcroft - Group Finance Director
Buchanan Communications +44 (0) 20 7466 5000
Tim Thompson / Mark Court / Mary-Jane Johnson
Notes for Editors:
About Bespak plc
Bespak, a specialty medical devices company, is at the forefront of developing
new delivery systems for the pharmaceutical industry. The company has a product
range covering metered dose inhalers, dry powder devices, actuators and
compliance aids. The company also develops and manufactures drug delivery
devices for leading global pharmaceutical companies. The group, which has
facilities in King's Lynn and Milton Keynes in the UK and in Cary, North
Carolina, in the USA. is a public company quoted on the Official list of the
London Stock Exchange (LSE: BPK). For more information, please visit
www.bespak.com.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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