14th Oct 2005 12:49
Bespak PLC14 October 2005 For immediate release 14 October 2005 Bespak plc Welcomes Positive Opinion on Exubera(R) Bespak plc (LSE: BPK), a leader in specialty medical devices, is pleased to notethat Pfizer Inc announced yesterday that the Committee for Medicinal Productsfor Human Use (CHMP) of the European Medicines Evaluations Agency (EMEA) hasissued a positive opinion recommending the approval of Exubera(R) inhaleableinsulin for the treatment of type 1 and type 2 diabetes in adults. The proposed therapeutic indication for Exubera(R) is for the treatment of adultpatients with type 2 diabetes not adequately controlled with oral antidiabeticagents and requiring insulin therapy; and for the treatment of adult patientswith type 1 diabetes, in addition to long or intermediate acting subcutaneousinsulin, for whom the potential benefits of adding inhaled insulin outweigh thepotential safety concerns. Exubera(R), which is the product of a joint-development program between Pfizerand sanofi-aventis, is an inhaled rapidly acting insulin that is inhaled intothe lungs prior to eating, using a proprietary inhalation device and powderedinsulin formulation developed by Nektar Therapeutics. The product represents amajor advance in insulin delivery and will be the first non-injectable form ofinsulin available since the discovery of the drug in the 1920s. Bespak, in conjunction with Nektar, has developed the production process andwill manufacture the proprietary inhalation device for Exubera(R). Exubera(R) was filed with the US Food & Drug Administration (FDA) on 2nd March2005, and an FDA advisory committee recommended the approval of Exubera(R) on8th September for the treatment of adults with type 1 and 2 diabetes. Pfizerawaits the approval by the FDA in the US as well as approval by the EuropeanCommission. It is anticipated that once fully launched, Exubera(R) will be a significantsource of revenue growth for Bespak's Device & Manufacturing Services division. Mark Throdahl, Bespak's Chief Executive, said: "We are delighted by thisrecommendation from the CHMP, which moves us closer to European regulatoryapproval of this important new treatment for diabetes." 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, is a public companyquoted on the Official list of the London Stock Exchange (LSE: BPK). For moreinformation, please visit www.bespak.com. About diabetes 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. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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