ASTRAZENECA ANNOUNCES FIRST REGULATORY APPROVAL

AstraZeneca announced today the approval in Finland, as the first approval in the first European market, of a new pressurised metered-dose inhaler (pMDI) formulation of the inhaled corticosteroid Pulmicort® (budesonide) for the treatment of asthma in adults and children.

The currently available chlorofluorocarbon (CFC) pMDI formulation has been on the market since December 1981 and, in accordance with the Montreal Protocol, will be replaced by a non-ozone depleting formulation based on hydrofluoroalkanes (HFA). The new HFA pMDI has been developed by SkyePharma PLC, a UK drug delivery company, using its proprietary formulation technology. It will be available in two strengths, 100 µg and 200 µg. Further approvals in other EU and non-EU markets are in progress.

SkyePharma has been responsible for all product development aspects. The study programme comprises investigations of the new and the current formulation, as well as clinical studies in both children, adolescents and adults. A high dose safety evaluation is also included. The new formulation is in all respects clinically comparable to the old formulation.

Dr Dave Singh, Senior Lecturer at South Manchester University Hospitals Trust said: "As one of the principal investigators in the extensive clinical programme, I am happy to conclude that the new HFA based formulation has comparable clinical effects to the current CFC formulation, thus allowing clinicians to make a seemless transition to the new formulation. This new Pulmicort HFA pMDI secures continous use of one of the best documented inhaled steroids and thus provides an important treatment for many asthma patients."

Pulmicort (budesonide) is an inhaled corticosteroid indicated for maintenance treatment of asthma in children and adults. In some countries Pulmicort is also indicated for maintenance treatment of COPD. Pulmicort was first registered in 1981, is now approved in 89 countries and has been used for 12.5 billion treatment days. Pulmicort is available in three administration forms, a dry powder inhaler (Pulmicort Turbuhaler®), as a nebulising suspension (Pulmicort Respules®) and as a pressurized Metered-Dose inhaler (Pulmicort pMDI).