SkyePharma PLC and AstraZeneca announced the completion of phase III trials of a new version of AstraZeneca's Pulmicort (budesonide), an inhaled corticosteroid for the treatment of asthma, a release from SkyePharma said.

The Metered Dose aerosol Inhaler (MDI) uses a hydrofluoroalkane (HFA) propellant, replacing the chlorofluorocarbon (CFC) propellant used in the currently marketed MDI version of Pulmicort. CFCs are being withdrawn on environmental grounds because of their potential to damage the ozone layer. However the replacement of CFC propellants with HFAs can lead to substantial differences in MDI performance. Pulmicort HFA-MDI incorporates proprietary SkyePharma formulation technology to ensure accurate and consistent delivery that matches the release profile of the current version of Pulmicort MDI.

Under the terms of agreements signed in December 2001, SkyePharma is responsible for all pre-clinical and clinical development of Pulmicort HFA-MDI, as well as compiling regulatory filings for marketing approval in Europe. AstraZeneca will pursue filing of the marketing application and following approval will market Pulmicort HFA-MDI in Europe and other non-US territories. AstraZeneca is responsible for the commercial supply of the product and has recently appointed Inyx Inc as contract manufacturer responsible for scale-up activities and commercial production, initially for a three-year period.

A milestone will become payable to SkyePharma upon delivery of the final phase III clinical trial reports and stability reports to AstraZeneca, expected in the autumn. This is part of the total milestone payments of up to US$ 12 million due to SkyePharma under this agreement. In addition, SkyePharma will receive royalties on net sales of Pulmicort HFA-MDI, the release says.

Michael Ashton, CEO of SkyePharma, said, "We already have an established presence in the important and fast-growing pulmonary delivery market, with both breath-actuated dry-powder inhalers and metered-dose aerosol inhalers that use non-CFC propellants. The completion of the phase III trial of the HFA-MDI version of Pulmicort that we have developed for AstraZeneca is an important milestone towards eventual commercialisation and also towards validation of our MDI formulation technology."