AstraZeneca asked SkyePharma to design a new inhaler for its big-selling asthma drug in December 2001, mindful of new legislation that demands that all inhalers move away from CFC propellants. The so-called Montreal Protocol banned the use of CFCs in products in 1995, but medical inhales have enjoyed a transition period owing to the complexities of gaining approval for new propellants.
The new Pulmicort metered-dose aerosol inhaler uses a hydrofluoroalkane propellant instead, which has been shown to offer the same accuracy and consistent delivery as the current Pulmicort inhaler, SkyePharma said. The replacement of CFC propellants with HFAs can lead to substantial differences in MDI performance.
Under the terms of agreements signed in December 2001, SkyePharma is responsible for all preclinical 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 the product in Europe and other non-US territories.
AstraZeneca is responsible for the commercial supply of the product and has recently appointed Inyx 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 reports to AstraZeneca, expected in the autumn. This is part of the total milestone payments of up to $12 million due to SkyePharma under this agreement. In addition, the UK firm will receive royalties on net sales of the product.
Last year, Italy's Chiesi Farmaceutici was granted approval in Germany for a CFC-free inhaler used to deliver budesonide for asthma. At the time, the Budiair product was the first formulation of budesonide formulated using a HFA propellant to be approved for marketing in the European Union. Chiesi's HFA- based Modulite inhaler lies at the core of the product.