Chiesi Farmaceutici announced that its HFA-based (Modulite) Budesonide pMDI formulation has been approved in Germany. This is the first approval of an HFA Budesonide within the European Union. The product will be launched in Germany as BUDIAIR at the beginning of this year. Marketing authorisation applications for Budesonide Modulite have been submitted in other European countries.

Budesonide pMDI was developed as a solution formulation with the proprietary technology platform Modulite based on the use of ozone-friendly HFA propellants. It allows the preparation of solution formulations whose key advantages are stability, dose delivery uniformity and flexibility in tailoring the particle size distribution of the cloud generated on actuation.

The principles of the technology have been powerfully exploited by designing an HFA-propelled system that closely matches the performance of the currently marketed budesonide CFC, thus allowing a seamless substitution of existing CFC products (same strength and dosage).

Exploiting its innovative Modulite technology, Chiesi has reformulated other two compounds: formoterol, now in phase III clinical trials, and beclomethasone dipropionate, launched in France, Italy, Greece and Germany. Beclomethasone Modulite was also licensed to GSK for some European countries. Other drugs, including new chemical entities, are currently under development both in pre-clinical and clinical stages. The development programme in Chiesi also includes the combination of a new once daily long-acting beta2 agonist (TA 2005) and a corticosteroid.