The agreement relates to the development and supply of Trudell's actuation indicator for use with the Italian firm's range of cholofluorocarbon (CFC)-free metered dose inhalers in the US and other markets.
There is no reliable method that exists today to indicate to patients the amount of drug left in their pressurised MDI systems, and this can have significant consequences in the treatment of asthma. According to a study conducted at the University of Michigan in 1995, this shortcoming "likely causes patients to extend the use of their meter-dose inhalers beyond the specified maximum number of actuations [and] this practice may well contribute to the documented rise in asthma morbidity and mortality."
In addition, the study found that as many as 54 per cent of patients were not aware of the maximum number of actuations in their canister and only 8 per cent of patients actually tracked the number of actuations used. This has led to calls for dose counters to be included as standard on pMDIs.
Trudell's actuation indicator can measure and record up to 300 actuations of an MDI. And integrated dose indicator can advise patients via a countdown mechanism or "fuel gauge" approach, and it can be integrated into any pMDI boot with some minor modifications to the product.
Chiesi has developed a CFC-free Modulite technology - which uses an ozone-sparing propellant called hydrofluoroalkane (HFA) - to produce new formulations of respiratory medications.
Three new products based on this technology have already been launched in Europe, including the Budiair (budesonide) inhaler which debuted in Germany last year.
The company is currently developing a new once-daily long-acting beta 2 agonist, as both a single entity and in combination with an inhaled corticosteroid, it said.
HFA is the prime substitute for the CFC gas propellant used in MDI sprays, by which approximately 95 per cent of all asthma medication is administered to the approximate 100 million people worldwide who suffer from asthma. CFC use in pharmaceutical products is already banned in Europe, Canada, Japan and many other countries.
The US is expected to start implementing the ban by 2006, but in 2003, 90 per cent of the asthma inhalers sold in the US contained CFC.