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New asthma device moves closer to Europe

By Kirsty Barnes , 26-Apr-2006

Bespak is now ramping up manufacturing of Chiesi Farmaceutici's new dry powder inhaler (DPI), in preparation for clinical trials of the device in patients with asthma and COPD (chronic obstructive pulmonary disease).

The new DPI, called Next, is the first of a new generation of bulk reservoir DPIs and is a fairly compact, breath-activated device, measuring 7cm x 5cm x 2cm and holding up to 120 doses.

Next, designed by UK's Cambridge Consultants and Italy's Chiesi Farmaceutici, will fill a gap in the asthma/COPD market for a device that is portable, robust, easy to use, and provides feedback to let patients know that the dose has been correctly taken, guaranteeing a more accurate and consistent dose delivery, said the company.

The device looks well positioned to capture significant market share as it delivers the critical benefits required by healthcare professionals and patients, the company added.

In the UK, the National Health Service (NHS) spends over £850m (€588m) treating asthma, yet 1,400 people die on average each year, of which 90 per cent of cases are preventable.

Next will initially be aimed at the European market and UK specialty device contract manufacturer Bespak is now ramping up production to supply Phase III clinical trials planned for the end of the year, Gaetano Brambilla, R&D Project Leader, told In-PharmaTechnologist.com.

Bespak is the same company that has been charged with the job of making the insulin delivery device for Pfizer's new hopeful blockbuster, Exubera.

However, Chiesi believes that its device won't be plagued by the same reimbursement issues that Exubera is currently facing in the UK.

"In our market we will be competing against other inhaler devices and our product will be price competitive with these devices," said Brambilla.

"Exubera is a new route of administration in the insulin market, with no other similar competitors as yet and so the device is being sold at a premium price," he said.

The product has recently completed Phase II pharmacokinetic clinical studies and consistently achieved 60 per cent fine particle fraction (FPF), said the company.

"There are a range of other devices on the market or reported to be in development with varying FPF characteristics, however, performance characteristics such as FPF will depend not just on the device but also the formulation in the device," said Dr David Ellis of Cambridge Consultants.

"Our device is better than most other devices currently available, although I have not seen the data on competing products still in the pipeline," said Ellis.

AstraZeneca's Turbohaler has an FPF of 10 - 25 per cent; GSK's Diskus/Accuhaler has an FPF of approx 20 - 40 per cent; while Sanofi Aventis's Eclipse has an FPF of 50 - 70 per cent.

Other competing devices still in development include Ventaira's new inhalation device and formulation of a steroid for asthma/COPD, called Mystic, planned to begin Phase II trials in the US.

Vectura has also recently announced that it has agreed a worldwide collaboration, development and licence agreement with German giant Boehringer Ingelheim, to develop a non-reservoir DPI for asthma and COPD.

Regardless of which product will emerge triumphant, the hive of activity in this field will ensure that asthma and COPD sufferers can soon breathe a sigh of relief.

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