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18th April 2006

Cambridge Consultants' and Chiesi Farmaceutici's innovative dry powder inhaler nears release

A new dry powder inhaler, NEXT™, whose aim is to help improve the treatment of asthma and COPD (chronic obstructive pulmonary disease) through greater user appeal and more efficient and consistent drug delivery, is to be presented for the first time at the Respiratory Drug Delivery (RDD) conference in Florida on April 23 - 27 2006.

The NEXT™ DPI, designed by Cambridge Consultants and Chiesi Farmaceutici, consistently achieves a high fine particle fraction (>50% with a range of formulations) and has successfully completed pharmacokinetic clinical studies. The device, currently being ramped up for manufacture, has also finished extensive user-group research where both doctors and patients reacted positively to the DPI's features, which include a reliable dose counter, a simple user-interface and a discreet and robust, yet modern, style. The device looks well positioned to capture significant market share as it delivers the critical benefits required by healthcare professionals and patients.

NEXT™ is a medium resistance, breath-activated device which holds up to 120 doses and is one of a new generation of bulk reservoir DPIs. The device is intuitive to use - simply open, inhale and close - and has excellent dose uniformity. The concept was selected according to criteria that were identified as desirable for an ideal device in market research: portable, robust, intuitive and provides feedback to let the patients understand that the dose has been correctly taken, guaranteeing an accurate and consistent dose delivery. In the same market research, in focus groups, the NEXTTM™ DPI obtained the consensus of those interviewed that it represents the device of the future. The combination of ease-of-use, high-performance, consistency and reliability clearly benefits both patients and doctors.

Asthma is one of the world's most prevalent diseases, affecting between 100 million and 150 million people, according to the World Health Organisation (WHO). In the UK, the NHS spends over £850 million treating the disease, yet 1,400 people die on average each year, of which 90% of cases are preventable (based on statistics from Asthma UK). In the US, the American Lung Association claims that the disease affects over 20 million people, costs the country over $11.5 billion annually and results in the death of over 5,000 people every year. The WHO ranks COPD as the fourth leading cause of death worldwide, a position it shares with HIV/AIDS.

"The results that we have received so far from clinical trials and user groups have been truly impressive," said Gaetano Brambilla, R&D Project Leader at Chiesi. "The combination of our innovative drug formulations and Cambridge Consultants' design expertise has resulted in a device that we expect to be very competitive towards the established market leaders."

Dr David Ellis of Cambridge Consultants added, "We started from scratch, creating new concepts for the NEXT™ device and through close collaboration with Chiesi we developed a substantially improved device, both in terms of performance and user appeal. The entire development team is delighted with the results and this device should have a positive impact on the lives of millions of asthma and COPD sufferers."

Chiesi will be releasing device-specific data at the Respiratory Drug Delivery conference, which will be held at the Boca Raton Resort and Club in Florida from April 23 to April 27. Both Cambridge Consultants and Chiesi will be exhibiting at the Technology Exhibition from April 24 to 25.

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