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24th October 2006

Four cent inhaler offers real alternative for pandemic vaccination

• Disposable inhaler will fundamentally change the way in which global vaccinations are administered
• New device delivers 40% more active drug than many current mass market inhalers

Cambridge Consultants today reveals details of a revolutionary new inhaler developed for mass vaccination against chronic diseases and global pandemics, such as avian flu. The new inhaler, called 'Conix One' delivers the performance expected of high-end inhalers at a lower cost than a syringe. In addition to these key performance and price achievements, the inhaler is extremely simple to use and is safe for front-line health workers.

This breakthrough product is expected to bring the ease and convenience of inhaled drug delivery to global scale initiatives where the key is to treat as many people as effectively, quickly and as economically as possible. To illustrate the scale of the potential issue, the World Health Organisation estimates that the number of deaths from a global avian flu pandemic could reach 7.4 million, whilst Datamonitor has estimated that the total cost of a global pandemic could total $800 billion.

Today, large-scale vaccinations are typically delivered via syringe, but for many chronic diseases inhalation offers the optimum delivery mechanism. Up until now though, the cost of producing an inhaler economically, and with the necessary performance, has not been possible. As well as exceeding both of these requirements, the inhaler is comfortable for the patient to administer and easy to use - the patient simply folds the device shut, inhales and then discards. This also eliminates the significant risk of needle stick injuries and infection, which in countries where diseases such as HIV are prevalent, poses a real threat to the lives and wellbeing of health workers.

"We believe that this inhaler will fundamentally change the way we treat many diseases on a global scale. Designed specifically with global pandemics, like H5N1, in mind, we have combined cutting edge technology with smart product design, enabling us to achieve something that has never been seen before," says Brian Barney, head of drug delivery at Cambridge Consultants. "It is akin to providing the performance of a sports car at a cost comparable with a moped. It is that significant."

The new inhaler is based around a novel 'reverse flow cyclone' and contains no moving parts or propellants - in fact the inhaler is made from a single piece of plastic and costs just four cents to manufacture in high volume (5M per annum). This ultra-low manufacturing cost is comparable with syringes, which cost between four and eight US cents, and is substantially cheaper than the asthma inhalers on the market today, which typically compose of around 20 parts and cost at least 40 cents in volume. Although manufacturing the new inhaler is similar in cost to that of the syringe, there are significant savings to be made as syringes are more expensive to distribute (drug in liquid form typically requires refrigeration) and they require skill and training to use. The Conix One inhaler uses a simple foil seal to protect the formulation from moisture and many patients can use their devices at the same time, making rollout far faster.

The unique swirling action within the patented cyclone provides an extremely effective deagglomeration process, enabling a large percentage of drug to be delivered efficiently into the lung. This action also overcomes the problem that many inhalers have, where the drug is released within just a fraction of a second - before the patient has had time to reach their optimal inhalation rate. The cyclone chamber releases a steady flow of drug over two seconds, enabling better use of a patient's lung power. A number of in-house tests with existing formulations from mass market asthma and COPD inhalers have shown that the drug separation mechanism is so efficient that it is up to 40% more effective than many inhalers on the market today.

"Currently, inhalers tend to be focused on specific treatments and are designed to typically contain between 14 and 200 doses. This suits conditions such as asthma, as the patient needs to use it three or four times per day, but when you only require a drug to be delivered once, the cost of current inhaler technology is prohibitive," adds Barney. "We are currently in active discussions with major pharmaceutical and medical device companies who have been universally astounded by the technology and what we have achieved."

Dr Val Perrin, an independent consultant in pharmaceutical medicine, who has seen the Conix technology first-hand, said: "The Conix inhaler is novel both in its overall design and simple mode of operation. This bodes well for its use in clinical trials and patient handling studies. Laboratory tests show that it also works well at low inspiratory flow rates, which will be additionally important for subjects such as the elderly and young children."

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