Focus Group statement about DirectHaler™ Pulmonary device, from market research conducted in USA:

• “The device was thought to be an appropriate device for virtually any inhaled product that could be put into an appropriate powder form”.

Local and systemic delivery
DirectHaler™ Pulmonary has documented clinical performance for local delivery of beta2-agonists and cortico-steroids in asthma/COPD treatment. Further, the wide range of customization options for the device will enable a broad range of therapeutic applications including systemic delivery.

Each dose has its own single-use, disposable DirectHaler™ device. Therefore the device is ideally suited for following application types:

• “Once-daily” (e.g. Asthma, COPD, hormone replacement therapy)
• “Once-a-few-times” (e.g. respiratory infections, post-surgery pain)
• “Once-only” (e.g. vaccines) 
• Acute (e.g. Asthma, COPD, migraine, breakthrough pain)

The unique ease-of-use for the device, enables correct use of the device - from first use, also by inhaler naive patients. This is very important when considering "once-a-few-times" and "once-only" -applications both in prescription and OTC products.

Elaboration on Asthma and COPD applications
The present and future delivery tasks in asthma & COPD will increase and expand the requirements on the delivery technologies. DirectHaler™ Pulmonary opens a range of new options in choice of how to provide convenient inhaled delivery for best possible patient compliance.

Easy-to-use
for all asthma & COPD patient groups

Children will like the DirectHaler™. It can be carried conveniently Summer or Winter in any dress, and it is easy to use.

Young people will value DirectHaler™'s ease-of-use and discretion, as it eliminates those embarrassing moments young people worry about when using their asthma inhalers.

Adults will appreciate the ease-of-use and elegance of the DirectHaler™.

Elderly will find the use of DirectHaler™ simple, and therefore easy to learn and remember.

Easy-to-instruct and check
for GPs, asthma-specialists and pharmacies

Ease-of-use results in ease-to-instruct for the health care professionals. There is only a procedure for use of the inhaler. There is no dose loading and no cleaning of the device as it is single-use, disposable.

Compactly portable and “ready-to-use”
for acute asthma rescue medications

Acute asthma medications shall be available instantly to the patient - everywhere the patient goes.

DirectHaler™ is the first “multi-place” device concept:
Each dose is pre-filled its own device, so each unit is a complete dosing system. This allows for devices to be placed separately where the patient needs it: in your pocket, in your coat, in your car, at your desk at work, in your sports bag, in your suitcase etc.

Enhancing Patient Compliance
for daily asthma dosing

Compliance is key in asthma treatment. Unit dosing with DirectHaler™ places attention to each dose.

Dose counting is clear as each dose has its own Disposable device.

Device transparency ensures dose visibility: dose Ready and dose taken.

Instruction icons are printed in the back of the pharma blister pack. This ensures that instructions always available until the point of using the device.

New story to tell
for the sales representative

DirectHaler™ is unique, novel and offers a new reference for “ease-of-use” and hygienic performance. In any combination of a generic compound and DirectHaler™ Pulmonary, the inhaler will be the point of differentiation, which will add value to the overall product.

Enables to bring inhaled asthma therapy to all regions of the world
Offering the patient to buy only few doses at a time, will allow access to inhaled therapy - also in countries where few can afford to buy 100 or more doses at a time. The DirectHaler™ device provides also full instruction icons printed on the back of the pharma-blister foil, securing correct instructions also for patients with difficulty in reading medical texts.

Looking ahead in the treatment of asthma

A new and improved understanding of the relationship between asthma and rhinitis:

The relationships between rhinitis and asthma can be viewed under the concept that the 2 conditions are manifestations of one syndrome, the chronic allergic respiratory syndrome, in 2 parts of the respiratory tract.
At the low end of the syndrome's severity spectrum, rhinitis appears to be the sole manifestation, although pathologic abnormalities in the lower airways are already present.
At the higher end, rhinitis is worse, and the lower airways disease becomes clinically evident.
Once manifested, the 2 conditions track in parallel in terms of severity.
Togias A; Rhinitis and Asthma: Evidence for respiratory system integration. J Allergy Clin Immunol (United States), Jun 2003, 111(6) p1171-83.

The scientific foundation for “One Airway - One Disease” (from the ARIA research group) is based on more than 2500 references. Pioneer experiences from practise already show promise:

• Rhinitis treatment leads to reduction of asthma attacks in patients with both rhinitis and asthma.
• Rhinitis treatment reduces asthma symptoms, or prevents and postpones development of asthma.

The conclusion is:
A combined strategy should ideally be used to treat upper and lower airway diseases in terms of efficacy and safety.
Bousquet J, et al., Allergic rhinitis and its impact on Asthma
J Allergy Clin Immunology 2001 Nov; 108(5): S147-334.

The new Second-generation combination therapy
Asthma and rhinitis are complex diseases, where multiple pathways have to be modified simultaneously by locally (nasal and pulmonary) and systemically targeted drugs. Direct-Haler A/S has developed and applied for patent for second-generation respiratory combination therapy.

This innovation is a multiple-route combination drug concept (patent pending), for integrated delivery of a selected group of active substances by each active’s optimal delivery route. The therapeutic objectives are twofold:

1. Enable to postpone/prevent development of asthma by treating rhinitis symptoms + the underlying nasal inflammation + by reduction of bronchial hyper-responsiveness.
For this, the concept is based on a once daily, fixed combination of a nasal dose and an oral systemic dose.

2. Enable to reduce the risk of asthma attacks and hospitalisations by treating co-existing asthma and rhinitis for improved airway inflammation control and reduction of bronchial hyper-responsiveness.
For this, the concept is based on a once-daily fixed combination of a pulmonary dose, a nasal dose and an oral systemic dose.

The concept integrates proven (currently co-prescribed), golden-standard pharmaceutical ingredients, in dose combinations.

• Once-daily dosing formulations for enhanced compliance.
• The optimal delivery route for each active substance is applied, ensuring optimal efficacy, safety and dosing convenience.
• The second-generation combination therapy can be delivered by the DirectHaler™ drug delivery device systems.