Asthma affects over 300 million patients worldwide. Total asthma market in developed countries (US, Europe and Japan) was valued at $ 34 billion in 2010.. Inhalation drugs contribute 70% of this market

Inhaled short and long-acting beta agonists and corticosteroids are fundamental to the treatment of asthma. Dry Powder Inhalers (DPIs) containing long-acting beta agonists and inhaled corticosteroids constitute largest drug class with sales of US$ 10.4 billion* and market share of 54%.

SPARC’s DPI device offers a premetered 60 dose device that is activated by inhalation. Our device is small, convenient and easy to carry. Our device is easy to use across pediatric, geriatric, and adult patient populations. The device delivers uniform dose independent of breathing flow rate. What is more, the device is designed to avoid double dosing.

Our device is specially designed in such a manner that it delivers the drug at 50% of the dose of the branded product and still offers the same efficacy. Our product has demonstrated comparable efficacy to Seretide Diskus in a 113 patients Phase III clinical trial in India.

Certain features have been added that make it user friendly- there is a visual, audible and tactile feedback upon dose administration. A glow-in-the-dark feature ensures easy night-time use. There is a feature for assisting visually impaired, as reminder to refill device, when 8 doses remain.

In head on trials versus the innovator device, SPARC’s DPI demonstrated statistically and clinically significant improvement from the base line on all efficacy parameters studied. There was also a reduction in use of rescue medication, by day and night time asthma symptoms.

Phase III studies in India have been completed with this device and the product is likely to be launched in the domestic market, in the first half of 2011.

For the US, we are using the 505 b(2) route, a pre IND meeting has been completed with the USFDA and the initial response seems to be positive. An IND is now likely to be filed..