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. SPARC's DPI contains Salmeterol and fluticasone. 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.
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.
Our device is compliant with stringent US FDA and European requirements. This product is already approved and launched in India. For the US we are planning to file IND in Q3FY15. For Europe, we already have submitted the clinical trial application in Germany, and the study is planned to be initiated very shortly. For emerging markets, we have identified one emerging market for which we plan to submit our filing in Q1FY15.