Potential Market

Potential Market

The respiratory therapy market has a clear need for new and effective drugs for the treatment of COPD and asthma. This market is in excess of $34 billion annually worldwide and BioMarck's technology has strong potentials for multiple therapeutic applications. The BioMarck technology will address a variety of pulmonary diseases, including COPD, asthma and chronic rhinitis, and possibly sinusitis and cystic fibrosis. Individually, each of these market segments represents strong growth potential. The worldwide sales of COPD therapeutics were over $20 billion in 2009 with asthma representing a further $12 billion. In 2010 almost 8% of the population suffered from serious respiratory disease. This equates to over 55 million people in the major markets of USA, Europe and Japan. In the USA alone there are 13.5 million COPD patients, where it is the 3rd leading cause of death, claiming over 130,000 lives per year.

There are currently 12 pharmaceutical companies marketing more than 25 different prescription drugs for asthma and COPD. Almost all the marketed drugs are beta-agonists, steroids, or combination drugs. There have been recent approvals of asthma drugs in combination with steroids for the treatment of COPD, but these do not offer real innovation in treatment and most have significant side-effect issues. Patent life for many of these currently marketed drugs is nearing completion. Moreover, none of the marketed drugs exhibit the BIO-11006 mode of action of directly inhibiting mucus hypersecretion AND reducing inflammation. It is well recognized that this means that these drugs cannot reverse the progression of the disease.

BIO-11006, being a dual inhibitor of mucus over-secretion and inflammation, provides a unique and novel approach for the treatment of many respiratory diseases. There has been no innovative new drug introduced into this market in more than 30 years. New targets are currently being investigated, but some have adverse characteristics not exhibited by BIO-11006, as well as a very narrow therapeutic window.

Notwithstanding the fact that several companies are developing products for respiratory diseases, BIO-11006 has a unique mode of action, giving it significant first-in-class? benefits. The currently marketed drugs for COPD and asthma would likely be additive or synergistic to BIO-11006.