The Centers for Disease Control and Prevention (“CDC”) estimates that 20.3 million U.S. residents have some type of asthma or asthma-like illness, and 33 million have been diagnosed with a form of asthma during their lives. The estimated nationwide prevalence of chronic bronchitis and emphysema is 16 million people. Of this group, an estimated 14 million cases were due to chronic bronchitis and 2 million from emphysema.
In light of this data, it can be conservatively estimated that the United States pulmonary disease market totals 30+ million people. Additionally, Consumer Reports and The New York Times reported that there has been an increase in asthma by 30% to 40% over the past decade. The current treatment of choice for asthma, bronchitis, and emphysema is inhaled steroids. The estimated cost for one week of such treatment is $16-$20 per patient.
In addition to the U.S. market, there is a significant worldwide need for an effective non-toxic pulmonary disease drug. The combined populations of Europe, Japan, Canada and the United States equal 1.135 billion people. Of this population group, 5%, or 56.75 million people suffer from asthma and related lung diseases.
EmphyCorp has the proprietary technology to penetrate this market and secure a major market share. EmphyCorp will target the U.S. market first and then the worldwide markets by entering into sublicense agreements and/or joint ventures or outright sale with respiratory drug manufacturers or companies seeking to enter the respiratory drug market, both in the U.S. and foreign countries.
The FDA has determined that N115 has sufficient safety toxicology and clinical data to proceed with the multi-dose, extended use, clinical trials. Phase II studies will focus on asthmatics and COPD patients. On the basis of existing clinical data, EmphyCorp is confident that its Investigative New Drug, N115, can and will be used for maintenance or continuous treatment of patients over extended periods of time. The Company believes that N115 will set the standard in the pharmaceutical industry for the treatment of major pulmonary diseases.