Respiratory disease represents one of the most attractive pharmaceutical sectors, with sales expected to grow from the current $30 billion in 2004 to an estimated $65 billion in 2014. Asthma and chronic obstructive pulmonary disease (COPD) represent 40% and 16% of the respiratory market, respectively, and are the initial indications in development by Epigenesis. Allergic rhinitis represents 25% of the respiratory market, and Epigenesis is planning to target this indication in 2005. In 2004, the markets for these disease categories grew at an industry-leading rate of 20% over the prior year.

Our initial target disease, asthma, has been called a national epidemic and COPD is the fourth leading cause of death worldwide. It is estimated that 16 million Americans have COPD and an equal number are undiagnosed. Allergic rhinitis is also growing at alarming rates, especially in children. The need for a new generation of respiratory therapeutics is both great and growing.

Asthma is a chronic lung disease, which is characterized by inflammation of the air passages and results in the temporary narrowing of the airways that transport air to the lungs. Asthma is one of the United States' most common and costly illnesses, affecting over 17 million Americans and costing approximately $13 billion annually in direct and indirect expenditures. Asthma afflicts approximately 150 million people worldwide, and its prevalence, morbidity and mortality are increasing at rapid rates. Over 180,000 people died of asthma worldwide in 2004 (greater than 6,000 in the U.S.). Frequent visits/admissions for emergency care (over 2 million in the U.S. in 2002) demonstrate that currently available asthma drugs are insufficient to control the disease.
COPD is a leading cause of death and disability worldwide. It is largely preventable but expensive to treat. The World Bank estimates that COPD is responsible for > 29 million disability-adjusted life-years and 1 million years of life lost per annum around the world. These figures place COPD as the fifth most significant global health problem, and fourth leading cause of death. Furthermore, COPD is currently the twelfth leading cause of disability worldwide and is expected to be the fifth leading cause of disability by 2020.

COPD patients in the U.S. number approximately 13 million. The morbidity and mortality of this disease are accelerating not only in the U.S. but worldwide. Japanese and European rates of COPD are expected to continue to accelerate due to the irreversible lung damage caused by continued heavy use of tobacco products in these countries. The total cost of care for U.S. COPD patients has recently been calculated at $25 billion per year, based on a patient self-reported health utilization study.

Allergic Rhinitis, like asthma, has seen dramatic increases in incidence over the past decade. Rates of allergic rhinitis have increased worldwide from about 12% in the 1980s to about 25% today. The sales for allergic rhinitis drugs are expected to grow from the current $7 billion in 2004 to an estimated $15 billion in 2014. It is among the top ten chronic diseases in the U.S.

Other Target Diseases. Lung cancer is now the most frequently diagnosed major cancer in the world, and is also the most common cause of cancer deaths in males and females in the U.S. and worldwide. There are approximately 200,000 new cases of lung cancer diagnosed annually in the U.S. Each year, over 160,000 U.S. lung cancer patients die from their disease. The total annual cost of lung cancer in the U.S. exceeds $10 billion, 20% of all cancer care costs. An expanding market for lung cancer drugs is expected in Europe and Japan due to the expanding use of tobacco products in these countries. Japan, for example, has experienced a ten-fold increase in lung cancer rates since 1980s.