APC-1000 is a hydrofluoroalkane (HFA) branded generic inhaled oral steroid for the treatment of asthma and COPD. For APC-1000, Adamis is using a well-known and well-accepted steroid and combining it with an HFA propellant to make this a pulmonary metered dose inhaler (pMDI) with global potential. The Company believes that product development risks for this product are low, since this product has been well accepted and the clinical trial path to approval is well documented.
Our partner, Beximco, has demonstrated the know-how and ability to manufacture complex HFA products-overcoming the barriers to entry that have made it difficult for generic firms to develop such products. Beximco currently manufactures and sells an APC-1000 like product for developing countries.
Problems ranging from poor compatibility of surfactants with HFA, to difficulties associated with sealant technologies, to significant modifications to the manufacturing facilities have all contributed to creating barriers to entry, and at the same time, present a unique opportunity for Adamis.
Addressable Market ~ $3.0 billion
Asthma is a chronic lung disease that inflames and narrows the airways. Asthma causes recurring periods of wheezing, chest tightness, shortness of breath, and coughing. Asthma affects people of all ages, but it most often starts during childhood. In the United States, more than 25 million people are known to have asthma and about 7 million of these people are children.
Chronic obstructive pulmonary disease, or COPD, is a progressive disease that makes it difficult to breathe. COPD can cause coughing that produces large amounts of mucus, wheezing, shortness of breath, chest tightness, and other symptoms. Cigarette smoking is the leading cause of COPD. Long term exposure to other irritants- such as air pollution, chemical fumes, or dust - also may contribute to COPD.