Pharmaxis, a specialist pharmaceutical company involved in the research, development and commercialisation of therapeutic products for chronic respiratory and autoimmune diseases, said that a clinical trial application for Bronchitol to treat bronchiectasis has been accepted for evaluation by China's State Food and Drug Administration (SFDA). Preliminary market research indicates that the number of Chinese who suffer from bronchiectasis is more than double that in the rest of the world. Pharmaxis expects Bronchitol to be the first targeted medication for this patient group in over 20 years.
"China represents an outstanding opportunity for Pharmaxis," said Alan Robertson, CEO, Pharmaxis, "A number of leading Chinese respiratory physicians has indicated they wish to conduct bronchiectasis studies, and have confirmed there is a large unmet need for new treatments for bronchiectatic patients. The cost of conducting clinical trials in China is significantly less than in other parts of the world, and the results of the trials can be used to support additional marketing applications throughout Asia Pacific and the rest of the world.
Bronchitol is being developed as a daily therapy for people with the currently incurable lung condition bronchiectasis. Bronchitol is administered by inhalation to the patient's lungs. Bronchiectasis is a degenerative and chronic lung condition that makes breathing difficult because of excessive mucus build-up in the lungs. Pharmaxis has the only product in phase III clinical trials for bronchiectasis anywhere in the world. Pharmaxis' representative office in Shanghai was formally registered and approved this week by the State Administration for Industry and Commerce of the People's Republic of China.
Bronchitol is proposed for the management of chronic obstructive lung diseases including bronchiectasis, cystic fibrosis and chronic bronchitis. Bronchitol is a proprietary formulation of mannitol administered as a dry powder in a convenient hand-held inhaler. It is designed to hydrate the lungs, restore normal lung clearance mechanisms, and help patients clear mucus more effectively. Clinical studies have shown Bronchitol to be well tolerated, to improve quality of life, and to stimulate mucus hydration and clearance in people with bronchiectasis and cystic fibrosis.
Bronchiectasis is one of the chronic obstructive pulmonary diseases, or COPDs, and affects children and adults. It is often mistaken for asthma or pneumonia and misdiagnosis is common.