Chiron Corporation has acquired exclusive worldwide development and commercial rights from Novartis for aerosolized cyclosporine (ACsA), a therapy under evaluation for treatment of acute rejections in lung transplant recipients. Financial terms of the agreement were not disclosed.
Chiron in-licensed ACsA based on data from a number of clinical studies in lung transplant patients, with about 100 lung transplant patients studied at the University of Pittsburgh. Chiron will review these data with regulatory authorities to determine their suitability as a basis for approval.
"ACsA represents an attractive opportunity for Chiron to leverage its commercial expertise with Tobi and its presence with pulmonary physicians in order to bring a valuable therapy to lung transplant patients," said Craig Wheeler, President, Chiron BioPharmaceuticals. "If approved, this compound could provide Chiron a potential near-term market opportunity that would be an excellent fit for our pulmonology sales force."
Tobi (tobramycin solution for inhalation) is Chiron's marketed product for the management of cystic fibrosis patients infected with Pseudomonas aeruginosa. (Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV1 less than 25 percent or greater than 75 percent predicted, or patients colonized with Burkholderia cepacia.) Cystic fibrosis is a leading cause of lung transplants, along with emphysema, pulmonary fibrosis and pulmonary hypertension.
There were approximately 1,400 lung transplants in the United States and Europe in 2001. Rejection occurs in about 80 percent of lung transplant patients within the first year, and there is a continuing need for new approaches to management.