Cystic fibrosis (CF) is a genetic disease that afflicts children and adults, causing their bodies to produce a thick mucus that can clog airways and result in chronic lung infections. Chiron’s TOBI is the only inhaled antibiotic approved by the FDA for treating CF patients with lung infections caused by the Pseudomonas aeruginosa bacterium. Because it is delivered directly to the lungs, the drug can be given at higher, more effective doses than would be safe if administered systemically. Clinical studies have shown that TOBI significantly improves lung function, reduces the frequency and length of hospital stays, and decreases the use of IV antibiotics. Chiron successfully launched TOBI in major European markets in 2001, while increasing its use among U.S. patients.
As a pivotal part of Chiron’s strategy to grow its TOBI franchise by enhancing ease-of-use, the company is collaborating with Inhale Therapeutic Systems to develop a dry-powder TOBI product and delivery system. Expected to enter clinical trials in 2002, this second-generation product should expand the use of TOBI by improving compliance and encouraging treatment earlier in the course of a patient’s disease. Chiron and Inhale also plan to explore the development of other inhaled antibiotics using Inhale’s Inhance™ pulmonary delivery platform.
Chiron is investigating additional indications for TOBI, including bronchiectasis, a chronic, destructive lung disease affecting 70,000 to 100,000 patients in the U.S. A Phase II clinical study will be initiated in 2002. The company is also leveraging its small molecule research expertise to develop a strong pipeline of antibiotic candidates, including PA-1806, a novel gram-negative antibiotic for pseudomonal lung infections currently in Phase II testing, and PA-2794, a broad-spectrum preclinical candidate.
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