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Tobi (Tobramycin) Cuts In Half Hospitalizations For Young Cystic Fibrosis Patients With Asymptomatic Or Mild Lung Disease: Presented at CFC

EMERYVILLE, CA -- June 4, 2003 -- Chiron Corporation (Nasdaq: CHIR) today announced that it has presented the results of a Tobi® tobramycin solution for inhalation study at the 26^th European Cystic Fibrosis Conference in Belfast. The study, which involved 184 cystic fibrosis (CF) patients ages 6-15 years, showed that subjects undergoing Tobi treatment in conjunction with routine care were significantly less likely to be hospitalized for respiratory symptoms or to be treated with oral antibiotics than those undergoing routine care alone.

Tobi, for CF patients with chronic pseudomonal lung infection, is the cornerstone of Chiron's inhaled therapeutics franchise. In addition to the study results presented at the European Cystic Fibrosis Conference, Chiron has seen recent positive data on Tobi's efficacy in decreasing Pseudomonas aeruginosa (Pa) in pediatric patients as well as in treating chronic bronchiectasis, indicating a potential role for the drug in treatment of these diseases. Chiron is also evaluating data on aerosolized cyclosporine, which it recently acquired from Novartis, for the treatment of acute lung transplant rejection.

"Tobi has achieved strong penetration and compliance in the segment of CF patients with moderate and severe disease, and now we are seeing its value in earlier stages of the disease as well," said Craig Wheeler, president of Chiron's biopharmaceuticals business unit. "Chiron is dedicated to growing its strong pulmonology presence in order to benefit more patients."

Tobi Tobramycin Solution for Inhalation Study Results
Chiron sponsored an open-label, randomized, multicenter, controlled trial of Tobi treatment (300 milligrams of tobramycin solution for inhalation administered twice daily for one month on-drug, one month off-drug) in 184 subjects over 14 months, which revealed a significantly higher incidence of respiratory hospitalizations in the control group under routine care relative to subjects treated with Tobi in addition to routine care. In the control arm, 26 percent of subjects were hospitalized; in the treatment arm, 11 percent were hospitalized (p < 0.01). Adverse events seen in the treatment arm were consistent with previous studies of Tobi (hoarseness, cough, sore throat and tinnitus), were not severe and were transient. The study concluded that the use of Tobi in young CF patients infected with Pa and with mild lung disease appears to decrease the rate of hospitalization and concomitant antibiotic use and may slow the rate of spirometric decline.

Data published in the March 15, 2003, American Journal of Respiratory and Critical Care Medicine showed that Tobi had a significant microbiological effect in decreasing Pa in young children with CF. A double-blind, placebo-controlled, multicenter, randomized trial in 21 children under age 6 showed that Tobi treatment (300 milligrams of tobramycin solution for inhalation administered twice daily for 28 days) resulted in a profound decrease in Pa density from the lower airway of young children with CF. The trial was stopped early because the risk of additional bronchoscopies was deemed unacceptable in light of the evidence of a significant microbiological treatment effect -- Pa was eradicated in 8 of 8 Tobi-treated patients compared with 1 of 13 placebo patients (p < 0.001). No safety concerns were observed for Tobi in these young children based on adverse events, serum tobramycin concentrations, renal function, audiology testing, tobramycin MICs (minimal inhibitory concentrations) and lack of emergence of new pathogens. At the end of 2003, Chiron will initiate the ELITE (EarLy Intervention Tobi Eradication) trial in Europe to further study the benefits of Tobi in treatment of early onset Pa in CF patients.

Data from a recent study of Tobi in patients with bronchiectasis, a chronic pulmonary disease often complicated by complex gram-negative respiratory infection, were presented at the American Thoracic Society Meeting in Seattle in May. In an open-label, multicenter clinical trial, 41 subjects were treated with Tobi (300 milligrams of tobramycin solution for inhalation administered twice daily for three cycles of 14 days on-drug followed by 14 days off-drug) to evaluate pulmonary symptom scores, respiratory quality of life and microbiologic efficacy. As seen in a previous study, a minority of subjects (N=10) did not tolerate chronic Tobi and withdrew from the study due to adverse events characterized by cough, wheezing or dyspnea. Subjects completing the trial showed significantly improved pulmonary symptom scores (p < 0.001) and benefited from Tobi with respect to respiratory symptoms and quality of life.

About Cystic Fibrosis
Cystic fibrosis (CF) is a genetic disease that primarily affects people of Caucasian origin. About 30,000 people in the United States and about 70,000 people worldwide have CF. Patients with CF have abnormal movement of salt in and out of the cells lining their lungs, which leads to secretion of thick, sticky mucus that supports bacteria growth. Pseudomonas aeruginosa (Pa) is the most common bacterium causing lung infections in people with CF. By the age of 17, nearly 70 percent of people with CF have Pa in their lungs. Pa infections cause lung inflammation and -- through cycles of inflammation, obstruction and infection -- lead to deterioration of lung function, at an estimated average rate of 1.4 percent to 4 percent per year. Treatment of CF lung disease is aimed at controlling infection, reducing lung obstruction and decreasing inflammation.

About Tobi Tobramycin Solution for Inhalation
Tobi tobramycin solution for inhalation is an antibiotic approved in the United States and Europe for the treatment of cystic fibrosis (CF) patients with Pseudomonas aeruginosa, a bacterium frequently found in the lungs of these patients. Each ready-to-use ampule of Tobi contains 300 milligrams of tobramycin in a 5-milliliter solution. Tobi is inhaled twice daily, for about 15 minutes each time, in repeated cycles of 28 days on-drug, 28 days off-drug. The dose is the same for all patients regardless of weight, age or other factors. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in one second (FEV1) less than 25 percent or greater than 75 percent of predicted, or in patients colonized with Burkholderia cepacia. In controlled clinical trials, Tobi was well-tolerated, with voice alteration (13 percent versus 7 percent) and tinnitus (3 percent versus 0 percent) being the only adverse events reported by significantly more patients treated with Tobi than placebo. Patients with known or suspected renal, auditory, vestibulars or neuromuscular dysfunction should use caution when taking Tobi.

NOTE: Tobi is a trademark of Chiron Corporation.


SOURCE: Chiron Corporation

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