RandyW Posted May 3, 2008 Share Posted May 3, 2008 Aradigm Announces Data Showing No Occurrence of Primary Lung Cancer in Patients Treated with AERx® Insulin Diabetes Management System (iDMS) Preclinical and Clinical Data Supports Lung Safety of AERx® iDMS HAYWARD, Calif.--(BUSINESS WIRE)--Aradigm Corporation (OTCBB:ARDM) (the “Company”) today announced that review of the clinical data by Novo Nordisk a/s (“Novo Nordisk”), with whom the Company had a collaboration for inhaled insulin, revealed no occurrence of primary lung cancer in patients inhaling insulin using the AERx® insulin Diabetes Management System (iDMS). AERx iDMS uses an aqueous formulation of insulin delivered by a hand-held electronic inhaler. Review of the clinical trial data for AERx iDMS revealed no cases of primary lung cancer either in the 2,307 patients treated with AERx iDMS or in the 1,218 patients treated with comparator treatments. Additionally, no treatment-related histological changes were seen in the lungs of rats following a 6-month exposure period or in monkeys exposed for a 9-month period. Furthermore, quantitative evaluation of proliferating cells in the lungs of the animals in these studies revealed no difference in proliferation between the treatment and control groups. Such cell proliferation assays are used to assess the potential for abnormal cell growth, which may be a precursor for lung cancer. Based on the Company’s analysis of market data from Business Insights and Wolters Kluwer PHAST, the Company believes that the market for inhaled treatments of chronic respiratory diseases is estimated at approximately $20 billion and growing at over 10% per year. “Treatments of respiratory diseases by inhalation have proven to be valuable to millions of patients with asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis,” said Igor Gonda, Ph.D., the Company’s President and CEO. “Aradigm remains strongly committed to development of a pipeline of inhalation therapies to help patients with severe respiratory diseases.” Novo Nordisk previously announced the termination of its phase 3 clinical trials for fast-acting inhaled insulin delivered via AERx iDMS. Novo Nordisk stated they were not terminating the trials because of any safety concerns. The latest review by Novo Nordisk was in response to an announcement made by Pfizer Inc. (“Pfizer”) on April 24, 2008 that it has updated the product labeling for Exubera(a), a diabetes treatment inhaler that delivers dry powder formulations containing insulin as the active ingredient, to include a warning about lung cancer cases observed in patients who received Exubera in its clinical program. Pfizer reported that in the clinical trials, 6 out of 4,740 patients using Exubera developed lung cancer compared to 1 out of 4,292 patients in the control arm. The labeling update by Pfizer further stated that all patients who developed lung cancer had a prior history of cigarette smoking, and that there were too few cases to determine whether the development of lung cancer is related to the use of Exubera. About Aradigm Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of a portfolio of drugs delivered by inhalation for the treatment of severe respiratory diseases by pulmonologists. Current activities include partnered and self-initiated development programs addressing the treatment of cystic fibrosis, bronchiectasis, pulmonary hypertension, asthma and bronchitis, inhalation anthrax infections and smoking cessation. More information about Aradigm can be found at www.aradigm.com. Forward-Looking Statements Except for the historical information contained herein, this news release contains forward-looking statements that involve risk and uncertainties, including the development of certain products and the safety of the AERx insulin Diabetes Management System (iDMS). These and other risks are detailed in Aradigm Corporation's Securities and Exchange Commission (SEC) Filings, including Aradigm's Annual Report on Form 10-K, and quarterly reports on Form 10-Q. Aradigm and AERx are registered trademarks and the Aradigm Logo is a trademark of Aradigm Corporation. (a)Other names and brands may be claimed as the property of others. Quote Link to comment Share on other sites More sharing options...
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