Healthcare Industry News: lung infection
News Release - May 9, 2006
Aradigm Receives FDA Orphan Drug Designation of Liposomal Ciprofloxacin for Cystic FibrosisHAYWARD, CA--(Healthcare Sales & Marketing Network)--May 9, 2006 -- Aradigm Corporation (NasdaqSC:ARDM ) today announced it has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for a proprietary liposomal formulation of ciprofloxacin for the management of cystic fibrosis.
Aradigm's liposomal ciprofloxacin is an aerosolized formulation of this proven anti-infective drug that was designed to increase the drug's residence time in the lung and prolong its anti-infective properties in order to treat the related infections found in these patients.
"This designation for liposomal ciprofloxacin provides us the opportunity to help accelerate our efforts behind this innovative product," said Babatunde Otulana, M.D., Senior Vice President of Clinical and Regulatory Affairs at Aradigm. "We appreciate the multiple financial and strategic benefits that this status provides us in developing this application for an area of unmet medical need."
Orphan drug designation is intended to encourage research and development of new therapies for diseases that affect fewer than 200,000 patients in the United States. As a designated orphan drug, liposomal ciprofloxacin is eligible for tax credits based upon its clinical development costs, as well as assistance from the FDA in guiding the drug through the regulatory approval process. The designation also provides the opportunity to obtain market exclusivity for seven years from the date of NDA approval.
CF is a genetic disease affecting approximately 30,000 children and adults in the United States and about 60,000 worldwide. The defective gene causes production of excess mucus that clogs the lungs and often leaves patients vulnerable to life threatening lung infections. CF is the most common fatal genetic disease in Caucasians.
Aradigm combines its non-invasive delivery systems with novel formulations to create products that enable patients to comfortably self-administer biopharmaceuticals and small molecule drugs. The company's advanced AERx® pulmonary and Intraject® needle-free delivery technologies offer rapid delivery solutions for liquid drug formulations. Current development programs and priorities focus on the development of specific products, including partnered and self-initiated programs in the areas of respiratory conditions, neurological disorders, heart disorders, smoking cessation, and diabetes. More information about Aradigm can be found at www.aradigm.com.
Except for the historical information contained herein, this news release contains forward-looking statements that involve risk and uncertainties, including clinical results, the timely availability and acceptance of new products, the impact of competitive products and pricing, the availability of funding from partners or capital markets, and the management of growth, as well as the other risks detailed from time to time in Aradigm Corporation's Securities and Exchange Commission (SEC) Filings, including the company's Annual Report on Form 10-K, and quarterly reports on Form 10-Q.
Aradigm, AERx and Intraject are registered trademarks of Aradigm.
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