Healthcare Industry News: Aradigm
News Release - January 5, 2006
Aradigm Files Request for Orphan Drug Designation for Inhaled Liposomal Ciprofloxacin for Cystic FibrosisHAYWARD, CA--(Healthcare Sales & Marketing Network)--Jan 5, 2006 -- Aradigm Corporation (NasdaqNM:ARDMD ) today announced that it has filed a request for orphan drug designation with the United States Food and Drug Administration (FDA) for its liposomal ciprofloxacin product for the management of cystic fibrosis (CF).
Orphan drug status may be granted to drugs that treat rare life-threatening diseases that affect less than 200,000 persons in the United States. Such designation provides a company with seven years of marketing exclusivity for a selected drug approved by the FDA along with regulatory assistance, reduced filing fees and possible tax credits.
The clinical program will investigate the pulmonary delivery of the novel formulation of this widely used anti-infective for its local and prolonged effects in the treatment of bacterial infections in CF. Aradigm's liposomal formulation is designed to change the short-acting nature of ciprofloxacin so that it becomes long-acting and remains in the lung for a sufficient amount of time to treat pseudomonas infections commonly found in patients with CF.
Aradigm recently hosted a meeting of leading CF medical experts to discuss the use of liposomal ciprofloxacin in this patient population. These thought leaders expressed an opinion that this innovative therapeutic product could meet an important unmet medical need as an additional antibiotic to treat respiratory infections in CF.
"We believe that liposomal ciprofloxacin could play an important role in improving the quality of life of patients with cystic fibrosis," said Babatunde Otulana, M.D., Vice President of Clinical and Regulatory Affairs at Aradigm. "Aradigm will advance this program through development and utilize the financial and regulatory benefits that orphan drug status provides."
CF is a genetic disease affecting roughly 30,000 children and adults in the United States and roughly 60,000 worldwide. This 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 the United States.
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.
Source: Aradigm Corp
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