Healthcare Industry News: ciprofloxacin
News Release - January 16, 2007
Aradigm Receives FDA Orphan Drug Designation for Liposomal Ciprofloxacin for BronchiectasisHAYWARD, Calif.--(HSMN NewsFeed)--Aradigm Corporation (OTCBB:ARDM ) today announced it has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for an inhaled liposomal formulation of ciprofloxacin for the management of bronchiectasis (BE). Aradigm previously received orphan drug designation for the same formulation of ciprofloxacin for the management of cystic fibrosis in April 2006.
Aradigm's liposomal ciprofloxacin is an aerosolized formulation of this proven anti-infective drug that was designed to prolong its anti-infective properties in the lung in order to treat the related infections found in BE and cystic fibrosis patients, while minimizing the concentration of the drug in the rest of the body.
"We are very pleased with the orphan drug designation for an additional indication for our inhaled liposomal ciprofloxacin formulation. The orphan drug designation continues to support our strategy to help patients with severe respiratory disease," said Babatunde Otulana, M.D., Senior Vice President of Development at Aradigm.
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 an 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 drug is currently in the preclinical stage of development. The designation also provides the opportunity to obtain market exclusivity for seven years from the date of NDA approval.
BE is a chronic necrotizing infection of the bronchi and bronchioles leading to or associated with abnormal dilatation of the airways. It is a relatively rare condition, affecting about 110,000 people in the United Sates, and results from a cycle of inflammation, recurrent infection, and bronchial-wall damage. Most patients require recurrent or chronic antibiotic treatment to suppress the lung infection, which is often due to Pseudomonas or other bacteria.
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, inhalation anthrax infections and smoking cessation.
In addition, Aradigm's AERx insulin Diabetes Management System (iDMS), which has been licensed to Novo Nordisk for development and commercialization in return for royalties, is in Phase 3 testing for Type 1 and Type 2 diabetes. Under the agreements with Novo Nordisk, Novo Nordisk is responsible for all further clinical, manufacturing and commercial development, while Aradigm and Novo Nordisk continue to cooperate and share in technology development, as well as intellectual property development and defense. Novo Nordisk also remains a substantial shareholder and investor in Aradigm. 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 and AERx are registered trademarks of Aradigm.
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