HAYWARD, Calif.--()--Aradigm Corporation (OTCBB: ARDM) ("Aradigm" or the “Company”) today announced that the United States Patent and Trademark Office has issued an important new composition of matter patent (U.S. Patent No. 8,268,347) to Aradigm for formulations of liposomal and free ciprofloxacin, including its lead compound Pulmaquin. This patent provides new coverage for Lipoquin and extends protection for Pulmaquin until February 11, 2031.
“Chronic pulmonary infections are a key cause of severe morbidity and mortality for millions of people around the world and they contribute greatly to healthcare costs. This new patent significantly extends the protection of our inhaled antibiotic treatments for the management of patients with some of the most severe forms of lung disease,” said Igor Gonda, Aradigm’s president and chief executive officer.
This is the third issued U.S. patent to cover Pulmaquin and the first to cover Lipoquin. On December 7, 2011, Aradigm announced the issuance of a method of treatment patent (U.S. Patent No. 8,071,127) and on February 21, 2012, the Company announced the issuance of a composition of matter patent (U.S. Patent No. 8,119,156) covering Pulmaquin.
About inhaled ciprofloxacin (Pulmaquin and Lipoquin)
Ciprofloxacin is a widely prescribed antibiotic to treat infections of the lung frequently experienced by cystic fibrosis (CF) and non-cystic fibrosis bronchiectasis (BE) patients. It is often preferred because of its broad-spectrum anti-bacterial action. The available oral and intravenous formulations of the drug are used to treat episodes of acute exacerbations of lung infections in CF patients. The Company’s once-a-day novel inhaled formulations of ciprofloxacin are encapsulated in liposomes, allowing for a sustained release of the drug within the lung and improving airway tolerability. The formulations are to be used for chronic maintenance therapy as they are expected to achieve higher antibiotic concentration at the site of infection and relatively low systemic antibiotic concentrations to minimize side-effects. Lipoquin is a liposomal formulation of ciprofloxacin. Pulmaquin is a dual release formulation that is a mixture of Lipoquin with unencapsulated ciprofloxacin. Pulmaquin has been tested extensively in preclinical tests, as well as in the ORBIT-2 Phase 2b bronchiectasis study in which outstanding antimicrobial activity coupled with good safety and tolerability was found, and, most importantly, the positive impact on prevention of exacerbations compared to placebo was also observed. The Company previously reported positive results in Phase 2a studies of 22 CF patients and 36 BE patients who received Lipoquin once-a-day for 2 (CF) or 4 (BE) weeks, respectively. Additionally, the Company is developing these formulations as a potential medication for the prevention and treatment of bioterrorism infections, such as inhaled anthrax and tularemia. Aradigm has been granted orphan drug designation for liposomal ciprofloxacin for cystic fibrosis in the U.S. and the E.U., and for the combination of liposomal ciprofloxacin and free ciprofloxacin for BE in the U.S.
Bronchiectasis is a chronic condition characterized by abnormal dilatation of the bronchi and bronchioles associated with chronic respiratory infections. It is frequently observed in patients with cystic fibrosis. It is a condition, however, that affects about 110,000 people without cystic fibrosis in the United States and many more in other countries, and results from a cycle of inflammation, recurrent infection, and bronchial wall damage. There is currently no drug specifically approved for the treatment of this condition in the U.S.
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. The Company has product candidates addressing the treatment of bronchiectasis, cystic fibrosis, inhalation tularemia and anthrax infections, and smoking cessation.
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 the timing and results of clinical trials and the extent of intellectual property protection, as well as the other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K for the year ended December 31, 2011 filed with the SEC on March 28, 2012, and the Company’s Quarterly Reports on Form 10-Q.
Aradigm, Pulmaquin, Lipoquin and the Aradigm Logo are registered trademarks of Aradigm Corporation.