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US Patent Protection for Pulmaquin Is Extended with Issuance of a Composition of Matter Patent


Tuesday, February 21, 2012

Hayward, CA -- Aradigm Corporation ("Aradigm" or the "Company") today announced that the United States Patent and Trademark Office has issued an important composition of matter patent (U.S. Patent No. 8,119,156) covering formulations of liposomal and free ciprofloxacin, including its lead preparation, Pulmaquin (Dual Release Ciprofloxacin for Inhalation, DRCFI, ARD-3150). The Company expects that the patent will provide exclusivity for Pulmaquin until October 22, 2028.

"The issuance of this composition of matter patent covering combination formulations of encapsulated and unencapsulated ciprofloxacin significantly strengthens the intellectual property estate around Pulmaquin and represents a valuable asset for Aradigm," said Igor Gonda, PhD, Aradigm's president and chief executive officer. "This is the second issued US patent to cover Pulmaquin. On December 7, 2011, Aradigm announced the issuance of a method of treatment patent (U.S. Patent No. 8,071,127). We are continuing to secure and expand our proprietary position for Pulmaquin in the United States, and we have filed patent applications with similar language in other territories.

"Pulmaquin has the potential to become an important treatment for bronchiectasis and cystic fibrosis patients with Pseudomonas lung infections, and other patients with lung infections. Pulmaquin has been tested extensively in preclinical tests as well as in the ORBIT-2 Phase 2b bronchiectasis study in which we found outstanding antimicrobial activity coupled with good safety and tolerability and, most importantly, a positive impact on prevention of pulmonary exacerbations compared to placebo. We look forward to moving to Phase 3 with a strategic partner as soon as possible."

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 (CFI, ARD-3100) is a liposomal formulation of ciprofloxacin. Pulmaquin is a dual release formulation (DRCFI, ARD-3150) that is a mixture of Lipoquin with unencapsulated ciprofloxacin. In addition to the Phase 2b study (ORBIT-2) with Pulmaquin, the Company previously reported positive results from a Phase 2b study with once daily inhaled Lipoquin (ORBIT-1) in BE patients, and from Phase 2a studies in CF and BE patients. The Company has also been 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 liposomal ciprofloxacin and for inhaled ciprofloxacin for BE in the U.S.

About Bronchiectasis

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.

About Aradigm

Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization 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.

Forward-Looking Statements

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 future clinical trials and treatment effectiveness of the Company's formulations, 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, 2010 filed with the SEC on March 25, 2011, and the Company's Quarterly Reports on Form 10-Q.

Aradigm and the Aradigm Logo are registered trademarks of Aradigm Corporation.



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