FDA Grants QIDP Designation to Aradigm’s Inhaled Antibiotic Pulmaquin designated as a QIDP for Treatment of Non-Cystic Fibrosis Bronchiectasis Patients with Chronic Lung Infections with Pseudomonas aeruginosa Business Wire HAYWARD, Calif. -- May 20, 2014 Aradigm Corporation (OTC BB: ARDM.OB) (the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has designated the Company’s lead inhaled antibiotic candidate, Pulmaquin®, as a Qualified Infectious Disease Product (QIDP). The QIDP designation, granted for treatment of non-cystic fibrosis bronchiectasis (non-CF BE) patients with chronic lung infections with Pseudomonas aeruginosa, will make Pulmaquin eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now Act (GAIN Act). These incentives include priority review and eligibility for fast-track status. Further, if ultimately approved by the FDA, Pulmaquin is eligible for an additional five-year extension of Hatch-Waxman exclusivity. The Phase III clinical program for Pulmaquin in non-CF BE consists of two worldwide, double-blind, placebo-controlled pivotal trials (ORBIT-3 and ORBIT-4) that are identical in design except for a pharmacokinetics sub-study to be conducted in one of the trials. Each trial will enroll approximately 255 patients into a 48-week double blind period consisting of 6 cycles of 28 days on treatment with Pulmaquin or placebo plus 28 days off treatment, followed by a 28-day open label extension in which all participants will receive Pulmaquin (total treatment duration approximately one year). The superiority of Pulmaquin vs. placebo during the double blind period will be evaluated in terms of the time to first pulmonary exacerbation (primary endpoint), while key secondary endpoints include the reduction in the number of pulmonary exacerbations and improvements in the quality of life measures. Lung function will be monitored as a safety indicator. “We are very pleased that the FDA has granted QIDP designation to Pulmaquin,” said Igor Gonda, Chief Executive Officer of Aradigm Corporation. “Persistent lung infections with Pseudomonas aeruginosa are a key factor related to the poor quality of life and untimely death in non-cystic fibrosis bronchiectasis patients. The QIDP designation will accelerate the advancement of Pulmaquin development as a potential treatment for these patients.” About Aradigm’s inhaled ciprofloxacin formulation brand - Pulmaquin Ciprofloxacin, available in oral and intravenous formulations, is a widely prescribed antibiotic. It is used to treat acute and chronic lung infections and is often preferred because of its broad-spectrum antibacterial activity against various bacteria such as Pseudomonas aeruginosa. Pulmaquin is a dual release formulation that is a mixture of liposome encapsulated (Lipoquin®) and unencapsulated ciprofloxacin. It is being evaluated in two Phase III studies (ORBIT-3 and ORBIT-4) to determine its safety and effectiveness as a once-a-day inhaled formulation for the treatment of non-cystic fibrosis (CF) bronchiectasis. The ORBIT-3 study began dosing patients in April 2014 and ORBIT-4 will begin dosing patients in 1H 2014. Pulmaquin has been extensively tested through preclinical studies and a Phase IIb study (ORBIT-2). Previous studies have demonstrated no significant clinical safety concerns. Aradigm has been granted orphan drug designation for the combination of liposomal ciprofloxacin and free ciprofloxacin for non-CF bronchiectasis in the U.S. In 2013, Aradigm granted an exclusive, world-wide license for the Company’s inhaled liposomal ciprofloxacin product candidates for the indication of non-CF BE and other indications to Grifols S.A. More information on the terms of this license may be found in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013 filed with the SEC on March 13, 2014. About the GAIN Act The GAIN Act, Title VIII (Sections 801 through 806) of the FDA Safety and Innovation Act, seeks to provide pharmaceutical and biotechnology companies with incentives to develop new antibacterial and antifungal drugs for the treatment of life-threatening, infectious diseases caused by drug resistant pathogens. Qualifying pathogens are defined by the GAIN Act to include multi-drug resistant Gram-negative bacteria, including Pseudomonas, Acinetobacter, Klebsiella, and Escherichia coli species. It extends the length of time an approved drug is free from competition and clarifies the regulatory pathway for new antibiotics. About Bronchiectasis Bronchiectasis is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. Non-CF BE represents an unmet medical need with high morbidity and mortality that affects more than 110,000 people in the U.S. and over 200,000 people in Europe. There is currently no drug approved for the treatment of this condition. About Aradigm Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs delivered by inhalation for the prevention and treatment of severe respiratory diseases. Aradigm has product candidates addressing the treatment of non-CF BE, cystic fibrosis and prevention of respiratory and other diseases in tobacco smokers through smoking cessation. Aradigm is also developing Pulmaquin and a liposomal ciprofloxacin formulation as potential medications for the prevention and treatment of high threat and bioterrorism infections, such as inhaled tularemia, pneumonic plague, Q fever and inhaled anthrax. 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 whether Pulmaquin will benefit from the QIDP designation; whether Pulmaquin will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of Pulmaquin will warrant the submission of applications for marketing approval, and if so, whether Pulmaquin will receive approval from the U.S. FDA or equivalent foreign regulatory agencies where approval is sought, 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, 2013 filed with the SEC on March 13, 2014, and the Company’s Quarterly Reports on Form 10-Q. Aradigm, Pulmaquin and the Aradigm Logo are registered trademarks of Aradigm Corporation. Contact: Aradigm Corporation Nancy Pecota, 510-265-8800 Chief Financial Officer or LifeSci Advisors Andrew McDonald, 646-597-6987 Founding Partner
FDA Grants QIDP Designation to Aradigm’s Inhaled Antibiotic
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