The United States Patent and Trademark Office has issued US Patent No. 8,071,127 regarding formulations of inhaled liposomal and free ciprofloxacin to Aradigm Corporation. The patent covers the company’s lead candidate, Pulmaquin dual release ciprofloxacin for inhalation, and should provide exclusivity for the product until October 22, 2027. Aradigm now plans to take Pulmaquin, which contains a mixture liposomal ciprofloxacin with unencapsulated ciprofloxacin, into Phase 3 trials.
Aradigm President and CEO Igor Gonda commented, “We are very pleased with the performance of Pulmaquin in our preclinical tests and, most importantly, with its safety and efficacy record in humans to date, including the 168-day Phase 2b clinical trial (ORBIT-2) in non-cystic fibrosis bronchiectasis patients colonized with Pseudomonas aeruginosa. The issuance of the first US patent covering combination formulations of encapsulated and unencapsulated ciprofloxacin significantly strengthens the intellectual property estate around Pulmaquin and represents a valuable asset for Aradigm. We are continuing to secure and expand our proprietary position for Pulmaquin in the United States, and we have filed patent applications in other important territories.”
The company also announced that its IND filings for Lipoquin inhaled liposomal ciprofloxacin for the treatment of non-cystic fibrosis bronchiectasis and for cystic fibrosis have been inactivated.
Read the Aradigm press release.
