Novoclem Therapeutics Receives QIDP Status for Its Lead Inhaled Antimicrobial Drug Candidate

Novoclem Therapeutics, Inc., today announced that its lead inhaled antimicrobial drug candidate, BIOC51, has been designated as a “Qualified Infectious Disease Product” (QIDP) by the U.S. Food & Drug Administration. The QIDP designation, granted for treatment of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis, will make BIOC51 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, BIOC51 is eligible for an additional five-year extension of market exclusivity.