Raptor Pharma Announces QIDP Designation For MP-376 - Quick Facts

(RTTNews) - Raptor Pharmaceutical Corp. (RPTP) announced the U.S. FDA has granted Qualified Infectious Disease Product designation to MP-376, the company's inhaled levofloxacin, for three distinct indications: for the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa, in patients with cystic fibrosis and in patients with non-cystic fibrosis bronchiectasis, and in patients with nontuberculous mycobacteria. The QIDP designation provides priority review by the FDA, eligibility for Fast Track designation and a five-year extension of marketing exclusivity under the Hatch-Waxman Act.

The company expects to begin regulatory discussions with the FDA in cystic fibrosis in the second quarter and initiating a Phase 2 program in bronchiectasis in the year.