Debiopharm receives FDA Fast Track designation for anti-infectious agent Debio 1450

Debiopharm Group^™ (Debiopharm), a Swiss-based global biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) granted Fast Track designation to its anti-infectious agent Debio 1450, a highly potent antibiotic specifically active against all Staphylococcus species. FDA Fast Track designation facilitates the development and expedites review of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Debio 1450 has also received designation as a Qualified Infectious Disease Product (QIDP) in September 2014 for the same indication.

Debio 1450 exhibits a unique selectivity for staphylococcal species, it is expected to prevent development of multiple drug resistant organisms like VRE (vancomycin resistant enterococci) and to reduce antibiotic-associated side effects. "The growing resistance to antibiotics poses a major global threat to public health. Studies estimate that drug-resistant infections result in at least 25,000 deaths in 29 countries in Europe and 23,000 deaths in the U.S. every year" said Jean-Maurice Dumont, Vice President, Medical Affairs. "Fast Track designation will surely speed up patients' access to Debio 1450 by accelerating its entry on the market and provide a new option for physicians to treat patients with serious bacterial skin infections."