Debiopharm Group, a Swiss-based global biopharmaceutical company developing prescription drugs that target unmet medical needs including anti-infective and oncology therapeutics as well as companion diagnostics, has announced that the FDA has designated its anti-infectious agent Debio 1450 as a Qualified Infectious Disease Product (QIDP) for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
QIDP designation will give Debio 1450 access to Priority Review, Fast Track and five additional years of market exclusivity in the U.S. Fast Track status is intended to expedite drug development. Priority Review allows for an accelerated review of the marketing authorization (i.e. six months compared with the 10-month standard review).
These incentives were established as part of the GAIN Act (Generating Antibiotic Incentives Now), passed by the U.S. Congress in July 2012 to encourage pharmaceutical companies to develop new antimicrobials.
Debio 1450 (previously known as AFN-1720) is a highly potent oral/IV anti-infective agent that is specifically active against all Staphylococcus species, including all known resistant strains such as methicillin-resistant S. aureus (MRSA) and vancomycin-intermediate S. aureus (VISA). Debio 1450 currently is in a dose-escalation phase I study in healthy volunteers.
"The threat of antibiotic resistance has become a reality," said Frederick Wittke, medical director Debiopharm International, "and there is a real need for targeted molecules that preserve indigenous gut microbiota and overcome resistance to broad-spectrum antibiotics."