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, announced that the U.S. Food and Drug Administration (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 United States. Fast Track status is intended to expedite drug development. Priority Review allows for an accelerated review of the marketing authorization, i.e. a six-month review compared to the standard 10-month 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 is currently in a dose-escalation Phase I study in healthy volunteers. It is one of the most advanced FabI inhibitors issued from the Debiopharm’s antibiotic technology platform “Fabiotics.” Debiopharm is very actively pursuing the development of new projects from this rich platform as seen in the recently launched Neisseria gonorrhea and enteric species programs.
“The threat of antibiotic resistance has become a reality and there is a real need for targeted molecules that preserve indigenous gut micro biota and overcome resistance to broad-spectrum antibiotics,” said Frederick Wattle, medical director, Debiopharm International SA.
“We are thrilled that the potential of Debio 1450 has been recognized with the FDA designation. It will clearly accelerate the development process and will give patients a quicker access to the drug,” added Thierry Mauvernay, delegate of the board of Debiopharm Group. “We are very confident that our powerful platform Fabiotics will continue to provide highly valuable targeted anti-infectives in the future in order to alleviate problems of acquired resistance linked to broad-spectrum antibiotic usage.”
Date: September 4, 2014
Source: Debiopharm Group