An Antibiotic with Both Orphan Drug and Qualified Infectious Disease Product Designations
Arrevus Inc., a biotechnology company developing novel therapeutics for orphan diseases, today announced that it has completed the acquisition of fusidic acid from Melinta Therapeutics. Arrevus is now better positioned to advance its pipeline into clinical use for patients with serious bacterial infections where there is substantial unmet need.
Melinta Therapeutics is a commercial-stage company dedicated to developing and commercializing novel antibiotics to treat serious bacterial infections and currently has four FDA-approved antibiotics.
On December 20th, 2018, Arrevus agreed to purchase fusidic acid, an antibiotic with more than 50 years clinical experience outside the United States that had been acquired by Melinta in a merger transaction with Cempra Pharmaceuticals and was under development by Cempra for the treatment of ABSSSI and refractory bone and joint infections. Fusidic acid is orally active against gram-positive bacteria, including methicillin-resistant Staphylococcus aureus strains.
Want to publish your own articles on DistilINFO Publications?
Send us an email, we will get in touch with you.
Cempra successfully completed a phase 3 clinical trial in patients with ABSSSI demonstrating a tolerability profile and efficacy comparable to linezolid. Further data presented at IDWeek 2018 showed that 60% of patients with refractory bone and joint infection were clinical successes after 6 months of oral fusidic acid treatment. Fusidic acid received Orphan Drug Designation from the FDA for the treatment of prosthetic joint infection and also received Qualified Infectious Disease Product Designation under the Generating Antibiotic Incentives Now Act.
“There is only one member of the fusidane class of antibiotics; fusidic acid. Arrevus is excited to expand the available infectious disease treatment options to patients in the United States by continuing the development of fusidic acid for the US market,” commented Dr. Carl Kraus, Chief Executive Officer of Arrevus.
Date: February 11, 2019
Source: Arrevus
