Ligand’s Partner Melinta Therapeutics Announces U.S. FDA Approval of Baxdela™ (Delafloxacin) for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Business Wire: June 20, 2017 – SAN DIEGO, CA, U.S.A. – Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces that partner Melinta Therapeutics, a privately held company focused on discovering, developing, and commercializing novel antibiotics to treat serious bacterial infections, announced yesterday that the U.S. Food and Drug Administration (FDA) has approved Baxdela™ (delafloxacin), indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. Baxdela is a fluoroquinolone that exhibits activity against both gram-positive and gram-negative pathogens, including MRSA (methicillin-resistant Staphylococcus aureus), and is available in both intravenous (IV) and oral formulations. Baxdela IV utilizes Ligand’s Captisol® technology. As a result of the approval, Ligand has earned a $1.5 million milestone payment and will earn a 2.5% royalty on Baxdela IV sales.
“We congratulate Melinta for this first regulatory approval for Baxdela,” said John Higgins, chief executive officer of Ligand. “Melinta has been an excellent partner, efficiently managing their clinical development work and collaboratively interfacing with Ligand’s technical team in successfully leveraging our Captisol technology for the IV formulation of Baxdela. We have identified this program as one of Ligand’s Big Six partnered pipeline assets given its medical importance and stage of development. This approval and Melinta’s recently announced commercial and co-development agreement with Menarini Group position Baxdela for global commercial success.”
“The approximately 3 million patients hospitalized each year in the United States with ABSSSI often present treatment challenges owing to their underlying medical conditions, making optimal antibiotic selection difficult. Baxdela provides a treatment option for adult patients with ABSSSI based on its coverage spectrum, IV and oral dosing flexibility, efficacy, and safety profile,” said Eugene Sun, M.D., CEO of Melinta. “The approval of Baxdela demonstrates FDA’s commitment to making new and effective antibiotics available to address unmet needs for hospitalized ABSSSI patients.”
“Antibiotic resistance is a growing concern, and physicians need more tools in the fight against this threat to modern medicine. Approval of new therapies like Baxdela, which is effective against MRSA and other serious pathogens, provides physicians another option in addressing the challenges of ABSSSI patients,” said Dr. David Hooper, professor of medicine, Harvard University, and chief of infection control, associate chief, Division of Infectious Diseases, Massachusetts General Hospital.
The Baxdela New Drug Application (NDA) approvals were supported by two phase 3 studies in patients with ABSSSI, demonstrating that IV and oral Baxdela monotherapy was statistically non-inferior to the combination of vancomycin plus aztreonam at the FDA primary endpoint of early clinical response at 48–72 hours. Baxdela was well tolerated with a 0.9% discontinuation rate in the phase 3 studies due to adverse events. In addition, Baxdela has not shown any potential for QT prolongation or phototoxicity in definitive clinical studies. There have been no signals of adverse effects on liver function, kidney function, or glucose regulation in controlled clinical studies. The 450 mg tablet is bioequivalent (area under the curve) to, and interchangeable with the 300 mg IV dose, and can be dosed without regard to food. There are no anticipated drug-drug interactions with delafloxacin other than co-administration with chelating agents, such as antacids.
Baxdela (delafloxacin) tablets and intravenous injection are approved for the treatment of ABSSSI (acute bacterial skin and skin structure infections). Baxdela was given priority review by the FDA due to its designation as a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act of 2012. The QIDP designation qualifies Baxdela for certain incentives related to the development of new antibiotics, including a five-year extension of any non-patent exclusivity period awarded to the drug.
