By Mitchell Young
New Haven: The FDA has approved Melinta Therapeutics' Baxdela (delafloxacin), a fluoroquinolone antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
The company was founded by three of Yale University's leading scientist-researchers in 2000 as RIBx. The company first began work on the drug when it licensed it in 2006 under the then CEO Susan Froshauer, now CEO of Connecticut United for Resource Excellence [CURE].
The FDA also provided Qualified Infectious Disease Product (QIDP)Status which provides for an additional five-year period of market exclusivity for the approved purpose.
A company release outlined the market opportunity for the drug in the US, saying, “approximately 3 million patients [are] hospitalized each year in the U.S. with ABSSSI.” The company added, ‘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.”
Kevin Ferro, CEO of Vatera Healthcare Partners, a New York based venture capital firm and Melinta’s largest investor said, “the FDA approval of Baxdela is a major milestone for Melinta. We are grateful to the patients, families, investigators and their staffs for their support in developing an important new therapy. We want to thank the Melinta team for its leadership in bringing the first of what we believe will be many innovative antibiotics to patients.”
Earlier the month the company reported positive results for another antibiotic to treat Gonorrhoea infections.
As previously reported last month, Melinta, a privately held company and the Menarini Group, a $3.5 billion in revenue Florence, Italy based, privately owned biopharmaceutical group, signed a development and commercialization agreement for the drug in anticipation of the approval [see As Drug awaits Approval...].
The Menarini Group purchased exclusive rights to commercialize Delafloxacin under their own brands in 68 countries in Europe, Asia-Pacific including China, South Korea, and Australia (Japan excluded), and the Commonwealth of Independent States (CIS) including Russia.
Melinta and Malin Plc of Dublin, Ireland, entered into similar agreement for certain countries in the Middle East and Africa as did Eurofarma Laboratórios of Sao Paulo, Brazil, one of the largest pharmaceutical companies in Brazil with the potential to expand into additional Latin American countries.
Melinta was originally founded as Rib-X in 2000 by a trio of Yale heavy weight researchers William L. Jorgensen, Ph.D., Peter Moore, Ph.D., Thomas A. Steitz, Ph.D. and Susan Froshauer, Ph.D. a then former Pfizer executive.
Froshauer was CEO of Rib-X until 2010, and when the company first acquired the rights to Delafloxaci, she is the current CEO of CURE [Connecticut United for Research Excellence], the biotech and pharmaceutical advocacy group.
Jorgensen is the Sterling Professor of Chemistry at Yale University. He was elected to the National Academy of Sciences in 2011.
Moore is the Sterling Professor of Chemistry, Emeritus, at Yale University. He was elected to the National Academy of Sciences in 1997.
Steitz is the Sterling Professor of Molecular Biophysics and Biochemistry and a Howard Hughes Medical Institute Investigator at Yale University. He was elected to the National Academy of Sciences in 1990. Steitz was awarded the Nobel Prize in Chemistry in 2009 for studies of the structure and function of the ribosome.