Company history
Business Development
Drug Development
2000
Company founded as biotech start-up Combinature Biopharm AG
2004
In-licensing of friulimicin, a novel lipopeptide antibiotic
2004
Begin of the preclinical, clinical and manufacturing activities for friulimicin
2006
In-licensing of finafloxacin, a 5th generation fluoroquinolone antibiotic
Company merger with MerLion Pharmaceuticals, Singapore
2006
Begin of the preclinical, clinical and manufacturing activities for finafloxacin
2007
Initiation of the first clinical phase I study with friulimicin
Initiation of the first clinical phase I study with finafloxacin
2009
Investigational New Drug (IND) approval by the US Food and Drug Administration (FDA) for finafloxacin
2010
License agreement with Alcon (an affiliate company of Novartis) for the development and commercialization of finafloxacin for the treatment of otic (ear) infections
2010
Initiation of the first clinical phase I study with intravenous dosing of finafloxacin
2012
Start of two clinical phase III trials with finafloxacin for the treatment of acute otitis externa (by Alcon/Novartis)
Start of a clinical phase II trial with finafloxacin for the treatment of complicated urinary tract infections (cUTIs) and pyelonephritis
2013
Finafloxacin granted qualified infectious disease product (QIDP) designation and fast track status under the Generating Antibiotic Incentives Now (GAIN) act by the US FDA
2014
XtoroTM (finafloxacin suspension) granted market approval by the US FDA for the treatment of acute otitis externa (AOE; "swimmer's ear")
2016
XtoroTM granted market approval by Health Canada for the treatment of AOE
2017
US Defense Threat Reduction Agency (DTRA) grant awarded to MerLion and the UK Defence Science and Technology Laboratory (Dstl) to explore the use of finafloxacin against potential biothreat pathogens
2018
License for the otic use of finafloxacin (XtoroTM) returned to MerLion due to a strategic re-orientation at Alcon/Novartis
2020
Company split-up, establishing MerLion Pharmaceuticals, Germany, as an independant corporation