MerLion Pharmaceuticals GmbH
MerLion Pharmaceuticals is a biopharmaceutical company focused on developing novel antibiotics to combat bacterial infections, including antibiotic-resistant bacteria. They develop drugs such as finafloxacin, which has shown safety and efficacy in clinical trials and is approved for certain indications like ear infections. The company is engaged in research, clinical development, and collaborations to bring effective treatments for serious bacterial infections and biothreats.
Industries
Nr. of Employees
small (1-50)
MerLion Pharmaceuticals GmbH
Robert-Rössle-Strasse 10, 13125 Berlin, Germany
Products
Topical finafloxacin otic suspension (market-authorized in US & Canada)
A topical suspension formulation of a fluoroquinolone antibiotic approved for treatment of acute otitis externa (outer ear infection).
Intravenous and oral systemic formulations (development-stage / clinical)
Intravenous solution and oral tablet formulations developed to provide systemic treatment options with demonstrated bioavailability and suitability for IV-to-oral switch regimens.
Topical finafloxacin otic suspension (market-authorized in US & Canada)
A topical suspension formulation of a fluoroquinolone antibiotic approved for treatment of acute otitis externa (outer ear infection).
Intravenous and oral systemic formulations (development-stage / clinical)
Intravenous solution and oral tablet formulations developed to provide systemic treatment options with demonstrated bioavailability and suitability for IV-to-oral switch regimens.
Services
Design and management of non-clinical and clinical development plans for antibacterial candidates, including execution of Phase I–III studies and associated PK/PD work.
Joint in vitro and in vivo research programs against biodefense-relevant bacterial pathogens in collaboration with defense laboratories and funders.
API and drug-product development, scale-up and production activities to enable market launch of approved formulations.
Partnering, licensing negotiations and commercialization planning for regional market authorization and distribution.
Design and management of non-clinical and clinical development plans for antibacterial candidates, including execution of Phase I–III studies and associated PK/PD work.
Joint in vitro and in vivo research programs against biodefense-relevant bacterial pathogens in collaboration with defense laboratories and funders.
API and drug-product development, scale-up and production activities to enable market launch of approved formulations.
Partnering, licensing negotiations and commercialization planning for regional market authorization and distribution.
Expertise Areas
- Antibacterial drug development
- Clinical trial management
- Formulation development (topical, oral, intravenous)
- Pharmacokinetics and pharmacodynamics (PK/PD)
Key Technologies
- In vitro MIC and susceptibility testing
- Biofilm activity assays
- Murine infection models (inhalational and systemic)
- PK/PD modeling and AUC/MIC bridging
News & Updates
MerLion reported a successful Type C meeting with the FDA regarding finafloxacin for melioidosis, indicating potential for licensure for this serious infection.
Published by the UK Defence Science and Technology Laboratory, this highlights finafloxacin's potential against biothreat pathogens such as plague and melioidosis.
In May 2021, MerLion announced the completion of a financing round to support the production and market launch of Xtoro™, an FDA-approved drug for ear infections.
A study showing finafloxacin's effectiveness against Burkholderia pseudomallei in animal models.
Finafloxacin demonstrates activity against CDC category A and B biothreat agents, including B. pseudomallei, F. tularensis, Y. pestis.
Animal studies indicating finafloxacin's high efficacy in protecting against inhalational melioidosis.
MerLion reported a successful Type C meeting with the FDA regarding finafloxacin for melioidosis, indicating potential for licensure for this serious infection.
Published by the UK Defence Science and Technology Laboratory, this highlights finafloxacin's potential against biothreat pathogens such as plague and melioidosis.
In May 2021, MerLion announced the completion of a financing round to support the production and market launch of Xtoro™, an FDA-approved drug for ear infections.
A study showing finafloxacin's effectiveness against Burkholderia pseudomallei in animal models.
Finafloxacin demonstrates activity against CDC category A and B biothreat agents, including B. pseudomallei, F. tularensis, Y. pestis.
Animal studies indicating finafloxacin's high efficacy in protecting against inhalational melioidosis.