Singapore, 11 February 2015 – MerLion Pharmaceuticals (MerLion), a biopharmaceutical company headquartered in Singapore with clinical development operations in Berlin, Germany, today announced that an otic suspension of finafloxacin has been approved by the FDA to treat acute otitis externa, commonly known as “swimmer’s ear”, caused by Pseudomonas aeruginosa and Staphylococcus aureus. Finafloxacin was licensed by MerLion to a major North American partner in 2010 for use in North America for otic (ear) infections.
MerLion retains the rights to intravenous and oral formulations of finafloxacin for all other indications and recently announced positive results from a phase 2 trial conducted in Europe treating around 200 patients hospitalized with complicated urinary tract infections. The results from this study demonstrated positive outcomes at all primary and all secondary endpoints; with patients treated once daily for five days with finafloxacin seeing higher, more rapid and sustained level of microbiological eradication and improved clinical outcomes compared to those treated with the current standard of care (ciprofloxacin taken twice daily for 10 days).
Mr. David Dally, CEO of MerLion, commented, “We are delighted to see that, following several years of the MerLion team working with our partner, the FDA has approved what we believe to be an excellent treatment for ear infections. This is especially pleasing since finafloxacin is the first novel drug from a Singapore company to achieve FDA approval.”
Ms. Chu Swee Yeok, CEO and President of EDBI said, “We are heartened to have played a pivotal role in MerLion’s journey since it was spun off from A*STAR’s Institute of Molecular and Cell Biology (IMCB) over a decade ago. The company’s success with finafloxacin is a notable milestone in the development of Singapore’s biomedical sciences industry.”