Singapore’s first FDA approval for novel drug

MerLion Pharmaceuticals, a joint venture between the Institute of Molecular and Cell Biology (IMCB) and GlaxoSmithKline, received the first FDA approval for a novel drug amongst the outstanding biotechs based in Singapore. MerLion’s finafloxacin was acquired after its merger withCombinature Biopharm AG and Athelas SA in 2006, and is targeted for acute otitis externa (also known as “swimmer’s ear”).

Thanks to its well-trusted safety profile, the new antibody candidate can be administered at a high maximum dose. and hence allows a shorter interval/course of treatment and reduce the patients’ antibiotic resistance.  According to the CEO, Mr David Dally, “a five day course of finafloxacin is as good as or even better than a ten day course of equivalent existing drugs.”

Singapore’s government has been on the forefront of biotech industry support and investment. Ms. Chu Swee Yeok, CEO and President of EDBI (the corporate investment arm of the Economic Development Board Singapore (EDB)) added that, “the company’s success with finafloxacin is a notable milestone in the development of Singapore’s biomedical sciences industry.”

Apart from MerLion, Singapore is also home to many growing biotechs like LEO Pharma and ASLAN Pharmaceuticals.  The biopharma industry looks forward to greater competition within and growth in Singapore.

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