MerLion’s Antibiotic Receives US FDA Approval

FDA approval for the otic suspension of finafloxacin paves the way for future Phase III trials for the injectable and oral forms.

AsianScientist (Feb. 17, 2015) – Singapore’s MerLion Pharmaceuticals has received US Food and Drug Administration (FDA) approval for an otic suspension of their leading antibiotic candidate finafloxacin for the treatment of acute otitis externa, commonly known as “swimmer’s ear”. This marks the first time a Singaporean company has received FDA approval for a novel drug.

As the antibiotic resistance continues to develop at a worrying pace around the world, the search for new antibiotics has intensified. Although it belongs to an older class of antibiotics known as fluoroquinolones, MerLion’s finafloxacin has an excellent safety profile, allowing it to be administered at much higher doses and thereby reduce antibiotic resistance.

“Furthermore, because we can give a very high dose of the drug just once per day, finafloxacin is more convenient to administer. Most other antibiotics tend to be given two or even three times a day,” said Mr. David Dally, CEO of MerLion.

“The high maximum dose also means we can give patients a very short course of treatment. We’ve been able to show, for example, that a five day course of finafloxacin is as good as or even better than a ten day course of equivalent existing drugs.”

MerLion was spun off from the Center for Natural Product Research (CNPR), a joint venture between the Institute of Molecular and Cell Biology (IMCB) and Glaxo, in 2002. Finafloxacin was obtained via a merger with Combinature Biopharm AG and Athelas SA in 2006. Since then, their scientists have tested the activity of the drug against a range of bacteria and conducted pre-clinical trials.

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 IMCB over a decade ago. The company’s success with finafloxacin is a notable milestone in the development of Singapore’s biomedical sciences industry.”

Acknowledging the support, Dally added, “The Economic Development Board of Singapore’s (EDB) Bio*One Capital was a founding investor right from the start and has stayed with us. We are delighted to now have something to show for all the investment.”

MerLion has also recently concluded Phase II trial for both oral and injectable formulations of finafloxacin for the treatment of complicated urinary tract infections. The milestone payments received upon the current round of FDA approval, as well as the royalties once the drug is commercialized and available, will to towards funding the continued development of the oral and injectable forms.

“We will continue to test the oral and injectable forms in Phase III trials. Currently, we are in talks with various partners for funding for these intended trials,” Dally said.


Copyright: Asian Scientist Magazine; Photo: MerLion Pharmaceuticals.
Disclaimer: This article does not necessarily reflect the views of AsianScientist or its staff.

Rebecca did her PhD at the National University of Singapore where she studied how macrophages integrate multiple signals from the toll-like receptor system. She was formerly the editor-in-chief of Asian Scientist Magazine.

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