MerLion Announces Initiation of a Phase III Clinical Programme to Evaluate Finafloxacin for the Treatment of Acute Otitis Media

Singapore, 18th April, 2012 – MerLion Pharmaceuticals Pte Ltd (MerLion) announces the start of the first Phase III clinical trial to evaluate finafloxacin for treating infections of the ear.

The first development indication for topical finafloxacin will be for the treatment of acute otitis externa (outer ear and ear canal). The two Phase III trials planned for this indication are randomised, double-blind, vehicle-controlled studies involving up to 1,000 patients in 120 study sites in the United States and Canada.

Dr. Tony Buss, CEO of MerLion, commented, “Today’s announcement of the first Phase III clinical trials to be conducted with finafloxacin represents an important step in developing the compound for use as a highly differentiated, broad spectrum antiinfective. We anticipate announcing further clinical developments of both intravenous and oral formulations of finafloxacin in the near future.”

About Finafloxacin Finafloxacin is a novel, highly differentiated fluoroquinolone antibiotic with a unique pH activation profile. The antibacterial activity of finafloxacin increases significantly at pH values below neutral i.e., under infection relevant conditions. The compound exhibits an all inclusive spectrum of activity that covers Gram positive, Gram negative, anaerobic and atypical pathogens. In addition to otic and ophthalmic indications, finafloxacin, which has already shown potential for the treatment of a range of infections in Phase IIa clinical studies, is being evaluated in critical care and hospital based infection settings.

For more information visit MerLion’s website

About Ear infections

Outer ear infections, referred to as otitis externa, are common bacterial infections. Although the presence of bacteria in the outer ear canal is normal and healthy, it can develop into infection when the right conditions are present for it to thrive. Such conditions include when skin in the ear canal is injured or damaged, often from objects like cotton swabs, or when water gets trapped in the ear from activities like swimming. The infection creates swelling, which is often painful. Middle ear infections can develop as a result of colds or flu, when bacteria move into the middle
ear from the nose or throat.

About MerLion Pharmaceuticals

MerLion Pharmaceuticals Pte Ltd is a privately held company headquartered in Singapore with clinical development operations based in Berlin, Germany. The company is organised into two key business units; MerLion Research and MerLion Development.

MerLion is supported by a group of leading global investors including Aravis, Bio*One Capital (a subsidiary of EDBI), HeidelbergCapital and Nomura Research & Advisory.

For more information visit MerLion’s website

MerLion Contact: Tony Buss, PhD, President and CEO +65 6829 5600 Email: