MerLion Regains North American Rights to XTOROTM FDA-Approved Antibiotic for Treatment of Ear Infections

SINGAPORE--(BUSINESS WIRE)-- MerLion Pharmaceuticals (MerLion), a pharmaceutical company focused on the advanced clinical development of its antibacterial drug finafloxacin, today announced that Novartis has made a portfolio decision and terminated the license between Alcon (a subsidiary of Novartis) and MerLion executed in 2010 and returned all rights to MerLion. MerLion now owns all rights to XTORO™ globally.

MerLion announced in 2015 that XTORO™, an otic suspension of finafloxacin, had been approved by the FDA for treatment of acute otitis externa, commonly known as “swimmer’s ear”, caused by Pseudomonas aeruginosa and Staphylococcus aureus.

Along with a cash payment, the settlement includes the assignment to MerLion of all of Alcon’s finafloxacin related patents and know-how, along with XTORO™ pharmaceutical product materials.

“Alcon has been a valuable development partner and we are grateful for its commitment to develop XTORO™ over the past years, leading to an FDA approval based on valuable clinical data, as well as generating new intellectual property” said David Dally, CEO of MerLion Pharmaceuticals. “MerLion is now well placed to progess the commercilization of XTORO™, either alone, or with partners”.

-ENDS-

About MerLion Pharmaceuticals

MerLion Pharmaceuticals Pte Ltd is a pharmaceutical company, headquartered in Singapore with R&D operations in Berlin, Germany, which is focused on the advanced clinical development of its antibacterial lead program, finafloxacin. MerLion is a privately held company supported by a group of leading global investors including Aravis Venture, Singapore based EDBI and Heidelberg Capital. For more information please visit www.merlionpharma.com

About Finafloxacin

Finafloxacin is a novel fluoroquinolone antibiotic with many “best in class” features. In clinical and pre-clinical settings the compound has shown a substantially improved therapeutic profile as compared to the existing gold standard and a broad utility in treating many severe infections, including those caused by resistant Gram-negative pathogens.

Finafloxacin’s superior profile arises from the compound’s unique mode of action, being equally active at physiological pH conditions and in the acidic environments which occur at the most sites of bacterial infections. Most other antibiotics, including other fluoroquinolones, show decreased activity under acidic tissue conditions, which results in a significant reduction of their overall efficacy.

As well as the liquid suspension formulation of XTORO™, MerLion has also developed intravenous and oral formulations of finafloxacin with equivalent bioavailability, which may offer physicians various options for in-hospital and out-patient treatment regimens. MerLion is exploring a number of options which could enable Phase III trials in cUTI to begin within 24 months.

The impact of finafloxacin for the treatment of infections caused by the biological intracellular threat agents Burkholderia pseudomallei, Francisella tularensis, Yersinia pestis and other multi-drug resistant (MDR) pathogens of clinical significance are currently being investigated in a joint project with the Defence Science and Technology Laboratory, UK (Dstl).

About Acute Otitis Externa

Acute otitis externa is an infection in the outer ear and ear canal, usually caused by bacteria in the ear canal. Activities in which the ear is underwater can create a moist environment where bacteria may sometimes grow. The infection causes inflammation of the ear canal leading to pain, swelling, redness of the ear and discharge from the ear.

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