Market Overview

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


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

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".


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

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
, 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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