• Transaction enables Nicox to leverage OTC-directed asset from Aciex acquisition, while focusing resources on its ophthalmic pipeline assets targeting major prescription markets

  • Nicox to receive payment on approval and a share of future revenue from sales of AC-120

  • Ora to finance all development activities

  • Upcoming Phase 2/3 in morning eyelid swelling or ‘puffiness’

Sophia Antipolis, France and Andover, Massachusetts

Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, and Ora, Inc., the world’s leading ophthalmic clinical research and product development firm, today announced that Nicox’s subsidiary Nicox Ophthalmics, Inc. and Ora entered into a license agreement granting Ora exclusive worldwide rights for the development and commercialization of Nicox’s AC-120, an innovative drug-candidate for morning eyelid swelling.

Under the terms of the exclusive license agreement announced today, Ora will be responsible for all development activities and will fund this program through its investment arm. Ora plans to advance the clinical development of AC-120 and to subsequently sub-license this compound to a third party for future commercialization. Nicox is eligible to receive a $10 million milestone payment from Ora upon approval of AC-120 by the U.S. Food and Drug Administration (FDA). Nicox is also eligible to receive a percentage of any proceeds received by Ora under a potential sub-license agreement.

Gavin Spencer, Executive Vice-President Corporate Development of Nicox, said: “AC-120 is an OTC-directed asset of the pipeline acquired with Aciex Therapeutics, which holds significant potential in the treatment of the common condition of morning eyelid swelling. Our decision to out-license it is consistent with our corporate strategy to pursue a focused development pipeline of promising prescription drug candidates targeting major ophthalmic indications. We believe Ora is the perfect partner to further develop this compound, based on their experience and ability to define the clinical-regulatory pathway and identify the best commercial partner thanks to its extensive relationships in the industry. We are delighted that they will provide the means to take this project forward while we focus our resources on our internal pipeline, as announced in December 2015 following the strategic review of our European commercial business.

Stuart B. Abelson, President and CEO of Ora, Inc., said: “Morning eyelid swelling is a prevalent unmet condition and represents a significant cash-pay market opportunity. Our prior positive experience developing AC-120 and other Nicox/Aciex candidates gives us a view on the development, conviction in the long-term potential of AC-120, and we are eager to continue the development of this compound in Phase 2/3 testing.

AC-120 is an eye drop that targets morning eyelid swelling (also known as ‘puffy eyes’), a common complaint of aging individuals, particularly women, and a condition with a range of different causes. In a Phase 2 clinical program conducted by Aciex and Ora, treatment with AC-120 led to a reduction in morning eyelid swelling with results that showed statistical significance. AC-120 was also well tolerated, with no adverse effects noted.

Nicox acquired AC 120 in October 2014 as part of the acquisition of Aciex Therapeutics, Inc., which was since renamed Nicox Ophthalmics, Inc. Under the terms of the acquisition of Aciex, Nicox could pay up to $10 million in Nicox shares to Aciex’s former shareholders if AC-120 is approved by the FDA (see Nicox press release dated July 2, 2014).