Nicox S.A., a new international player in the ophthalmic market, has signed an agreement to acquire all of the outstanding equity of Aciex Therapeutics, Inc., a private, US-based, ophthalmic development pharmaceutical company with a strong near-term pipeline of therapeutics addressing major segments of the ophthalmic market, including allergy and inflammation. The acquisition will significantly broaden and strengthen Nicox’s therapeutic development pipeline, which would include two phase 3 candidates (latanoprostene bunod, currently being developed by Nicox’s partner Bausch + Lomb, and Aciex’s AC-170 for allergic conjunctivitis).

In addition, the proposed acquisition brings other therapeutic candidates which could enter clinical studies within 12 to 18 months and a collaborative research agreement on preclinical Syk/JAK inhibitors. The completion of the acquisition remains subject to the approval of Nicox’s shareholders and other customary conditions.

Aciex’s therapeutic pipeline includes:  AC-170 for allergic conjunctivitis, which has completed two phase 3 trials and for which Nicox plans to seek a pre-NDA meeting before the submission of a New Drug Application (NDA);     AC-155, in development for post-operative inflammation and pain, which is expected to enter phase 2 studies in 2015; A collaborative research agreement with Portola Pharmaceuticals, Inc. for small molecule dual Syk/JAK inhibitors for potential topical ophthalmic treatments;  A portfolio of clinical and pre-clinical product candidates targeting areas including ocular allergy, dry eye and other inflammatory eye conditions, and  A proprietary manufacturing process that can be used to repurpose existing drugs by producing novel, patentable nanocrystalline forms.

Michele Garufi, chairman and chief executive officer of Nicox, said: “This proposed acquisition is another significant step forward in Nicox’s strategy of creating an international ophthalmic company built around therapeutics and diagnostics with its own commercial infrastructure in the United States and in the major European markets. The combination with Aciex would enable Nicox to expand its therapeutic pipeline to target major segments of the ophthalmic sector, including the $816 million US allergic conjunctivitis market1. Together with the expansion of our diagnostics franchise, this acquisition further enhances our ability to create a unique company with a transatlantic commercial presence as well as a diversified proprietary product portfolio.”

Les Kaplan, executive chairman of Aciex, and Thomas Cavanagh, president of Aciex, added: “We are excited about the opportunity to combine our robust pipeline derived from our collaboration with Ora, Inc., with the financial and commercial strengths of Nicox. With a portfolio of programs now either in or approaching the clinic, we believe that this transaction will accelerate their development and commercialization. We look forward to working with the Nicox team to ensure the success of the expanded business.”

Under the proposed acquisition, Nicox will acquire all outstanding shares of Aciex on a cash-free debt-free basis through a reverse triangular merger, governed by US laws and regulations. Aciex shareholders will receive an upfront payment of $65 million entirely in the form of 20,627,024 newly issued Nicox shares, plus contingent value rights (CVRs) giving right to Nicox shares based on the potential US FDA approval(s) of AC-170 and of two additional undisclosed products within a pre-determined period. These CVRs are defined as follows: $35 million for the US approval of AC 170 on or before the earlier of 18 months after the date of filing of an NDA with the FDA or December 1, 2016; or $10 million if the approval is granted after this date, but on or before the earlier of 30 months after the date of filing of an NDA with the FDA or December 1, 2017; and $10 million each for the following two US product approvals by July 1, 202. These could potentially bring the total consideration to a maximum of $120 million. In general, and subject to certain negotiated exceptions, the Nicox shares issued to Aciex stockholders will be subject to lock-up restrictions.

MTS Securities, LLC, an affiliate of MTS Health Partners L.P., is serving as the exclusive financial advisor to Nicox in this transaction. Mintz Levin Cohn Ferris Glovsky and Popeo, P.C. is serving as US legal counsel to Nicox and Clifford Chance Europe LLP is serving as French legal counsel to Nicox. Aquilo Partners, L.P. acted as the exclusive financial advisor to Aciex in this transaction, and WilmerHale is serving as the legal advisor to Aciex.

Nicox is a new international player in the ophthalmic market building a diversified portfolio of innovative therapies and diagnostic tools addressing the needs of eyecare practitioners and patients around the world.