Nicox said today it agreed to acquire Aciex Therapeutics for up to $120 million, in a deal that the buyer said would help it advance its strategy of building a global company focused on eye therapeutics and diagnostics, with U.S. and European commercial operations.

Aciex will bring to Nicox a pipeline of ophthalmic therapeutic prospects, led by the Phase III drug candidate AC-170 for allergic conjunctivitis. AC-170 is a new formulation of cetirizine that has demonstrated statistically significant results in two phase III safety and efficacy studies over vehicle control for the primary endpoint of ocular itching. Nicox plans to seek a pre-NDA meeting on AC-170 by Q1 2015.

AC-170 becomes one of two Phase III candidates in the combined company’s pipeline; the other is latanoprostene bunod for the reduction of intraocular pressure in patients with glaucoma and ocular hypertension, currently being developed by Nicox partner Bausch + Lomb. Top-line phase III results are expected in Q4 2014, Nicox said.

Nicox said it was attracted to Aciex by its pipeline of allergy and inflammation products, among major segments of the opthalmic market.

The Aciex acquisition would expand Nicox’ pipeline with therapeutic candidates that could enter clinical studies within 12 to 18 months—including AC-155, a new nanocrystalline form of fluticasone in development for post-operative inflammation and pain that is expected to enter phase II studies in 2015—as well as:

  • A collaborative research agreement with Portola Pharmaceuticals, Inc. for small molecule dual Syk/JAK inhibitors for potential topical ophthalmic treatments;
  • Several clinical and pre-clinical product candidates targeting areas including ocular allergy, dry eye and other inflammatory eye conditions, and
  • A manufacturing process that can be used to repurpose existing drugs by producing novel, patentable nanocrystalline forms.

“This proposed acquisition is another significant step forward in Nicox' 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,” Nicox Chairman and CEO Michele Garufi said in a statement. “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.”

Nicox agreed to acquire all outstanding shares of Aciex cash-free and debt-free through a reverse triangular merger. The transaction would give Aciex shareholders $65 million upfront, entirely in the form of 20,627,024 newly issued Nicox shares, plus contingent value rights (CVRs) giving right to Nicox shares based on potential FDA approval(s) of AC-170 and of two additional undisclosed products within a pre-determined period.

The CVRs include $35 million for U.S. 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—a figure that drops to $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—as well as $10 million each for the following two US product approvals by July 1, 2021. 

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