Nicox has entered into an exclusive licensing agreement with Eyevance Pharmaceuticals for the commercialization of Zerviate (cetirizine ophthalmic solution) 0.24% in the United States.
Under the terms of the agreement, effective September 20, 2017, Eyevance will make a one-time, upfront payment of $6 million to Nicox. Nicox is eligible to receive up to an additional $42.5 million in future milestones, of which $5 million is related to near-term manufacturing objectives managed by Nicox. The remaining $37.5 million are payable on Eyevance achieving predefined sales targets, with $30 million of these milestones being triggered by annual sales targets of $100 million and above. In addition, Nicox will also receive tiered royalties of 8-15% based on future net sales of Zerviate. Nicox has agreed to provide pre-launch manufacturing support to Eyevance and will also be responsible, at its own cost, for completing the requisite scale-up activities for the manufacturing of the commercial product and the professional samples necessary for the launch.
"We believe that Eyevance, led by its experienced executive management team, has the financial resources and know-how to execute the planned launch of Zerviate and to maximize the commercial potential of this unique product in the US market," Gavin Spencer, Executive Vice President of Corporate Development at Nicox, said in a company news release. "The FDA approval of Zerviate, together with the commercial experience and ophthalmic expertise of Eyevance, provides us with a strong foundation on which to begin pursuing the expansion of Zerviate into additional markets."
Zerviate (formerly AC-170), approved by the FDA on May 30, 2017, is the first topical ocular formulation of the antihistamine cetirizine approved for the treatment of ocular itching associated with allergic conjunctivitis. Cetirizine, the active ingredient in the systemic drug Zyrtec, is a second-generation antihistamine which has a well-characterized systemic efficacy and safety profile with worldwide exposure resulting from 20 years of oral use.
"Zerviate is a strong first asset for Eyevance to lead off its commercial strategy focused on important ophthalmic conditions, especially given the significant awareness around cetirizine in the market and by prescribers," Jerry St. Peter, Founder and Chief Executive Officer of Eyevance, said in a company news release. "We welcome the opportunity to work with the Nicox team to bring this product to market and to providing practitioners and patients with access to Zerviate. We look forward to further establishing Eyevance's presence within the ophthalmic marketplace and being a trusted and respected partner."