Nicox Announces ZERVIATE Launch by Partner Eyevance Pharmaceuticals in the United States
March 31, 2020
ZERVIATE, Nicox’s second licensed commercial product in the U.S., will create an additional recurrent revenue stream
ZERVIATE to be marketed by Eyevance, an emerging, specialty ophthalmic company focused on the ocular surface and anterior segment
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that its U.S. licensee, Eyevance Pharmaceuticals, has launched ZERVIATETM in the United States. Commercial supplies were shipped to national wholesalers last week and are now available in pharmacies for patients to fill a prescription. ZERVIATE joins Eyevance’s existing ophthalmic commercial portfolio, including FLAREX®, TOBRADEX® ST and FRESHKOTE® Preservative Free (PF), marketed by their own dedicated sales force. The Eyevance commercial team currently covers 40 key territories in the U.S. ZERVIATE is the first novel prescription-only treatment for allergic conjunctivitis in over 10 years.
“The launch of ZERVIATE in the U.S. is another major step in maximizing the value of ZERVIATE worldwide. The Eyevance team has demonstrated great execution and impactful marketing in building their commercial portfolio and we believe that they are ideally positioned to successfully drive ZERVIATE, the first and only topical ophthalmic presentation of cetirizine, into the U.S. market,” said Gavin Spencer, Chief Business Officer of Nicox.
The press release from Eyevance announcing the launch can be found here, in which Eyevance also sets out how they plan to market ZERVIATE in the current situation, taking into account restrictions due to coronavirus.
Nicox and Eyevance entered into an exclusive licensing agreement for ZERVIATE in the U.S. in September 2017. Eyevance is responsible for all manufacturing, regulatory and commercial activities in the U.S. Nicox is eligible for up to $37.5 million in milestones payable on Eyevance achieving pre-defined sales targets, with $30 million of these milestones being triggered by annual sales of $100 million and above. Nicox will also receive tiered royalties1 of 8% to 15% on future net sales of ZERVIATE in the U.S.
ZERVIATE is also licensed to Ocumension Therapeutics for the Chinese market and the majority of Southeast Asian region, and to Samil Pharmaceutical for South Korea. Nicox currently retains rights to ZERVIATE for all of the other territories outside of the U.S. and those mentioned above.
ZERVIATETM (cetirizine ophthalmic solution), 0.24%, is the first topical ocular formulation of the antihistamine cetirizine for the treatment of ocular itching associated with allergic conjunctivitis. It is estimated that more than 75 million people suffer from allergic conjunctivitis in the United States and the estimated prevalence of allergic conjunctivitis may be between 15% and 40%. The annual U.S. market for prescription treatment of allergic conjunctivitis totaled approximately $400 million in 2018 according to IQVIA Health Analytics. Branded prescription products represent around 70% market share by value. ZERVIATE is a novel formulation of cetirizine, the active ingredient in ZYRTEC®, developed and approved for the first time for topical application in the eye. Cetirizine is a second generation antihistamine (H1 receptor antagonist) that binds competitively to histamine receptor sites. Cetirizine, in approved oral formulations, has a well-characterized systemic efficacy and safety profile with worldwide exposure resulting from 20 years of oral use.
1. Nicox is committed to paying Eyevance consideration for certain manufacturing costs, which will be deducted from these royalty payments, reducing the effective royalty initially to 5% net until such costs are paid.