Nicox partners with Laboratorios Grin to bring ZERVIATE to Mexico
May 5, 2021
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced the signature of an exclusive license agreement with Laboratorios Grin, a wholly-owned subsidiary of Lupin Limited, for the registration and commercialization of ZERVIATETM (cetirizine ophthalmic solution), 0.24% for the treatment of ocular itching associated with allergic conjunctivitis in Mexico. Grin is a Mexican specialty pharmaceutical company engaged in the development, manufacturing and commercialization of branded ophthalmic products.
Gavin Spencer, Chief Business Officer of Nicox, said: “With this licensing deal we welcome the first Latin American partner to our ZERVIATE collaboration portfolio, showing the continued worldwide interest by specialist ophthalmic companies in new entrants in the allergic conjunctivitis space. Laboratorios Grin are leaders in ophthalmology in Mexico, with over 60 years of experience in this field, and so are the ideal partner for Nicox to commercialize our ZERVIATE in this market. With in-house manufacturing and regulatory capabilities, Laboratorios Grin will be able to manage all aspects of the process to approve ZERVIATE, relying on the U.S. filing to support their regulatory submission.”
Grin is granted rights to develop and commercialize cetirizine ophthalmic solution, 0.24% in Mexico. Nicox will receive an undisclosed license fee and potential milestone payments linked to regulatory approval and sales, and is eligible to receive double digit royalties on net sales of ZERVIATE. Grin will be responsible, at its own cost, for the development, manufacturing and the commercialization of ZERVIATE in Mexico.
Luis Guillermo Cortés, VP and Managing Director Laboratorios Grin, said: “We are thrilled to partner with Nicox for ZERVIATE and to bring to Mexico state-of-the-art innovation for patients suffering from allergic conjunctivitis. By leveraging our strong commercial and manufacturing capabilities, we hope to improve the quality of life of many patients affected with this medical condition”.
ZERVIATETM (cetirizine ophthalmic solution), 0.24% is a novel formulation of cetirizine developed and approved for the first time for topical application in the eye for the treatment of ocular itching associated with allergic conjunctivitis. Cetirizine, the active ingredient in ZYRTEC®, 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. ZERVIATE was developed by Nicox as the first and only formulation of cetirizine for topical application in the eye.
ZERVIATE, commercialized in the United States since March 2020 by Eyevance Pharmaceuticals, Nicox’s exclusive U.S. licensee, is also licensed exclusively to Ocumension Therapeutics in the Chinese and certain Southeast Asian markets, Samil Pharmaceutical in South Korea and ITROM Pharmaceutical Group for Gulf and Arab Markets.
About Allergic Conjunctivitis
Allergic conjunctivitis occurs when an allergic reaction causes conjunctivitis. Conjunctivitis is an inflammation of the thin layer of tissue that lines the outside of the white surface of the eye and the inner surface of the eyelids. It may affect one or both eyes. The signs and symptoms may include eye redness, excessive watering, itchy burning eyes, discharge, blurred vision and increased sensitivity to light