Nicox partners with Laboratorios Grin to bring ZERVIATE to Mexico
Press Release Nicox partners with Laboratorios Grin to bring ZERVIATETM to Mexico
May 5, 2021 – release at 7:30 am CET
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 LatinAmerican 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 leadersin ophthalmologyin 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”.
About ZERVIATE
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. About Laboratorios Grin
A wholly owned affiliate of Lupin, present in Mexico for over 50 years, Laboratorios Grin is focused on developing, manufacturing and distributing world-class medicines, and a leader in the ophthalmology segment, primarily in the therapeutic areas of allergic conjunctivitis, dry eye, glaucoma and post-cataract recovery, among others. About Lupin Limited
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions. The Company enjoys leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women’s health areas. Lupin is the third largest pharmaceutical company in the U.S. by prescriptions. For the nine months ended December 31, 2020, the Company invested 9.8% of its revenues on research and development. Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a 'Great Place to Work' in the Biotechnology & Pharmaceuticals sector.
Please visit www.lupin.com for more information.
Follow us on Twitter: www.twitter.com/LupinGlobal | LinkedIn: www.linkedin.com/company/lupin/
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About Nicox Nicox S.A. is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead program in clinical development is NCX 470, a novel nitric oxide-donating prostaglandin analog, for lowering intraocular pressure in patients with glaucoma. The company is also developing NCX 4251, a proprietary formulation of fluticasone, for acute exacerbations of blepharitis. Nicox generates revenue from VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Eyevance Pharmaceuticals, LLC, in the U.S. and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets.
Nicox is headquartered in Sophia Antipolis, France, is listed on Euronext Paris (Compartment B: Mid Caps; Ticker symbol: COX) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indexes.
For more information on Nicox, its products or pipeline, please visit: www.nicox.com. Analyst coverage
Bryan, Garnier & Co Victor Floc’h Paris, France
Cantor Fitzgerald Louise Chen New York, U.S.
Edison Investment Research Pooya Hemami London, UK
H.C. Wainwright & Co Yi Chen New York, U.S.
Kepler Cheuvreux Damien Choplain Paris, France The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports. Contacts Nicox
Gavin Spencer
Executive Vice President, Chief Business Officer
& Head of Corporate Development
T +33 (0)4 97 24 53 00
communications@nicox.com Investors & Media
United States & Europe
LifeSci Advisors, LLC
Mary-Ann Chang
T +44 7483 284 853
mchang@lifesciadvisors.com Media
France
LifeSci Advisors, LLC
Sophie Baumont
M +33 (0)6 27 74 74 49
sophie@lifesciadvisors.com Forward-Looking Statements The information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements.
Risks factors which are likely to have a material effect on Nicox’s business are presented in the 3rd chapter of the ‘Document d’enregistrement universel, rapport financier annuel et rapport de gestion 2020’ filed with the French Autorité des Marchés Financiers (AMF) on March 1, 2021 which is available on Nicox’s website (www.nicox.com). Nicox S.A.
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Bât D, 2405 route des Dolines
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F +33 (0)4 97 24 53 99
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