Nicox Announces Approval of ZERVIATE in China

Press Release
Nicox Announces Approval of ZERVIATE in China
Nicox’s partner, Ocumension Therapeutics, has received approval for ZERVIATE^® for ocular itching in China ZERVIATE^® launch in China will add a further royalty revenue stream for Nicox September 18, 2024 – release at 7:30 am CET Sophia Antipolis, France Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that its exclusive Chinese partner, Ocumension Therapeutics, has received approval of the New Drug Application (NDA) to commercialize ZERVIATE^® (cetirizine ophthalmic solution), 0.24% in China for ocular itching associated with allergic conjunctivitis. “The approval of ZERVIATE for commercialization in China is an excellent achievement by our partner, Ocumension Therapeutics. We trust in their capabilities to support a quick launch and use their strong commercial presence across China to maximize market penetration. This new commercial launch will add another revenue stream to Nicox as we will receive from 5% to 9% royalties and commercial milestones on Ocumension’s net sales of ZERVIATE in China. Ocumension forecasts peak sales in excess of $100 million annually within 7 years.” said Emmet Purtill, VP Business Development of Nicox. ZERVIATE is the first and only eye drop formulation of the antihistamine cetirizine, the active ingredient in ZYRTEC^®, and is currently commercialized in the U.S. for ocular itching associated with allergic conjunctivitis by Nicox’s exclusive U.S. partner, Harrow, Inc. Ocumension emphasizes that ZERVIATE is suitable for the treatment of allergic conjunctivitis in toddlers and preschoolers, which significantly fills the medical gap in this field and benefits the vast number of children in China. Ocumension plans to manufacture ZERVIATE in their new state-of-the-art purpose-built manufacturing facility located in Suzhou, China. ZERVIATE will be promoted by Ocumension’s commercial team and its extensive network of national and provincial distribution partners. The prescription market for allergic conjunctivitis products in China is expected¹ to grow to almost $500 million by 2030. ZERVIATE is exclusively licensed to Ocumension for development and commercialization in the Chinese and the majority of the Southeast Asian markets. Nicox may potentially receive sales milestones of up to US$17.2 million together with royalties from 5% to 9% of net sales of ZERVIATE by Ocumension. Since Nicox’s recent successful financing, Ocumension is now its principal shareholder.
About Nicox
Nicox SA 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 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nicox generates revenue from VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets. Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX) and is part of the CAC Healthcare index. For more information www.nicox.com
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H.C. Wainwright & Co Yi Chen New York, U.S.
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Contacts
Nicox Gavin Spencer Chief Executive Officer T +33 (0)4 97 24 53 00 communications@nicox.com	Media / Investors Sophie Baumont Cohesion Bureau +33 6 27 74 74 49 sophie.baumont@cohesionbureau.com
Disclaimer
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 section 3 of the “Rapport Annuel 2023” which is available on Nicox’s website (www.nicox.com). Finally, this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail.
Nicox S.A. Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, France T +33 (0)4 97 24 53 00