Nicox Announces First Commercial Sale of ZERVIATE in China by Partner Ocumension, Creating a New Recurrent Revenue Stream

• First commercialized product from the Nicox-Ocumension collaboration
• Recent acquisitions have enhanced OcuMension’s leadership in the ophthalmology field in the China market
• Product made available quickly after approval thanks to a rapid manufacturing campaign at Ocumension’s state-of-the-art factory
• Major milestone for this strong collaboration, which also includes our lead asset, NCX 470, where recruitment was just completed in the Denali Phase 3 trial

December 4, 2024 – release at 7:30 am CET
Sophia Antipolis, France

Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced the first commercial sale of ZERVIATE® (cetirizine ophthalmic solution), 0.24% in China by its exclusive Chinese partner Ocumension Therapeutics. ZERVIATE is indicated for ocular itching associated with allergic conjunctivitis and was approved in China in September 2024.

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.

“The first commercial sale of ZERVIATE in China by our partner Ocumension, marks the next significant milestone in this broad collaboration initiated in 2018 and provides a new revenue stream for Nicox. Ocumension has proven itself to be a strong development partner through their work on ZERVIATE and on the recruitment of Chinese patients in the NCX 470 Denali Phase 3 study. They have also been building out commercial operations through organic and external growth, including acquiring products and operations from a leading player in China, ideally placing them to maximise the value of ZERVIATE in the Chinese market. We look forward to continuing to work with them as we advance NCX 470 towards commercialisation as well.” said Gavin Spencer, Chief Executive Officer of Nicox.  

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% on net sales of ZERVIATE by Ocumension. 

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 also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos.  Nicox’s first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories.  Nicox generates revenue from 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

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” and in section 4 of the “Rapport semestriel financier et d’activité 2024” which are 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.