Nicox Announces VYZULTA Now Commercialized in 7 Territories and Approved in Further 9 Countries

Press Release
Nicox Announces VYZULTA Now Commercialized in 7 Territories and Approved in Further 9 Countries
February 23, 2022 – release at 7:30 am CET Sophia Antipolis, France Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today provides an update on the approvals and launches of VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%, exclusively licensed worldwide by Nicox to Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. “VYZULTA is the first product based on our nitric oxide-donating research platform which has been commercialized, and we are pleased to see the continued rollout of approvals and launches, maximizing the data that were generated for the U.S. NDA. The recent decision by the United States Patent and Trademark Office concerning the eligibility of latanoprostene bunod patents for patent term extension could ensure recurrent revenue from VYZULTA up to 2030 in the United States. In other countries, the revenue stream may go beyond that date.” said Gavin Spencer, Chief Business Officer of Nicox.   As of December 31, 2021, VYZULTA was commercialized in 7 territories: United States (2017), Canada (2019), Argentina (2020), Mexico (2020), Hong Kong (2020), Taiwan (2021) and Ukraine (2021). VYZULTA is also approved in 9 other countries, namely Brazil, Colombia, Jordan, Qatar, Singapore, South Korea, Thailand, Turkey and United Arab Emirates. VYZULTA is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension in the United States. Bausch + Lomb will continue seeking approvals in territories where the clinical data package, part of the U.S. New Drug Application, can be used for approval by the regulatory authorities. Latanoprostene bunod, the active pharmaceutical ingredient in VYZULTA, was invented and patented by Nicox and was licensed to Bausch + Lomb in 2010. Under the terms of the exclusive global license agreement with Bausch + Lomb, Nicox receives increasing tiered royalties of 6% to 12% on net global sales of VYZULTA and is entitled to receive a $20 million milestone payment1 upon VYZULTA net sales reaching $100 million. Nicox maintains the patents for latanoprostene bunod, and the U. S. Patent and Trademark Office recently determined that three U.S. composition of matter patents covering latanoprostene bunod are eligible for patent term extension, potentially through to 2030.
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 open-angle glaucoma or ocular hypertension. The company is also developing NCX 4251, a proprietary formulation of fluticasone, for dry eye disease. 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 C: 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         Dylan van Haaften        Paris, France 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 [phone] [e-mail]	Investors & Media United States & Europe LifeSci Advisors, LLC Sandya von der Weid T [phone] [e-mail]
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 and in the 2nd chapter of the amendment to the “Document d’Enregistrement Universel, rapport financier annuel et rapport de gestion 2020” filed with the AMF on December 9, 2021 which are available on Nicox’s website (www.nicox.com).
Nicox S.A. Drakkar 2 Bât D, 2405 route des Dolines CS 10313, Sophia Antipolis 06560 Valbonne, France T [phone] F [phone]

 

¹ $20 million milestone on $100 million net sales. $15 million of this is payable to Pfizer per the terms of the contract signed in August 2009 by which Nicox recovered the rights to latanoprostene bunod

 

Attachment

• EN_VYZULTA Recap PR_20220223_F

Source: NICOX

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