Source: NICOX

VYZULTA Approved in Canada by Nicox's Partner

Press Release
VYZULTA Approved in Canada by Nicox's Partner
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January 4, 2019 - release at 7:30 am CET
Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that its partner has received approval in Canada of VYZULTATM (latanoprostene bunod ophthalmic solution), 0.024%.  Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Bausch Health Companies Inc. (NYSE/TSX: BHC) and exclusive global licensee for VYZULTATM, announced the approval yesterday.  VYZULTATM is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Michele Garufi, Chairman and Chief Executive Officer of Nicox, said: "The Canadian approval of VYZULTA, its first approval outside the U.S., is excellent news and sets the stage for what we believe should be a strong year for Nicox.  In 2019 we anticipate for ZERVIATE a U.S. commercial launch by our partner Eyevance and potential additional licensing agreements in other geographies.  Therefore, between the revenues from VYZULTA royalties from Bausch + Lomb and the future royalty streams from ZERVIATE, we look forward to a continuous and progressive income for Nicox for the next several years."

 

Nicox receives increasing tiered net royalties of 6% to 12% on global sales of VYZULTATM as well as up to $150 million in net sales milestones linked to global sales.

 

Bausch + Lomb's announcement (dated January 3, 2019) regarding this approval can be accessed by the following link: https://www.newswire.ca/news-releases/bausch-lomb-announces-health-canada-approval-of-vyzulta-tm-latanoprostene-bunod-ophthalmic-solution-0-024-for-the-treatment-of-glaucoma-897268417.html.

 
About Nicox
Nicox S.A. is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health.  By leveraging our proprietary expertise in nitric oxide (NO) donation and other technologies, we are developing an extensive portfolio of novel product candidates that target multiple ophthalmic conditions, including glaucoma.  Our portfolio includes three programs in development including NCX 470 for intraocular pressure lowering, based on our proprietary NO-donating research platform and NCX 4251, a proprietary formulation of the well-established molecule fluticasone, for acute exacerbations of blepharitis.  Our research activities are focused on novel future generation NO-donors including NO-donating phosphodiesterase-5 (PDE5) inhibitors and NO-donating soluble guanylate cyclase (sGC) stimulators (in partnership with Ironwood).  In addition, we have two ophthalmology assets that have been approved by the U.S. Food and Drug Administration (FDA); VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024%, exclusively licensed worldwide to Bausch + Lomb, a Bausch Health Companies Inc. company, and commercialized in the U.S. by Bausch + Lomb since December 2017, as well as ZERVIATE(TM) (cetirizine ophthalmic solution), 0.24%, exclusively licensed in the U.S. to Eyevance Pharmaceuticals.  

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   Hugo Solvet    Paris, France
Invest Securities   Martial Descoutures    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.
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Contacts
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Gavin Spencer,
Executive Vice President, Chief Business Officer
T +33 (0)4 97 24 53 00
communications@nicox.com
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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 the 4th chapter of the 'Document de référence, rapport financier annuel et rapport de gestion 2017' filed with the French Autorité des Marchés Financiers (AMF) on March 19, 2018 which is 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 +33 (0)4 97 24 53 00
F +33 (0)4 97 24 53 99

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