April 13, 2021

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Nicox Highlights Productive 2020 Progress Development and Medical Milestones for 2021

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Nicox Highlights Profitable 2020 Progress Progress and Medical Milestones for 2021


 

  • Initiated two Phase 3 trials with NCX 470 in glaucoma and a Phase 2b demo with NCX 4251 in blepharitis in 2020
  • Spouse Ocumension Therapeutics initiated a Stage 3 trial in China with ZERVIATE™ in allergic conjunctivitis in December 2020
  • Top-line success for NCX 470 Mont Blanc Section 3 demo and NCX 4251 Mississippi Phase 2b trial the two now thanks in Q4 2021

January 5, 2021 – launch at 7:30 am CET
Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an global ophthalmology business, today highlighted the robust progress in its enhancement applications in 2020 and the critical scientific milestones predicted in 2021.

 

Michele Garufi, Chairman and Chief Government Officer of Nicox, mentioned “ We have positioned ourselves as a big participant among international ophthalmic R&ampD firms.  We realized superb development in 2020 with the get started of four significant scientific trials, covering our three main assets, inspite of the difficult surroundings brought on by the COVID-19 pandemic.  Looking ahead, we assume important milestones in 2021, over all the final results from late-stage medical trials with our guide property NCX 470 and NCX 4251.  Furthermore, thanks to our distinctive benefit of owning licensing revenue from two solutions commercialized in the U.S., and partnered in other marketplaces, we anticipate steadily growing profits for quite a few decades to arrive to assistance our expansion.”

Overview of Our Late-Phase Clinical Pipeline

      ·NCX 470, Nicox’s lead medical product or service applicant, a novel nitric oxide (NO)-donating prostaglandin analog, is staying evaluated in the Mont Blanc and Denali Stage 3 clinical trials for the reducing of intraocular tension (IOP) in sufferers with open-angle glaucoma or ocular hypertension.  Top-line outcomes are at present envisioned in Q4 2021 for Mont Blanc and in Q4 2022 for Denali.  Together Mont Blanc and Denali trials will assist New Drug Software (NDA) submissions in the U.S. and China.

  • NCX 4251, a novel patented ophthalmic suspension of fluticasone propionate nanocrystals, is remaining evaluated in the Mississippi Period 2b scientific trial for the cure of acute exacerbations of blepharitis.  Major-line results are at present expected in Q4 2021.  If prosperous in assembly the primary efficacy endpoint formerly agreed with the U.S. Foods and Drug Administration (Fda), the Mississippi demo could depict the to start with of two pivotal trials needed to aid the submission of an NDA for the treatment method of blepharitis in the U.S.  
  • ZERVIATE™, (cetirizine ophthalmic solution), .24%, the first and only topical ophthalmic formulation of the antihistamine cetirizine, is remaining evaluated in a confirmatory Section 3 scientific demo in China by our companion Ocumension, to aid a Chinese New Drug Application.  ZERVIATE is previously commercialized in the U.S. by our partner Eyevance Pharmaceuticals, which was acquired by Santen Pharmaceutical Co., Ltd of Japan in September 2020 for $225 million.

We carry on to carefully check out the unfold and effects of the COVID-19 pandemic.  We do not currently foresee delays in our medical timelines but we are checking the predicament and will present an update when wanted.


About Nicox


Nicox S.A. is an worldwide ophthalmology organization creating modern methods to assistance maintain eyesight and boost ocular overall health.  Nicox’s direct method in scientific advancement is NCX 470, a novel, next-generation nitric oxide-donating prostaglandin analog, for decreasing intraocular stress in clients with glaucoma.  The business is also producing NCX 4251, a proprietary formulation of fluticasone, for acute exacerbations of blepharitis.  Nicox generates revenue from VYZULTA® in glaucoma, licensed exclusively around the world to Bausch + Lomb, and ZERVIATE™ in allergic conjunctivitis, certified in various geographies, such as to Eyevance Prescribed drugs, LLC, in the U.S. and Ocumension Therapeutics in the Chinese and in the the vast majority of South East Asian marketplaces. 

Nicox is headquartered in Sophia Antipolis, France, is outlined on Euronext Paris (Compartment B: Mid Caps Ticker image: COX) and is element of the CAC Healthcare, CAC Pharma &amp Bio and Future 150 indexes.

For extra info on Nicox, its goods or pipeline, you should stop by: www.nicox.com.


Analyst protection


 

Bryan, Garnier &amp Co        Victor Floc’h           Paris, France
Cantor Fitzgerald             Louise Chen           New York, U.S.
H.C. Wainwright &amp Co      Yi Chen                   New York, U.S.
Kepler Cheuvreux               Damien Choplain Paris, France
Oppenheimer &amp Co          Hartaj Singh            New York, U.S.

 


The views expressed by analysts in their coverage of Nicox are those of the author and do not replicate the views of Nicox. Furthermore, the information and facts contained in their studies may possibly not be right or present-day.  Nicox disavows any obligation to appropriate or to update the facts contained in analyst stories.


Contacts


Nicox
Gavin Spencer
Government Vice President, Chief Company Officer
&amp Head of Company Development 
T +33 ()4 97 24 53 00
[email protected]


Traders &amp Media
United States &amp Europe
LifeSci Advisors, LLC
Mary-Ann Chang
T +44 7483 284 853
[email protected]

Media
France
LifeSci Advisors, LLC
Sophie Baumont
M +33 ()6 27 74 74 49
[email protected]


Ahead-Wanting Statements


The details contained in this doc may well be modified with out prior see.  This facts features ahead-wanting statements. Such ahead-searching statements are not ensures of upcoming effectiveness.  These statements are based on latest expectations or beliefs of the management of Nicox S.A. and are issue to a number of things and uncertainties that could result in actual outcomes to vary materially from people described in the forward-searching statements.  Nicox S.A. and its affiliate marketers, directors, officers, workforce, advisers or brokers, do not undertake, nor do they have any obligation, to offer updates or to revise any ahead-hunting statements.

Hazards elements which are most likely to have a substance impact on Nicox’s small business are presented in the 3rd chapter of the ‘ Document d’enregistrement universel, rapport financier annuel et rapport de gestion 2019 ’ submitted with the French Autorité des Marchés Financiers (AMF) on March 6, 2020 which are available on Nicox’s internet site ( www.nicox.com ) and as restated in the 4th chapter of the 50 % yearly economical report as of June 30, 2020, which is also offered on Nicox’s site.


Nicox S.A.
Drakkar 2
Bât D, 2405 route des Dolines
CS 10313, Sophia Antipolis
06560 Valbonne, France
T +33 ()4 97 24 53 00
F +33 ()4 97 24 53 99