COX Nicox SA

Nicox Updates on ZERVIATE Progress in China and Expands the Countries of its Agreement with Ocumension Therapeutics

Nicox Updates on ZERVIATE Progress in China and Expands the Countries of its Agreement with Ocumension Therapeutics

Press Release
Nicox Updates on ZERVIATETM Progress in China and Expands the Countries of its Agreement with Ocumension Therapeutics
 



  • Ocumension’s ZERVIATETM exclusive rights expanded to include South Eastern Asian countries
  • Ocumension preparing to file an IND with the Chinese CDE (Center for Drug Evaluation) for a clinical study expected to start in Q4 2020
 



March 11, 2020 – release at 7:35 am CET

Sophia Antipolis, France



Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that it has amended its March 2019 license agreement with Ocumension Therapeutics granting Ocumension exclusive rights to develop and commercialize ZERVIATETM (cetirizine ophthalmic solution), 0.24% for the treatment of allergic conjunctivitis in the Chinese market.  Under the amended agreement, Ocumension now also has exclusive rights of ZERVIATE in the majority of South East Asian Region.  



In addition to the expansion of our deal with Ocumension on NCX 470, also announced today, we have decided to broaden our relationship on ZERVIATE, adding this important emerging area of Asian markets to the original license,” said Gavin Spencer, Chief Business Officer of Nicox.  “Ocumension has commenced construction of a new manufacturing site in China which will ultimately be able to manufacture ZERVIATE and therefore be well-placed to supply these additional territories.”



“The development teams at Ocumension and Nicox have been working together to prepare the Chinese IND.  We expect to file this shortly and be in a position to start a Phase 3 clinical trial for approval in China by Q4 2020,” said Ye Liu, Chief Executive Officer of Ocumension.  



Amendment Agreement Terms



Ocumension has exclusive rights in the original and expanded territories to develop and commercialize ZERVIATE for the treatment of allergic conjunctivitis.  Other terms of the original agreement remain unchanged and Nicox may potentially receive development and sales milestones of up €17 million together with tiered royalties of between 5% and 9% on sales of ZERVIATE.
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 has three programs in development including NCX 470, a novel, second-generation NO-donating bimatoprost analog, 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 Cyclerion).  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™ (cetirizine ophthalmic solution), 0.24%, exclusively licensed in the U.S. to Eyevance Pharmaceuticals, LLC. 



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: .
About Ocumension Therapeutics
Ocumension is a China-based company with a mission of being a pioneer in Ophthalmology.  It develops and provides prescription medicines that meet the evolving needs of patients, healthcare professionals, and caregivers.  With its experienced group, Ocumension's capabilities span from research and development to clinical trial execution to marketing and sales of in-licensed and wholly owned products.  Aiming to help more patients, Ocumension is building its portfolio of new medications and technologies through internal research & development and strategic alliances with global partnerships.
Analyst coverage
 



Bryan, Garnier & Co    Victor Floc’h   Paris, France

Cantor Fitzgerald    Louise Chen  New York, U.S.

H.C. Wainwright & Co   Yi Chen  New York, U.S.

Oppenheimer & 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 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 +33 (0)4 97 24 53 00

Investors & Media

United States & Europe

LifeSci Advisors, LLC

Hans Herklots

T 9 

Media

France

LifeSci Advisors, LLC

Sophie Baumont

M +33 (0)6 27 74 74 49

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 2019’ filed with the French Autorité des Marchés Financiers (AMF) on March 6, 2020 which are available on Nicox’s website ().
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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11/03/2020

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