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, under which Ocumension has exclusive rights to develop and commercialize ZERVIATE® (cetirizine ophthalmic solution), 0.24% in the Chinese and the majority of South East Asian markets.  Under the amended agreement, Ocumension will immediately pay Nicox $2 million in full advance payment of the future development and regulatory milestones for the product.  Amendments were made to certain rights under non-financial clauses of the agreement.

Nicox remains eligible to receive the same sales milestones of up to US$17.2 million together with tiered royalties of between 5% and 9% of net sales of ZERVIATE by Ocumension.  ZERVIATE is currently being evaluated in a confirmatory Phase 3 clinical trial in China by Ocumension, to support a Chinese New Drug Application for the treatment of ocular itching associated with allergic conjunctivitis.

ZERVIATE is the first and only topical ocular formulation of the antihistamine cetirizine and has been commercialized in the United States since March 2020 by Nicox’s exclusive U.S. licensee, Eyevance Pharmaceuticals, a wholly-owned subsidiary of Santen (Japan).  In addition to Ocumension for the Chinese and the majority South East Asian markets, ZERVIATE is also exclusively licensed to Samil Pharmaceutical in South Korea, to ITROM Pharmaceutical Group in certain Gulf and Arab markets and to Laboratorios Grin for Mexico.

Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, announced that the last patient in the NCX 4251 Mississippi Phase 2b blepharitis clinical trial has now completed the two-week treatment phase as well as the required two-week follow up period.  Top-line results are expected to be announced in September 2021.

“The Phase 2b Mississippi trial is designed to further explore the NCX 4251 product profile following the encouraging results of the Phase 2 Danube trial,” said Dr. José Boyer, Interim Head of R&D at Nicox, “The Mississippi trial includes a number of clinical endpoints related to signs and symptoms of blepharitis and dry eye disease.  We will therefore generate a significant amount of data which will be used to guide the future development of NCX 4251.  We will announce the next steps in the development of NCX 4251 following an End-of-Phase 2 meeting with the FDA.”

NCX 4251 is a novel patented ophthalmic suspension of fluticasone propionate nanocrystals.  The direct administration of NCX 4251 to the eyelids is designed to target the site of the inflammation whilst minimizing the intraocular exposure to the steroid fluticasone, thereby reducing the risk of adverse effects such as increased intraocular pressure and cataract.

Mississippi is a Phase 2b clinical trial of NCX 4251, evaluating once-daily dosed NCX 4251 0.1% versus placebo in patients with acute exacerbations of blepharitis, and has recruited over 200 patients.  The primary outcome measure is the proportion of patients achieving at Day 15 complete cure in eyelid redness, eyelid debris and eyelid discomfort, the hallmark signs and symptoms of blepharitis.

 Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, presented results from the Dolomites Phase 2 clinical trial showing that NCX 470, a novel nitric oxide (NO)-donating prostaglandin analog (PGA), produced significantly greater intraocular pressure (IOP) lowering effects in glaucoma patients compared with the current standard of care, latanoprost.

In Dolomites, a dose-response Phase 2 clinical trial evaluating three concentrations of NCX 470 compared to latanoprost ophthalmic solution, 0.005% in 433 patients with open-angle glaucoma or ocular hypertension, NCX 470 0.065% achieved superiority compared to latanoprost 0.005% at all time points on day 28 with up to 1.4 mmHg superior IOP lowering.  All tested concentrations of NCX 470 were non-inferior to latanoprost and the dose response of NCX 470 showed improved IOP lowering with each incremental concentration.  NCX 470 was safe and well-tolerated with no drug-related serious adverse events and no evidence of treatment-related systemic side effects.  The presentation of the results by Dr. David Wirta, one of the clinical investigators in the trial, is available during the World Glaucoma Congress 2021 (June 30 to July 3 2021).  The Dolomites trial was completed in late 2019 and the results are detailed here.

“The Phase 2 Dolomites trial demonstrated that NCX 470 has the potential to be a new standard of care for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension.  These impressive data showed superior efficacy against latanoprost, the most prescribed prostaglandin analog for patients with open-angle glaucoma or ocular hypertension, and importantly, also suggested that greater efficacy may be possible at concentrations higher than those used in this dose-ranging trial,” said Dr. Wirta, Medical Director, Eye Research Foundation, Newport Beach, CA, USA and one of the clinical investigators in the Dolomites trial, “NCX 470 was well-tolerated, and the highest dose used in the trial suggests that a higher dose (0.1%) currently being evaluated in Phase 3 has the potential for greater IOP lowering without significant additional risk.”

NCX 470 is currently in two multi-regional Phase 3 glaucoma clinical trials, Mont Blanc and Denali.  The objective with these two trials is to demonstrate statistically superior efficacy of once-daily dosed NCX 470 ophthalmic solution 0.1% over latanoprost ophthalmic solution 0.005% (first marketed as Xalatan), the most prescribed PGA in the U.S., for the lowering of IOP.  Results from the first Phase 3 trial, Mont Blanc, are currently expected in Q2 2022.  Results from the second Phase 3 trial, Denali, are now expected in 2023, previously announced as Q4 2022.

Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that its exclusive global licensee Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., has received approval for VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% in the United Arab Emirates.

Now approved in 12 countries, VYZULTA is commercialized in the United States (since 2017), Canada (2019), Argentina (2020), Mexico (2020), Hong Kong (2020) and Taiwan (2021).  It is also approved in Brazil, Colombia, Qatar, South Korea, Ukraine and the 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 and other territories that have the same indication.  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.

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 plus up to $150 million in potential future milestone payments

Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, announced that results from the Dolomites Phase 2 clinical trial on NCX 470 in patients with open-angle glaucoma or ocular hypertension will be presented by Dr. David Wirta, Medical Director, Eye Research Foundation (Newport Beach, CA, USA), at the World Glaucoma E-Congress 2021 being held from June 30 – July 3, 2021. Dr. Wirta is one of the clinical investigators in the Dolomites trial.

Dr. Wirta’s presentation will be available from June 30, 2021 on the website of the World Glaucoma E-Congress via a link dedicated to the E-posters.

Nicox’s lead clinical development product candidate, NCX 470 is a novel NO-donating prostaglandin analog in late-stage clinical development for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, announced that as of today, more than 200 patients, the pre-defined target, have been randomized in the NCX 4251 Mississippi Phase 2b blepharitis clinical trial.  Top-line results are expected to be announced during September 2021.

“Blepharitis is a highly prevalent eye condition with frequent exacerbation of signs and symptoms suffered by millions of patients, and there remains a significant unmet need for an effective treatment,” said Dr. José Boyer, Interim Head of R&D at Nicox, “The successful completion of the Mississippi trial enrollment on time in the current pandemic environment is testament to the strength and dedication of our clinical team, investigators and the Clinical Research Organization managing the trial.  We look forward to announcing the results, which will drive the preparation of the next steps in the development of this novel asset, in a few months’ time.”

NCX 4251 is a novel patented ophthalmic suspension of fluticasone propionate nanocrystals.  The direct administration of NCX 4251 to the eyelids is designed to target the site of the inflammation whilst minimizing the intraocular exposure to the steroid fluticasone thereby reducing the risk of adverse effects such as increased intraocular pressure and cataract.

Mississippi is a Phase 2b clinical trial of NCX 4251, evaluating once-daily dosed NCX 4251 0.1% versus placebo in patients with acute exacerbations of blepharitis.

The primary outcome measure is the proportion of patients achieving complete cure in eyelid redness, eyelid debris and eyelid discomfort, the hallmark signs and symptoms of blepharitis, at Day 15.  Should NCX 4251 meet this primary efficacy endpoint for blepharitis, the Mississippi trial could represent the first of two pivotal trials needed to support an NDA in the U.S. for the treatment of acute exacerbations of blepharitis.

Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced the signature of an exclusive license agreement with Laboratorios Grin, a wholly-owned subsidiary of Lupin Limited, for the registration and commercialization of ZERVIATETM (cetirizine ophthalmic solution), 0.24% for the treatment of ocular itching associated with allergic conjunctivitis in Mexico.  Grin is a Mexican specialty pharmaceutical company engaged in the development, manufacturing and commercialization of branded ophthalmic products.

Gavin Spencer, Chief Business Officer of Nicox, said: “With this licensing deal we welcome the first Latin American partner to our ZERVIATE collaboration portfolio, showing the continued worldwide interest by specialist ophthalmic companies in new entrants in the allergic conjunctivitis space.  Laboratorios Grin are leaders in ophthalmology in Mexico, with over 60 years of experience in this field, and so are the ideal partner for Nicox to commercialize our ZERVIATE in this market.  With in-house manufacturing and regulatory capabilities, Laboratorios Grin will be able to manage all aspects of the process to approve ZERVIATE, relying on the U.S. filing to support their regulatory submission.”

Grin is granted rights to develop and commercialize cetirizine ophthalmic solution, 0.24% in Mexico.  Nicox will receive an undisclosed license fee and potential milestone payments linked to regulatory approval and sales, and is eligible to receive double digit royalties on net sales of ZERVIATE.  Grin will be responsible, at its own cost, for the development, manufacturing and the commercialization of ZERVIATE in Mexico.

Luis Guillermo Cortés, VP and Managing Director Laboratorios Grin, said: “We are thrilled to partner with Nicox for ZERVIATE and to bring to Mexico state-of-the-art innovation for patients suffering from allergic conjunctivitis.  By leveraging our strong commercial and manufacturing capabilities, we hope to improve the quality of life of many patients affected with this medical condition”.

About ZERVIATE

ZERVIATETM (cetirizine ophthalmic solution), 0.24% is a novel formulation of cetirizine developed and approved for the first time for topical application in the eye for the treatment of ocular itching associated with allergic conjunctivitis.  Cetirizine, the active ingredient in ZYRTEC®, is a second-generation antihistamine (H1 receptor antagonist) that binds competitively to histamine receptor sites.  Cetirizine, in approved oral formulations, has a well-characterized systemic efficacy and safety profile with worldwide exposure resulting from 20 years of oral use.  ZERVIATE was developed by Nicox as the first and only formulation of cetirizine for topical application in the eye.

ZERVIATE, commercialized in the United States since March 2020 by Eyevance Pharmaceuticals, Nicox’s exclusive U.S. licensee, is also licensed exclusively to Ocumension Therapeutics in the Chinese and certain Southeast Asian markets, Samil Pharmaceutical in South Korea and ITROM Pharmaceutical Group for Gulf and Arab Markets.

About Allergic Conjunctivitis

Allergic conjunctivitis occurs when an allergic reaction causes conjunctivitis.  Conjunctivitis is an inflammation of the thin layer of tissue that lines the outside of the white surface of the eye and the inner surface of the eyelids.  It may affect one or both eyes.  The signs and symptoms may include eye redness, excessive watering, itchy burning eyes, discharge, blurred vision and increased sensitivity to light

Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that its exclusive global licensee Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., has launched VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% in Taiwan.  Regulatory approval in Taiwan was obtained in March 2020.  VYZULTA has also recently received approval in Qatar.

In addition to Taiwan, VYZULTA is commercialized in the United States (since 2017), Canada (2019), Argentina (2020), Mexico (2020) and Hong Kong (2020), and is now approved in 5 other territories (Brazil, Colombia, Qatar, South Korea, and Ukraine).  VYZULTA is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension in the United States and other territories that have the same indication.  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.

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 plus up to $150 million in potential future milestone payments.

Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, and Fera Pharmaceuticals, a privately-held, U.S. specialty pharmaceutical company, today provided an update on Fera’s evaluation of naproxcinod for future development.  Fera have been reviewing opportunities for the development of naproxcinod in a number of indications and have conducted pre-clinical development work on naproxcinod in models of both COVID-19 infections and sickle cell disease.

Taking into consideration the data to date in the COVID-19 models and the environment for development of COVID-19 therapeutics, Fera has decided to no longer continue this route of evaluation.  Efforts will continue focusing on sickle cell disease, where Fera has submitted a new application for Orphan Drug Designation (ODD) for naproxcinod in sickle-cell disease, addressing the concerns raised by the U.S. Food and Drug Administration in their refusal letter to the previous application, and other undisclosed therapeutic indications where the properties of naproxcinod may be beneficial.

Naproxcinod, a Cyclooxygenase-Inhibiting Nitric Oxide (NO)-Donating (CINOD) naproxen, is a non-steroidal anti-inflammatory product candidate engineered to release NO and naproxen, originally discovered and developed by Nicox.  Nicox and Fera entered into an agreement in December 2015, amended in September 2018 and December 2020, which granted Fera exclusive rights to develop and commercialize naproxcinod for the U.S. market.  Nicox is eligible to potentially receive a single $40 million sales-based milestone if naproxcinod reaches $1 billion yearly sales (for any indication) in the U.S. as well as royalties of 7% on net sales of naproxcinod in the U.S.  Fera is responsible for all clinical development, manufacturing, regulatory and commercialization activities in the U.S.

Nicox retains all rights to naproxcinod outside the U.S., subject to the payment of royalties to Fera, if intellectual property developed under the agreement is used outside the U.S.

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