Press Release
Nicox Updates on Corporate, Pipeline and Financing Perspectives and
- Focusing resources on the clinical development of Nicox’s lead program NCX 470 in glaucoma
- NCX 470 Denali Phase 3 trial in patients with open-angle glaucoma or ocular hypertension on track to generate topline results in H2 2025
- Objective of securing financing to support clinical development of NCX 470
- Implementing cost reductions and exploring developing other assets through collaborations
- Webcast (in French) to be held on
March 18, 2024 at6:00 pm CET ; additional details to follow
Sophia Antipolis,
“
Update on Development Pipeline
- NCX 470, our lead clinical asset, is a novel nitric oxide-donating bimatoprost eye drop. The Denali Phase 3 clinical trial evaluating NCX 470 for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, being conducted in the
U.S. andChina , is on track to generate topline results in H2 2025. 80% of the target number of patients have been randomized in the trial and completion of recruitment ofU.S. patients is expected in Q4 2024. Supportive development data required for the preparation of theU.S. New Drug Application (NDA) is expected to be available on or before the completion of the Denali trial. The database from the trial will not be locked until after the last patient has completed their final trial visit inChina , which drives the timing of the Denali results.
The Whistler Phase 3b trial investigating the dual mechanism of action of NCX 470 in IOP lowering is underway and results are expected in Q1 2025. The Phase 3b optical coherence tomography (OCT) trial to investigate the potential benefits of NCX 470 on the retina is not included in the current plan, however this development will be revisited when finances allow. Neither of the two Phase 3b trials are required for an NDA submission in either the
- NCX 1 728, an NO-donating phosphodiesterase-5 (NO-PDE5) inhibitor, is a preclinical asset with potential for development in retinal conditions. The United States Patent Office (USPTO) recently issued the Notice of Allowance for the patent covering NO-PDE5 inhibitors including NCX1728, with an expiry date in 2039. Nonclinical data have demonstrated potential for the development of NCX 1728 in a number of ophthalmic conditions and we are exploring continuing the development of this product candidate through partnerships.
- NCX 4251, a novel suspension of fluticasone propionate nanocrystals, is at development stage for dry eye disease. The Company has agreed a development plan with the
U.S. Food and Drug Administration (FDA) for a Phase 3 program in dry eye disease, and this asset is available for partnering outsideChina . NCX 4251 is licensed to Ocumension inChina who are currently reviewing the pharmaceutical development activities which would be needed to enter in clinical trials inChina .
Update on Revenue Generating Products
- Historically,
Nicox has been generating and reporting royalty revenues from the sales of its products by its partners, primarily Bausch + Lomb for the commercialization of VYZULTA®, and from upfront and milestone payments from its licensing agreements. We expect to add to this the royalty revenue from Ocumension from the commercialization of ZERVIATE® inChina this year and, in the future, from the commercialization of NCX 470 by Ocumension and Kowa, by its future partners in theU.S. and potentially other territories.Nicox estimates annual global net sales of NCX 470 could be over$300 million 1 within 8 years of the date of launches in theU.S. andChina .
- VYZULTA –
Nicox continues to receive royalties on net sales of VYZULTA. Bausch + Lomb, exclusive worldwide partner ofNicox , reported 35% revenue growth for VYZULTA in 2023. VYZULTA is commercialized by Bausch + Lomb in more than 15 countries and territories, including theU.S. , and is also approved in a number of other countries. VYZULTA is indicated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension. - ZERVIATE – Our forecasts assume that the majority of the ZERVIATE revenue will come from the sales of ZERVIATE in
China by our exclusive Chinese partner Ocumension. ZERVIATE is expected to be approved inChina shortly, following submission of the NDA there inApril 2023 . Ocumension forecasts peak annual net sales of over$100 million within 7 years of launch inChina . ZERVIATE is also currently commercialized in theU.S. for ocular itching associated with allergic conjunctivitis byHarrow, Inc. InJanuary 2024 ,Nicox expanded the territory of the exclusive licensing agreement withHarrow, Inc. , to includeCanada . No payment was associated with the extension of the territory, andNicox would receive royalties on any net sales of ZERVIATE inCanada . ZERVIATE forms part of Harrow’s recent agreement with Apotex forCanada .
Update on Cash Runway
The Company is financed to at least
As of
About
For more information www.nicox.com.
Analyst coverage
The views expressed by analysts in their coverage of
Contacts
Chief Executive Officer T +33 (0)4 97 24 53 00 communications@nicox.com | Media / Investors +33 6 27 74 74 49 sophie.baumont@cohesionbureau.com |
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
Risks factors which are likely to have a material effect on Nicox’s business are presented in section 2.7 of the “Rapport Annuel 2022” and in section 4 of the “Rapport semestriel financier et d’activité 2023” which are available on Nicox’s website (www.nicox.com).
Sundesk Sophia Antipolis, Bâtiment C,
T +33 (0)4 97 24 53 00
1 See Press Release of
2 This figure is the contractual amount of the debt which is different from that reported under accounting standards. It does not include the premium of €2.4 million due to BlackRock upon repayment of the non-amortizing, non-convertible bond, which would be paid on January1st, 2026 at the earliest. Nor does it include the Armistice put option granted in the
Attachment
- EN_Nicox-Strategy PR_20240313_F
Source:
2024 GlobeNewswire, Inc., source