February 21, 2022 – release at 7:30 am CET
Nicox S.A. (Euronext Paris: FR0013018124, COX), an international society of ophthalmology, today announces that the Chinese National Intellectual Property Administration (CNIPA) has granted the company a formulation patent for NCX 470, its lead product candidate. in development for patients with open-angle glaucoma or ocular hypertension, extending coverage in China through 2039. With equivalent US and European patents already granted, the formulation is now covered in most major global territories. The NCX 470 is also covered by issued composition of matter patents.
Gavin Spencer, Chief Commercial Officer of Nicox, noted: “The granting of this formulation patent in China, in addition to recent EU and US grants, further strengthens the protection around our lead product candidate, the NCX 470, and enabless our partner in ChinaOcumension Therapeutics, to benefit from a period of exclusivity while securing Nicox’s flow of royalties on sales in China. Our Phase 3 clinical trials, Mont Blanc and Denali, continue to progress and we look forward to the submission new drug applications in the United States and China to bring NCX470 to patients in these important markets.”
NCX 470, Nicox’s lead product candidate, is a novel nitric oxide (NO)-donating prostaglandin analog designed to deliver bimatoprost and NO to the eye. NCX 470 is currently being evaluated against latanoprost, the leading prostaglandin analogue by prescription volume in the United States, in ongoing Phase 3 Mont Blanc and Denali clinical trials, with results expected in the first quarter of 2023 and d by the end of 2023, respectively.
Nicox has licensed exclusive rights from Ocumension for the NCX 470 in China, Korea and Southeast Asia. Ocumension paid Nicox €18 million for these rights and is also funding 50% of the total cost of the Denali Phase 3 clinical trial. Nicox will receive tiered royalties of between 6% and 12% on sales of NCX 470 by Ocumension. Ocumension is a Chinese ophthalmology company listed on the Hong Kong Stock Exchange since July 2020 (HKEX: OCUMENSION-B (1477)).
NCX 470 is designed to release both bimatoprost and NO after instillation into the eye. Bimatoprost, marketed under the brand name LUMIGAN® by Allergan, Inc., is a leading product in the prostaglandin analog class, the most widely used drug class for lowering IOP in patients with open-angle glaucoma or ocular hypertension.
Nicox is headquartered in Sophia Antipolis, France, is listed on Euronext Paris (Compartment C: Mid Caps; Ticker: COX) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indices.
For more information about Nicox, its products or its pipeline, please visit: www.nicox.com.
Bryan, Garnier & Co Dylan van Haaften Paris, France
Edison Investment Research Pooya Hemami London, United Kingdom
HC Wainwright & Co Yi Chen New York, USA
Kepler Cheuvreux Damien Choplain Paris, France
Executive Vice President, Chief Business Officer
& Business Development Manager
T +33 (0)4 97 24 53 00
Investor & Media
United States and Europe
LifeSci Advisors, LLC
Sandya von der Weid
T +41 78 680 05 38
The risk factors likely to have a significant effect on Nicox’s business are presented in the 3rd chapter of ‘Universal registration document, annual financial report and management report 2020‘ filed with the French Financial Markets Authority (AMF) on March 1, 2021 and in the 2n/a chapter of the amendment to the “Universal Registration Document, annual financial report and management report 2020» filed with the AMF on December 9, 2021 which are available on the Nicox website (www.nicox.com).
Building 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