Nicox Updates on Fera Pharmaceuticals’ Continuing Evaluation of Naproxcinod

April 30, 2021 – release at 7:30 am CET
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.