Nicox Updates on Fera Pharmaceuticals’ Continuing Evaluation of Naproxcinod
|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.
|Naproxcinod is a nitric oxide (NO)-donating naproxen combining the cyclooxygenase (COX) inhibitory activity of naproxen with that of NO (COX-inhibiting NO donor, CINOD). While the inhibitory COX component provides the analgesic and anti-inflammatory efficacy, the NO part may play a significant role in maintaining vascular endothelial cell function and integrity, blood pressure homeostasis and microvascular circulation. A broad clinical package already exists for naproxcinod in osteoarthritis, including three phase 3 trials with over 2,700 patients.|
|About Fera Pharmaceuticals|
|Fera Pharmaceuticals is a privately held company. The company goal is to realize opportunities via acquisitions, in-licensing, developing and marketing abbreviated new drug applications (ANDAs), new drug applications (NDAs) and 505(b)(2) NDA products. Areas of interest include products that could benefit from lifecycle management with a special focus on niche markets. For more information visit www.ferapharma.com.|
|Nicox S.A. is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead program in clinical development is NCX 470, a novel nitric oxide-donating prostaglandin analog, for lowering intraocular pressure in patients with glaucoma. The company is also developing NCX 4251, a proprietary formulation of fluticasone, for acute exacerbations of blepharitis. Nicox generates revenue from VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Eyevance Pharmaceuticals, LLC, in the U.S. and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets. |
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: www.nicox.com.
Bryan, Garnier & Co Victor Floc’h Paris, France
Cantor Fitzgerald Louise Chen New York, U.S.
Edison Investment Research Pooya Hemami London, UK
H.C. Wainwright & Co Yi Chen New York, U.S.
Kepler Cheuvreux Damien Choplain Paris, France
|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.|
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
T +44 7483 284 853
LifeSci Advisors, LLC
M +33 (0)6 27 74 74 49
|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 2020’ filed with the French Autorité des Marchés Financiers (AMF) on March 1, 2021 which are available on Nicox’s website (www.nicox.com).
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
Upcoming Life Sciences Events
- May 2021
- European Health-tech Innovation Week
- 7th Annual Immuno-Oncology Innovation Forum
- Pharma-Biotech Product & Company Valuation Course
Latest company news
OSE Immunotherapeutics Announces €10.7 Million in Additional Public Funding, via Bpifrance, to Finance Further Development of CoVepiT, its Multi-Target and Multi-Variant COVID-19 Vaccine in Phase 1 Clinical Phase