Naproxcinod

Nicox’s Partner Fera Pharmaceuticals Obtains Orphan Drug Designation from the U.S. FDA for Naproxcinod for the Treatment of Sickle Cell Disease

Retrieved on: 
Wednesday, March 2, 2022

Nicoxs Partner Fera Pharmaceuticals Obtains Orphan Drug Designation from the U.S. FDA for Naproxcinod for the Treatment of Sickle Cell Disease

Key Points: 
  • Nicoxs Partner Fera Pharmaceuticals Obtains Orphan Drug Designation from the U.S. FDA for Naproxcinod for the Treatment of Sickle Cell Disease
    Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, and Fera Pharmaceuticals, a privately-held, U.S. specialty pharmaceutical company, today announced that the United States (U.S.) Food and Drug Administration (FDA) has granted Orphan Drug Designation for naproxcinod for the treatment of sickle cell disease, which affects an estimated 100,000 Americans.
  • We congratulate Fera on achieving Orphan Drug Designation for naproxcinod, which is a very important step in being able to develop this molecule as a potential treatment for sickle cell disease.
  • We are extremely pleased that the FDA granted Orphan Drug status for naproxcinod as it now allows us to continue our development for sickle cell disease with the benefits that come along with this designation.
  • The FDA Orphan Drug Designation program provides orphan status to drugs and biologics that are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases that affect fewer than 200,000 people in the U.S.

Nicox Updates on Fera Pharmaceuticals’ Continuing Evaluation of Naproxcinod

Retrieved on: 
Friday, April 30, 2021

b'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\xe2\x80\x99s evaluation of naproxcinod for future development.

Key Points: 
  • b'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\xe2\x80\x99s evaluation of naproxcinod for future development.
  • 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.
  • A broad clinical package already exists for naproxcinod in osteoarthritis, including three phase 3 trials with over 2,700 patients.\nFera Pharmaceuticals is a privately held company.
  • Nicox disavows any obligation to correct or to update the information contained in analyst reports.\n'

Nicox’s Partner Fera Pharmaceuticals to Investigate Naproxcinod as Potential Covid-19 Adjuvant Treatment

Retrieved on: 
Friday, December 11, 2020

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, and Fera Pharmaceuticals, a privately-held, U.S. specialty pharmaceutical company, announced today that Fera will evaluate naproxcinod as a potential adjuvant treatment for patients with COVID-19 infection.

Key Points: 
  • Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, and Fera Pharmaceuticals, a privately-held, U.S. specialty pharmaceutical company, announced today that Fera will evaluate naproxcinod as a potential adjuvant treatment for patients with COVID-19 infection.
  • Nicox and Fera entered into an agreement in December 2015 which granted Fera exclusive rights to develop and commercialize naproxcinod for the U.S. market.
  • Nicox and Fera are amending their existing agreement to include COVID-19 as an indication, and Nicox will grant to Fera warrants1 to acquire 10,000 Nicox shares.
  • Once Fera has received the newly manufactured naproxcinod, they plan to initiate proof-of-concept pre-clinical tests in models of COVID-19 infection.

Nicox’s Partner Fera Pharmaceuticals Files Application for Orphan Drug Designation for Naproxcinod in Sickle-Cell Disease

Retrieved on: 
Thursday, April 2, 2020

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, and Fera Pharmaceuticals, a privately-held, U.S. specialty pharmaceutical company, announced today that Fera has filed an application with the U.S. Food and Drug Administration (FDA) for an Orphan Drug Designation (ODD) for naproxcinod in sickle-cell disease.

Key Points: 
  • Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, and Fera Pharmaceuticals, a privately-held, U.S. specialty pharmaceutical company, announced today that Fera has filed an application with the U.S. Food and Drug Administration (FDA) for an Orphan Drug Designation (ODD) for naproxcinod in sickle-cell disease.
  • Following results from in vivo primary pharmacodynamics studies of naproxcinod in models of sickle-cell disease, Fera has decided to focus its development on the treatment of painful vaso-occlusive crisis in sickle-cell disease.
  • Naproxcinod, a Cyclooxygenase-Inhibiting Nitric Oxide (NO)-Donating (CINOD) naproxen, is a non-steroidal anti-inflammatory product candidate engineered to release NO, originally discovered and developed by Nicox.
  • Nicox and Fera entered into an agreement in December 2015, amended in September 2018, which granted Fera exclusive rights to develop and commercialize naproxcinod for the U.S. market.