Fera Pharmaceuticals Obtains Orphan Drug Designation from the FDA for Naproxcinod for the Treatment of Sickle Cell Disease

Nicox SA and Fera Pharmaceuticals announced that the FDA has granted Orphan Drug Designation for naproxcinod for the treatment of sickle cell disease, which affects an estimated 100,000 Americans. Naproxcinod is a nitric oxide (NO)-donating naproxen combining the cyclooxygenase (COX) inhibitory activity of naproxen with that of nitric oxide developed by Nicox and exclusively licensed to Fera in the US. Nicox has tested naproxcinod in over 2,700 patients in osteoarthritis, generating a significant package of clinical safety data which is available to support Fera’s development of naproxcinod, and ultimately a new drug application submission for sickle cell disease.

“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,” said Michele Garufi, Chief Executive Officer and Chairman of Nicox. “Fera has already carried out pre-clinical development work on naproxcinod in models of sickle cell disease, and the extensive clinical package already developed by Nicox positions the molecule – the first that was taken into clinical development by our company – for an accelerated development.”

“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,” added Frank DellaFera, Founder and Chief Executive Officer of Fera Pharmaceuticals.