Nicox and Fera Pharmaceuticals to Focus on a Rare Disease Indication for Naproxcinod

Nicox SA and Fera Pharmaceuticals announced that they have amended their 2015 license agreement, which granted Fera exclusive rights to develop and commercialize naproxcinod for the U.S. market. The development of naproxcinod will now focus on an undisclosed rare disease, for which Fera expects to seek an orphan drug designation from the FDA.

Naproxcinod, a Cyclooxygenase-Inhibiting Nitric Oxide (NO)-Donating (CINOD) naproxen, is a non-steroidal anti-inflammatory product candidate originally discovered and developed by Nicox.

“We are delighted that Fera intends to take the development of naproxcinod in a new direction, which could potentially lead to an orphan drug designation for naproxcinod in a rare disease,” Michele Garufi, Chairman and Chief Executive Officer of Nicox, said in a company news release. “Fera should benefit from the existing chemistry, manufacturing and control data and the extensive nonclinical and clinical safety database for naproxcinod to support a potentially accelerated clinical development program.”

“Naproxcinod has the potential to become an FDA approved drug targeting an unmet medical need in a rare disease,” Frank DellaFera, Founder and President of Fera Pharmaceuticals, said in the news release. “Fera has conducted an extensive review and based on naproxcinod’s NO-donating activity, along with its pain-relieving properties, we are looking forward to its further development to potentially provide patients with an important new treatment option.” 

Nicox and Fera have agreed that the collaboration will now be focused on an undisclosed rare disease. Fera may submit, subject to a successful completion by Fera of a preclinical proof-of-concept study, an application for an orphan drug designation for naproxcinod to the FDA. Fera believes that naproxcinod may be able to enter directly into a clinical efficacy study if the orphan drug designation is obtained. 

Under the amended agreement, Nicox will now be eligible to potentially receive a single $40 million, sales-based milestone if naproxcinod reaches $1 billion yearly sales (for any indication) in the United States. This milestone would be payable only once. The royalties remain unchanged at 7% of net sales of naproxcinod in the U.S. Other than as specified in the amendment, Fera remains responsible for all clinical development, manufacturing, regulatory and commercialization activities.