Nicox and Fera Pharmaceuticals to Focus on a Rare Disease Indication for Naproxcinod
September 27, 2018
Nicox and Fera Pharmaceuticals have amended their 2015 agreement for naproxcinod
Development, under the responsibility of Fera, will now focus on an undisclosed rare disease, which could potentially lead to an orphan drug designation for naproxcinod
Potential sales-based milestone increased to $40 million if annual sales reach $1 billion
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 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 U.S. Food and Drug Administration (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.
Michele Garufi, Chairman and Chief Executive Officer of Nicox, said, “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. 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.”
Frank DellaFera, Founder and President of Fera Pharmaceuticals, added, “Naproxcinod has the potential to become an FDA approved drug targeting an unmet medical need in a rare disease. 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 U. S. 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.
Our product candidate naproxcinod is a non-steroidal anti-inflammatory drug (NSAID) that is a nitric oxide (NO)-donating naproxen. The NO-donating mechanism of action makes naproxcinod a cyclooxygenase inhibiting nitric oxide donator (CINOD), a class of drugs that are hoped to produce similar analgesic efficacy to traditional NSAIDs, but with an improved gastrointestinal and cardiovascular side effect profile. A broad clinical package already exists for naproxcinod in osteoarthritis, including three phase 3 studies with over 2,700 patients. Nicox submitted an NDA for naproxcinod for osteoarthritis in 2009 and received a Complete Response Letter in 2010 in which the FDA requested substantial additional long-term safety data.
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.