Shares in NicOx are on the rise this morning after the French biotechnology firm revealed that it has filed its investigational osteoarthritis treatment naproxcinod with regulators in the USA.
The Sophia Antipolis-based group has submitted a New Drug Application to the US Food and Drug Administration for the relief of the signs and symptoms of OA. The filing contains data from three Phase III studies which enrolled more than 2,700 patients with OA of the knee and hip, “all of which met their co-primary efficacy endpoints”, NiCox said, noting that a submission to the European Medicines Agency will take place before the end of the year.
Naproxcinod is the first in a new class of drugs known as CINODs (COX-inhibiting nitric oxide-donators) and Pascal Pfister, NicOx’ head of R&D, noted that “to our knowledge”, the treatment is the first New Chemical Entity anti-inflammatory to be submitted to the FDA for OA since the withdrawal of the COX 2 inhibitors, namely Merck & Co’s Vioxx (rofecoxib) and Pfizer’s Bextra (valdecoxib). The company will be hoping that, if approved, naproxcinod will be a competitor to Pfizer’s other COX-2 inhibitor Celebrex (celecoxib), and some analysts believe it could be a blockbuster.
Chief executive Michele Garufi said the submission of an NDA “is a tremendous achievement for any company and represents a particularly important milestone for NicOx”. He added that it represents another major step in the firm’s “planned transformation into a self-sustainable pharmaceutical company, able to make significant contributions to the successful commercialisation of naproxcinod”.
In order to achieve this goal, “we continue to focus on building NicOx’ future commercial operations in the USA”, Mr Garufi added. The company has previously said it has been in talks with a number of prospective partners and the filing to the FDA should help that search.
NicOx shares were up 3.5% to 9.94 euros at 9.30am UK time.
