Published on December 22, 2009 at 3:18 AM
NicOx S.A. (NYSE Euronext Paris: COX) today announced that a Marketing
Authorization Application (MAA) for naproxcinod has been submitted to the
European Medicines Agency (EMEA) through the centralized procedure, seeking
approval for an indication for the relief of the signs and symptoms of
osteoarthritis (OA). This follows the submission of a New Drug Application
(NDA) to the US Food and Drug Administration (FDA) in September that has
recently been accepted for filing.
Naproxcinod is NicOx's lead investigational compound and the first in a new
class of anti-inflammatory agents known as CINODs
(Cyclooxygenase-Inhibiting Nitric Oxide Donators). The MAA file is
supported by data from a large program of 34 clinical trials that involved
more than 4,000 subjects treated with naproxcinod. The program evaluated
the efficacy of naproxcinod in relieving signs and symptoms of
osteoarthritis, as well as its safety, with a particular care given to its
effect on blood pressure.
Philippe Serrano, Vice President Regulatory Affairs at NicOx, commented:
"As planned, we have ended 2009 with the regulatory submissions for
naproxcinod both in Europe, where we have just submitted an MAA through the
centralized procedure, as well as the United States, where the FDA has
recently accepted our NDA for filing."
Pascal Pfister, Chief Scientific Officer and Head of Research & Development
at NicOx, added: "We are proud of all the achievements of our team during
these last few years, including the completion of these important
milestones on time. We will enter 2010 with confidence and are looking
forward to working with the FDA and the EMEA during their review of the
naproxcinod data."
SOURCE: NICOX