NicOx S.A. (Euronext Paris: COX) today reported financial results for the nine months ended September 30, 2009.
Michele Garufi, Chairman and CEO of NicOx, declared: "In the third quarter of 2009, we have achieved an important corporate milestone by submitting the NDA for naproxcinod on time to the US FDA and we have continued to drive our strategy to transform NicOx into a specialty pharmaceutical company through increasing the pre-commercialization activities for our lead compound, which is raising more and more interest from rheumatologists and cardiologists, as well as from the wider scientific community. We remain confident that naproxcinod has the potential to make a significant difference to osteoarthritis sufferers and are committed to participating in its expected commercial success. Moreover, our promising earlier stage pipeline is also progressing as planned and we look forward to announcing further clinical and pre-clinical milestones later this year."
Key operational highlights of the third quarter of 2009:
- Submission of a New Drug Application (NDA) for naproxcinod to the United States Food and Drug Administration (FDA), seeking approval for an indication for the relief of the signs and symptoms of osteoarthritis (OA) - see press release of September 25, 2009. The NDA file contains data from three large pivotal phase 3 studies, all of which met their co-primary efficacy endpoints. NicOx plans to submit a Marketing Authorization Application (MAA) for naproxcinod to the European Medicines Agency (EMEA) in Q4 2009.
- Publication of an important scientific article in the September issue of the American Journal of Cardiology which describes the blood pressure results from the 301 phase 3 study for naproxcinod in detail. The differentiated blood pressure profile of naproxcinod 750 mg bid and naproxcinod 375 mg bid, when compared to placebo and naproxen 500 mg bid on the systolic blood pressure (SBP) of patients with OA of the knee, was presented in the article.
- Three scientific presentations at the 2009 World Congress on Osteoarthritis (OARSI - annual congress of the Osteoarthritis Research Society International). The presentations included the efficacy results for naproxcinod from the 302 study completed in 2008 and the preclinical results obtained with two other CINOD compounds.
- Reacquisition of the full development and commercialization rights to NCX 116 (previously PF-03187207) from Pfizer, which has completed two phase 2 studies in patients with primary open angle glaucoma and ocular hypertension. As part of this agreement, Pfizer also granted NicOx the right to access and use certain proprietary Xalatan® (latanoprost) data. NicOx also regained rights to a number of novel, research-stage, nitric oxide-donating compounds for the potential treatment of diabetic retinopathy and glaucoma.