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NicOx S.A. is a French pharmaceutical company and the CEO is Michele Garufi. Its headquarters are at Sophia Antipolis (U.S. headquarters in Warren, New Jersey, opened in October 2007). Louis Ignarro, co-recipient of the 1998 Nobel Prize in Physiology or Medicine for demonstrating the signalling properties of nitric oxide, is a member of the scientific committee of the company and Bengt Samuelsson, Nobel laureate 1982 serves as director on the company board.
|Traded as||Euronext: COX|
|Michele Garufi (Chairman of the board)|
|Revenue||€3,36 million (2009)|
|€73,887 million (2008)|
|Total equity||€102,069 million (2009)|
Number of employees
|Subsidiaries||NicOx Research Institute Srl, NicOx Inc.|
The company focuses on the uses of the medical properties of nitric oxide. It has several molecules in the pipeline, and its lead compound was an anti-inflammatory drug, naproxcinod, of the CINOD (COX-inhibiting nitric oxide donator) class for the treatment of osteoarthritis. This class of drugs was first described by Dr. John L. Wallace and colleagues. The company has ongoing development partnerships with Bausch & Lomb and Merck.
NicOx was financed with venture capital provided by a syndicate including Apax France, Sofinnova, Auriga and HealthCap. The company went public on the Paris Stock Exchange in 1999. The market capitalisation of the company was $1 billion as of January 2008. It is listed on Euronext, the French stock exchange and is part of the CAC Mid 100 stock market index. It has been included in the SBF 120 index since 18 June 2007. Oppenheimer Funds is its first shareholder with 25% of its capital.
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Naproxcinod was the company's lead compound until 2011. The company finished three phase III clinical trials. The first of these studies to be published showed that naproxcinod had similar efficacy to naproxen (measured in WOMAC Pain, function and patient global assessment) in controlling signs and symptoms of osteoarthritis. It has been well documented that non-steroidal anti-inflammatory drugs increase blood pressure, and naproxen is one of the safest in this regard. Meanwhile, naproxcinod had similar effects on blood pressure to placebo (which is considered neutral), while the comparator naproxen (sold under the brand Aleve in the United States) showed a statistically significant increase in blood pressure. This difference was especially marked for those patients taking RAS blockers (ACE inhibitors, ARBs and beta blockers). This means that naproxcinod could have become an option for patients with osteoarthritis who needed to take NSAIDs.
In September 2009, NicOx filed for regulatory approval of naproxcinod with the United States Food and Drug Administration (FDA) and the European Medicines Agency. On 12 May 2010, an FDA advisory committee voted against approval, questioning the safety of the drug. NicOx has appealed this decision. Subsequently, in April 2011, the company withdrew its European application after it became clear that an EU expert panel was going to fail to render a positive review of NicOx's clinical data.
- "Here's a French Biotech Investors May Not Care About Enough". Bloomberg.com. Retrieved 2018-08-08.
- John L. Wallace homepage at Farncombe Institute, McMaster University
- Wallace JL, Reuter B, Cicala C, McKnight W, Grisham MB, Cirino G (July 1994). "Novel nonsteroidal anti-inflammatory drug derivatives with markedly reduced ulcerogenic properties in the rat". Gastroenterology. 107 (1): 173–179. PMID 8020659.
- "NicOx pulls drug application, shares plunge". Reuters. 20 April 2011. Retrieved 21 April 2011.
- "Nicox Buys Aciex for up to $120M".
- William B. White; Thomas J. Schnitzer; Rosana Fleming; Brigitte Duquesroix; Maarten Beekman (5 May 2009), "Effects of the Cyclooxygenase Inhibiting Nitric Oxide Donator Naproxcinod Versus Naproxen on Systemic Blood Pressure in Patients With Osteoarthritis", American Journal of Cardiology, Elsevier (published 15 September 2009), 104 (6), pp. 840–845, doi:10.1016/j.amjcard.2009.05.014, ISSN 1879-1913, OCLC 39263367, PMID 19733721, retrieved 21 April 2011
- Frishman, William H. (21 March 2002), "Effects of nonsteroidal anti-inflammatory drug therapy on blood pressure and peripheral edema", American Journal of Cardiology, Elsevier, 89 (6), pp. 18–25, doi:10.1016/s0002-9149(02)02233-6, ISSN 1879-1913, OCLC 39263367, retrieved 21 April 2011
- Schnitzer, Thomas J.; Hochberg, Marc C.; Marrero, Christopher E.; Duquesroix, Brigitte; Frayssinet, Hayet; Beekman, Maarten (February 2011). "Efficacy and safety of naproxcinod in patients with osteoarthritis of the knee: a 53-week prospective randomized multicenter study". Seminars in Arthritis and Rheumatism. 40 (4): 285–297. doi:10.1016/j.semarthrit.2010.06.002. ISSN 1532-866X. PMID 20828790.