NicOx Company Profile

	NicOx company profile


	NicOx is a pharmaceutical company focused on the research, development and future commercialization of drug candidates. NicOx is applying its proprietary nitric oxide-donating R&D platform to develop an internal portfolio of New Molecular Entities (NMEs) for the potential treatment of inflammatory, cardiometabolic and ophthalmological diseases. Resources are focused on the development and pre-commercialization activities for naproxcinod, a proprietary NME and the first-in-class Cyclooxygenase-Inhibiting Nitric Oxide-Donating (CINOD) anti-inflammatory agent developed for the relief of signs and symptoms of osteoarthritis. The naproxcinod Marketing Authorization Application (MAA) submitted by NicOx in December 2009 is currently under review by the European Medicines Agency (EMA). In July 2010, the US Food and Drug Administration (FDA) provided a Complete Response Letter to the New Drug Application (NDA) for naproxcinod stating that it does not approve the naproxcinod application. NicOx plans to discuss the Complete Response Letter and potential next steps as early as possible with the FDA. In addition to naproxcinod, NicOx’s pipeline includes several nitric oxide-donating NMEs, which are in development internally and with partners, including Merck & Co., Inc. and Bausch + Lomb, for the treatment of hypertension, cardiometabolic diseases, widespread eye diseases and dermatological disease. NicOx aims to build itself into a fully integrated specialty pharmaceutical company, with its own sales force targeting specialist physicians in the United States, as well as innovative internal R&D programs. NicOx has strategic partnerships, collaborative agreements and research alliances with some of the world's leading pharmaceutical companies and specialist players, which allow it to maximize the value of its technology and broad portfolio, while allowing the Company to retain future commercialization rights in select areas.



	Three core therapeutic areas Inflammatory, cardiometabolic and ophthalmolic diseases Naproxcinod – Signs and symptoms of Osteoarthritis NicOx's most advanced investigational drug, naproxcinod, has completed a clinical phase 3 program in patients with osteoarthritis of the knee and hip. Anti-inflammatory agents currently used in the treatment of osteoarthritis (traditional NSAIDs and COX-2 inhibitors) have long been associated with a range of side effects, including gastrointestinal problems. Furthermore, clinical findings continue to cast significant doubt on their cardiovascular safety, including their association with increased blood pressure. Naproxcinod is a unique nitric oxide-donating anti-inflammatory compound and the first CINOD (Cyclooxygenase-Inhibiting Nitric Oxide Donator) in late-phase development. NicOx aims to demonstrate that naproxcinod is an anti-inflammatory agent with no detrimental effect on blood pressure and good gastrointestinal tolerability and safety. NicOx has completed a regulatory phase 3 program for naproxcinod in patients with OA of the knee (the 301 and 302 studies) and hip (the 303 study), with all three studies achieving highly statistically significant results on all three co-primary efficacy endpoints. The naproxcinod Marketing Authorization Application (MAA) submitted by NicOx in December 2009 is currently under review by the European Medicines Agency (EMA). In July 2010, the US Food and Drug Administration (FDA) provided a Complete Response Letter to the New Drug Application (NDA) for naproxcinod stating that it does not approve the naproxcinod application. NicOx plans to discuss the Complete Response Letter and potential next steps as early as possible with the FDA. More on naproxcinod... NCX 6560 - Cardiometabolic In November 2009, NicOx announced that a phase 1b, first-in-man study for NCX 6560, versus placebo and Lipitor® (atorvastatin), had met its primary and secondary objectives. The top-line results demonstrated very good safety and tolerability for all the tested doses of NCX 6560, as well as the expected cholesterol lowering profile. NCX 6560 is an innovative nitric oxide (NO)-donating HMG-CoA Reductase Inhibitor, which has the potential to be developed as a new treatment to further reduce the risk of major adverse cardiac events (MACEs) in Coronary Heart Disease (CHD) patients. More on NCX 6560... NCX 116 - Glaucoma - with Bausch + Lomb NCX 116 (formerly called PF-03187207) is a nitric oxide-donating prostaglandin F2-alpha analog developed for the treatment of glaucoma. NicOx and Bausch + Lomb, a leading eye health company entered in March 2010 into a licensing agreement which grants Bausch + Lomb exclusive worldwide rights to develop and commercialize NCX 116. NCX 116 has completed two phase 2 studies in patients with glaucoma and ocular hypertension that demonstrated promising results. More on NCX 116...



	Creating Value Through Partnerships While NicOx plans to develop its lead products internally, the Company seeks to maximize the value of its portfolio and expertise in nitric oxide-donation through major strategic partnerships and research alliances on non-core products and therapeutic areas. The Company has alliances with Merck & Co., Inc., Bausch + Lomb and Grupo Ferrer Internacional, S.A. More on partnerships...

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