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 Chemical Entities (NCEs) for the potential treatment of inflammatory, cardiometabolic and ophthalmological diseases. Resources are focused on the development and pre-commercialization activities for naproxcinod, a proprietary NCE and the first-in-class Cyclooxygenase-Inhibiting Nitric Oxide-Donating (CINOD) anti-inflammatory agent for the relief of signs and symptoms of osteoarthritis. NicOx submitted a New Drug Application (NDA) for naproxcinod to the US Food and Drug Administration (FDA) in September 2009 and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) in December 2009, following the successful completion of three pivotal phase 3 studies. NicOx received a communication in November 2009 from the FDA stating that the NDA was accepted for filing. Based on the Prescription Drug User Fee Act (PDUFA), the FDA will complete its review 10 months after submission and has set an action date of July 24, 2010. In addition to naproxcinod, NicOx’s pipeline includes several nitric oxide-donating NCEs, which are in development internally and with partners, including Merck & Co., Inc., for the treatment of widespread eye diseases, cardiometabolic diseases, hypertension, respiratory disorders 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' most advanced investigational drug, naproxcinod, has successfully 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. NicOx submitted a New Drug Application (NDA) for naproxcinod to the US Food and Drug Administration (FDA) in September 2009 and received a communication in November 2009 from the FDA stating that the NDA was accepted for filing. A Marketing Authorization Application (MAA) was submitted to the European Medicines Agency (EMEA) in December 2009. 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 NCX 116 (formerly called PF-03187207) is a nitric oxide-donating prostaglandin F2-alpha analog developed for the treatment of glaucoma. While they did not meet the pre-defined primary endpoint, two phase 2 studies completed in 2008 evidenced that it potentially benefits from a better and more sustained intraocular pressure effect than the market’s leading drug for the treatment of glaucoma. NicOx regained the full development and commercialization rights to NCX 116 from Pfizer Inc. in August 2009, and Pfizer has granted NicOx the right to access and use certain proprietary Xalatan data. The Company is therefore evaluating opportunities for advancing NCX 116 into Phase 3 clinical development, most likely with a strategic partner.



	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. and Grupo Ferrer Internacional, S.A. More on co-development... ....More on research alliances...

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