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Nov 18 2009, 11:26 AM EST

NicOx Completes $44.92M Fundraising as FDA Accepts NDA for Osteoarthritis Drug

GEN News Highlights

NicOx completed a €30 million (about $44.92 million) private placement with institutional investors. The company separately reported that the FDA accepted its NDA submission for lead osteoarthritis drug, naproxcinod.

The fundraising included a €20 million (about $29.95 million) cornerstone investment by Fonds Stratégique d’Investissement (FSI), which as a result now owns 5.1% of NicOx. Proceeds from the financing round will be used to support NicOx’ drive to become a fully integrated specialty pharmaceuticals company.

NicOx is focused on developing a pipeline of nitric oxide-donating drugs. Naproxcinod is a cyclooxygenase-inhibiting nitric oxide-donating (CINOD) anti-inflammatory agent being developed for relieving the signs and symptoms of osteoarthritis. In addition to its recent NDA submission, NicOx says that it also aims to file for regulatory approval in Europe by the end of this year.

Just last week the company reported positive results from a Phase Ib study with NCX 6560, a nitric oxide-donating HMG-CoA reductase inhibitor in development for cardiovascular indications. The trial, evaluating NCX 6560 versus placebo and Lipitor®, met its primary and secondary endpoints and demonstrated a strong cholesterol-lowering effect in patients with high baseline LDL cholesterol levels.

“The role of NO in preventing pathological processes in the vasculature suggests NCX 6560 could have the potential to reduce the occurrence of serious cardiovascular adverse events such as stroke and heart attack in coronary heart disease patients,” notes Pascal Pfister, CSO and head of R&D at NicOx. “In light of these results, we are keen to see NCX 6560 advanced into Phase II.”

 

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Related News
NicOx Reacquires Nitric Oxide-Donating Ophthalmology Compounds from Pfizer (Aug. 6, 2009)
DSM to Lend Manufacturing Support for NicOx’ Anticipated Osteoarthritis Drug Launch (Dec. 2, 2008)
NicOx Signs On Archimica as Commercial Supplier of Phase III Osteoarthritis Therapeutic (Mar. 19, 2008)
NicOx to Receive €3M in Funding through One-Year Extension of Opthamology Deal with Pfizer (Jan. 8, 2008)
NicOx Achieves First Milestone of Euro 5M From Merck (Jan. 18, 2007)

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