Firm now faced with the prospect of new long-term safety trials.

NicOx shares took a steep nosedive and hit a 52-week low as a result of yesterday’s announcement that FDA would not sanction the firm’s lead anti-inflammatory drug, naproxcinod, based on the submitted NDA. Having completed its review of the September 2009-submitted NDA for naproxcinod, the agency has recommended NicOx carry out additional long-term studies to evaluate naproxcinod’s cardiovascular and gastrointestinal safety as well as undertake new trials to demonstrate that the therapeutic benefits of the drug are due to its nitric oxide-donating capabilities.

FDA’s decision was not wholly unexpected given the recommendations of its Arthritis Drugs Advisory Committee and Drug Safety and Risk Management Committee, which back in May voted 16 to 1 against approving the drug. The European regulatory authorities are still reviewing an equivalent MAA, which NicOx submitted in December 2009.

NicOx’ share price plummeted over 20%, going down as low as €2.17 yesterday before stabilizing at about €2.25 as NicOx’ home country of France settled down to lunch today.

NicOx, while stressing that it had cash, cash equivalents, and financial instruments amounting to some €138.5 million as of March 31, has yet to disclose what its gut feelings are on continuation of naproxcinod development. The firm says it intends to discuss “potential next steps as early as possible with FDA”.

NicOx is applying its nitric oxide-donating R&D platform to develop an internal portfolio of NMEs for the potential treatment of inflammatory, cardiometabolic, and ophthalmological diseases. Naproxcinod is a cyclooxygenase-inhibiting nitric oxide-donating (CINOD) anti-inflammatory and the firm’s first CINOD pipeline drug to complete Phase III.

The risks of late-stage drug development have not been lost on the firm, however. Within days of the FDA’s committee’s recommendations against approval of naproxcinod, NicOx confirmed that it would hold back on starting an in-house Phase II study with nitric oxide (NO)-donating HMG-CoA reductase inhibitor NCX 6560, “until clarification of naproxcinod’s regulatory position.” NCX 6560 is in development for use in reducing the risk of major adverse cardiac events coronary heart disease (CHD) patients.

In March the firm inked a $10 million up-front licensing deal granting Bausch & Lomb exclusive, worldwide rights to develop and commercialize NCX 116 (previously PF 03187207), a nitric oxide donating prostaglandin F2-alpha analog. The firm had previously carried out two Phase II studies comparing the drug with Xalatan® in the treatment of patients with primary open angle glaucoma or ocular hypertension.

The NicOx pipeline also includes a Phase I-stage collaboration with Merck & Co. to develop nitric oxide-donating antihypertensives and a preclinical-stage partnership with Grupo Ferrer to develop nitric oxide-donationg anti-inflammatories for the treatment of skin disorders.Research-stage projects in diabetic retinopathy, inflammation/pain, and cardiometabolic indications are also in progress. In June NicOx reported promising preclinical data on its diabetic macular edema candidate NCX434, and its lead preclinical candidate for neuropathic pain, NCX 1236.

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