NicOx raises 30 million-euro in private placements with backing from French govt's FSI fund; files naproxcinod with FDA

French biotechnology firm NicOx has successfully raised 30 million euros ($44.7 million) through a private placement to institutional investors, including 20 million euros subscribed by the Fonds Strategique d'Investissement (FSI), which will result in the FSI holding a 5.1% stake in the company. The FSI is a French corporation owned 51% by the Caisse des Depots et Consignations and 49% by the French government, which has the objective of supporting medium-sized companies that are considered important for the growth and competitive position of the French economy.

The private placement was conducted without preferential subscription rights to institutional investors by way of an accelerated book-building, pursuant to Article L 411-2-II of the French Code Monetaire et Financier. Due to strong demand from institutional investors (comprising a mix of existing shareholders and new investors), the book was oversubscribed and the company decided to offer the maximum number of shares authorized.

This is the first stage of a planned two-step capital increase, under which the firm aims to raise a total of around 100 million euros. NicOx intends to launch a subsequent rights issue, which will include preferential subscription rights for existing shareholders.

Aiming for own US commercial infrastructure

'We believe this two-step capital increase will support NicOx in achieving its goal of becoming a specialty pharmaceutical company, which could participate in the future sales and marketing of naproxcinod via its own commercial infrastructure in the USA,' said Michele Garufi, chairman and chief executive of NicOx. 'Thanks to these additional financial resources, NicOx will be able to significantly advance the launch preparations for naproxcinod, including the optimization of the commercial supply chain. We feel honored to be one of the industrial projects selected by the FSI, a major strategic investor created by the French Government,' he added.

The company plans to submit a Marketing Authorization Application (MAA) for naproxcinod to the European Medicines Agency (EMEA) before the end of 2009. NicOx intends to use the net proceeds of this financing primarily to continue advancing pre-commercialization activities related to naproxcinod, including the optimization of the supply chain supporting the launch of naproxcinod and the creation of a sales and marketing platform targeting specialist physicians in the US and to develop its proprietary nitric oxide-donating pipeline.

FDA accepts naproxcinod NDA for filing

Meantime, NicOx revealed that the US Food and Drug Administration has accepted for filing its New Drug Application (NDA) for naproxcinod, initially submitted in September, seeking approval of the compound for the relief of the signs and symptoms of osteoarthritis. 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.