NicOx signs agreement for commercial manufacture of Naproxcinod drug substance

Mar 20 2008

NicOx S.A. (Euronext Paris: COX) has announced it has signed an agreement with the fine chemical company Archimica, for the commercial manufacturing and supply of naproxcinod drug substance (or active pharmaceutical ingredient, API).

Naproxcinod is NicOx' lead investigational product and the first compound in the COX-Inhibiting Nitric Oxide-Donating (CINOD) class of anti-inflammatory agents. The aim of this agreement is to secure commercial supplies of an appropriate scale to ensure the successful commercial launch of naproxcinod. The filing of a New Drug Application (NDA) for naproxcinod with the U.S. Food and Drug Administration (FDA) is projected for mid-2009.

Michele Garufi, Chairman and CEO of NicOx, declared: "We are very happy to have signed this agreement with Archimica, which is an essential step as we advance naproxcinod towards the market. With Archimica's extensive manufacturing experience and history of producing APIs for the U.S. and other major markets, NicOx is in a strong position to prepare the regulatory submissions and subsequent market launch of naproxcinod. We now have a large capacity producer, which is capable of supporting the high commercial potential of naproxcinod that has been suggested by our market research."

Under the agreement, Archimica will supply naproxcinod API from Archimica's FDA inspected site in Springfield, Missouri, making Archimica a significant component of NicOx' supply chain for naproxcinod. As per the agreement, NicOx envisages the first deliveries of significant quantities of commercial material being made from the fourth quarter of 2009 onwards, following the installation of dedicated equipment required to manufacture naproxcinod API. NicOx evaluated more than ten potential suppliers for the manufacture of naproxcinod API, prior to the signature of this agreement with Archimica, and may conclude agreements with up to two additional suppliers. This is part of NicOx' strategy to maximize the commercial potential and economic value of naproxcinod, as NicOx owns the global development and marketing rights to this compound. Going forward, NicOx will be looking for co-commercialization partnerships for naproxcinod, with NicOx retaining certain commercialization rights in the U.S. and selected EU markets, in order to fully exploit the drug's commercial and strategic value and to aid the Company's planned transition to a fully integrated pharmaceutical business.

James Harrison, CEO of Archimica, declared: "We are very pleased to have this opportunity to apply our expertise to the manufacturing of naproxcinod and are excited by the clear potential of this innovative product. We look forward to continuing our work with the NicOx team, and leveraging our manufacturing experience to support their timely and successful launch of naproxcinod."

NicOx is developing naproxcinod in phase 3 clinical studies, which are designed to demonstrate that it is safe, well tolerated and effective for treating the signs and symptoms of osteoarthritis, in addition to having no detrimental effect on blood pressure, in contrast to existing Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). The final pivotal phase 3 trials are ongoing (the 302 and 303 studies) and the filing of a New Drug Application (NDA) for naproxcinod is projected for mid-2009.

About Archimica

Archimica is a privately held pharmaceutical fine chemicals company owned by TowerBrook Capital Partners and Aisling Capital Partners. Archimica combines first-class chemical manufacturing assets, technologies and process development with a history of pharmaceutical commercialization that stretches back over 40 years. With respect to new manufacturing projects, Archimica's strategy is focused on phase 2 and phase 3 clinical trial manufacturing opportunities for New Chemical Entities (NCEs) and this partnership with NicOx on naproxcinod is an important example of this strategy. In addition, through partnerships with generic pharmaceutical businesses, Archimica is building its product portfolio for the generic pharmaceutical industry.

NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a product-driven biopharmaceutical company dedicated to the development and future commercialization of investigational drugs for unmet medical needs. NicOx is applying its proprietary nitric oxide-donating technology to develop an internal portfolio of NCEs in the therapeutic areas of inflammatory and cardio-metabolic disease.

Resources are focused on the development of naproxcinod, a proprietary NCE and the first compound in the COX-Inhibiting Nitric Oxide-Donating (CINOD) class of anti-inflammatory agents, which is in phase 3 clinical studies for the treatment of the signs and symptoms of osteoarthritis, with final phase 3 results anticipated in 2008.

Beyond naproxcinod, NicOx has a pipeline containing multiple nitric oxide-donating NCEs, which are in development internally and with partners, including Pfizer Inc and Merck & Co., Inc., for the treatment of prevalent and underserved diseases, such as atherosclerosis, hypertension, glaucoma and Chronic Obstructive Pulmonary Disease (COPD).

NicOx S.A. is headquartered in France and is listed on the Euronext Paris Stock Exchange (Compartment B: Mid Caps).