SOPHIA ANTIPOLIS, France, December 2 /PRNewswire-FirstCall/ -- NicOx S.A. (NYSE Euronext Paris: COX) today announced it has signed an agreement with DSM for the commercial manufacture and supply of naproxcinod drug substance (or API, active pharmaceutical ingredient). Naproxcinod is NicOx' lead investigational product and the first compound in the Cyclooxygenase-Inhibiting Nitric Oxide-Donating (CINOD) class of anti-inflammatory agents, which recently achieved positive results in the third pivotal phase 3 study in osteoarthritis patients.
Under the terms of the agreement, DSM will supply naproxcinod API for commercial purposes from its fine chemicals production site in Linz, Austria. DSM is one of the world's leading independent suppliers to the pharmaceutical industry, with some 40% of today's top-selling medicines in the world containing ingredients developed and produced by DSM. This follows the signature of an agreement with Capsugel in September 2008 for the commercial manufacture of naproxcinod oral capsules, which is widely recognized as the world leader in capsule manufacturing.
Staffan Stromberg, Vice President of Technical Development and Operations at NicOx, commented: "The latest positive results observed in the 111 and 303 studies support our confidence in naproxcinod's blockbuster potential. We are therefore very pleased to have signed these contracts with global leaders in high capacity API and capsule production. We project these agreements should cover the high sales forecasts for the initial years of naproxcinod's commercialization that have been suggested by our market research."
The agreement with DSM aims to secure commercial supplies of an appropriate scale to support the successful launch of 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 this agreement with DSM and the importance of cost control in the current economic environment, NicOx has ended its present API supply agreement with Archimica. At the point of termination, Archimica had met all contract milestones and was in full compliance with the other terms of the contract.
Luca Mantovani, President & Business Unit Director at DSM Pharma Chemicals, declared: "We are happy to consolidate our relationship with NicOx through this agreement. Naproxcinod is an exciting compound and being part of its pre-launch and future commercialization plans is an interesting opportunity for DSM."
On November 24, NicOx announced that the third pivotal phase 3 study for naproxcinod in osteoarthritis of the hip had met all three co-primary efficacy endpoints. Following the positive results from the 301 and 302 studies in osteoarthritis of the knee, 303 represents the third pivotal phase 3 study for naproxcinod to achieve p<0.001 on all three co-primary efficacy endpoints. In addition, naproxcinod 750 mg bid showed the same gastrointestinal (GI) adverse event rate and a similar blood pressure profile to placebo in the 303 study.
This followed the announcement of positive results from a 118 patient Ambulatory Blood Pressure Monitoring (ABPM) trial (the 111 study) on November 4, where naproxcinod showed a statistically significant reduction in systolic blood pressure of 3.8 mmHg (p=0.011) compared to naproxen over the whole study period. The filing of a New Drug Application (NDA) for naproxcinod with the U.S. Food and Drug Administration (FDA) is projected for mid-2009.
DSM - the Life Sciences and Materials Sciences Company
Royal DSM N.V. creates innovative products and services in Life Sciences and Materials Sciences that contribute to the quality of life. DSM's products and services are used globally in a wide range of markets and applications, supporting a healthier, more sustainable and more enjoyable way of life. End markets include human and animal nutrition and health, personal care, pharmaceuticals, automotive, coatings and paint, electrics and electronics, life protection and housing. DSM has annual sales of almost EUR8.8 billion and employs some 23,000 people worldwide. The company is headquartered in the Netherlands, with locations on five continents. DSM is listed on the NYSE Euronext Amsterdam. More information: http://www.dsm.com.
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 New Chemical Entities (NCEs) in the therapeutic areas of inflammatory and cardio-metabolic disease.
Resources are focused on the development and pre-commercialization activities for naproxcinod, a proprietary NCE and the first compound in the Cyclooxygenase-Inhibiting Nitric Oxide-Donating (CINOD) class of anti-inflammatory agents for the treatment of the signs and symptoms of osteoarthritis. Naproxcinod has completed three pivotal phase 3 studies with positive results and the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) is projected for mid-2009.
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, widespread eye diseases and Chronic Obstructive Pulmonary Disease (COPD).
NicOx S.A. is headquartered in France and is listed on the NYSE Euronext Paris (Compartment B: Mid Caps).
This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated in the forward-looking statements.
For a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of NicOx S.A. to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the Document de Reference filed with the AMF, which is available on the AMF website (http://www.amf-france.org) or on NicOx S.A.'s website (http://www.nicox.com).
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