SOPHIA ANTIPOLIS, France, September 23 /PRNewswire-FirstCall/ -- NicOx S.A. (Euronext Paris: COX) today announced it has signed an exclusive agreement with Capsugel, the leading producer of two-piece capsules, for the commercial manufacturing and global supply of naproxcinod capsules. Naproxcinod is NicOx' lead investigational product and the first compound in the Cyclooxygenase-Inhibiting Nitric Oxide-Donating (CINOD) class of anti-inflammatory agents. The aim of this agreement is to ensure sufficient supplies of naproxcinod capsules to underpin its successful commercial launch. The filing of a New Drug Application (NDA) for naproxcinod with the U.S. Food and Drug Administration (FDA) is projected for mid-2009.
The agreement with Capsugel follows the signature of an agreement for the commercial manufacture and supply of naproxcinod active pharmaceutical ingredient (API) with Archimica in March 2008. NicOx recently announced the results of the second pivotal phase 3 study for naproxcinod in patients with osteoarthritis of the knee (the 302 study, see NicOx press release of September 15th, 2008). This study met all three of its co-primary efficacy endpoints and supported naproxcinod's non-detrimental effect on blood pressure.
Staffan Stromberg, Vice President of Technical Development and Operations at NicOx, said: "We are very happy to have concluded this agreement with Capsugel, which is recognized as the world leader in capsule manufacturing. We believe Capsugel's flexibility and production capacity is well adapted to NicOx' launch preparations for naproxcinod. This agreement is also the result of the excellent collaboration between the two companies, in which Capsugel's technology has been used in the production of naproxcinod clinical trial supplies."
Under the terms of this exclusive agreement, Capsugel will be responsible for the formulation and encapsulation of naproxcinod API, using its patented LEMS(TM) technology (Liquid Encapsulation Microspray Sealing). The manufacturing will be performed at one of Capsugel's plants in France. A 2001 study showed that 66% of patients prefer to take drugs as capsules, compared to 22% who prefer tablets(1).
NicOx chose Capsugel as an exclusive supplier following a long-standing, fruitful collaboration, where Capsugel has been responsible for the manufacturing of naproxcinod capsules for clinical studies. Capsugel produced 160 billion capsules in 2007, giving it a 50% share of the capsule market. Its experience, expertise and capabilities make Capsugel the choice partner for the high-quality and efficient manufacture of naproxcinod capsules. Capsugel can bring to NicOx its expertise both in formulation and encapsulation due to its leading edge capsule manufacturing technology and formulation development capabilities.
"We are very pleased to continue our collaboration with NicOx through this agreement," commented Keith Hutchison, Vice President of Research and Development at Capsugel. "Naproxcinod is a new therapeutic approach addressing a huge market need and we believe this agreement represents an exciting opportunity for Capsugel. We are looking forward to leveraging our expertise to ensure substantial supplies of naproxcinod capsules and to be thus part of the expected success for this novel compound."
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 traditional Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and COX-2 inhibitors. The results of the third phase 3 trial for naproxcinod (the 303 study) are expected by the end of the year.
Capsugel is a division of Pfizer Inc. With a diverse product line, including hard gelatin, softgel, non-animal, and fish gelatin capsules, Capsugel is at the forefront of drug delivery innovation. As the leading global gelatin capsule manufacturer, Capsugel is the most experienced company in its field.
(1) Overgaard et al., "Patients' Evaluation of Shape, Size, and Color of Solid Dosage Forms", Pharmacy World and Science, 23 (5), 2001, 185-188.
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 of naproxcinod, a proprietary NCE and the first compound in the Cyclooxygenase-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, widespread eye diseases 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).
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
Director of Investor Relations
and Corporate Communication
Media in the United States
Media in Europe
Citigate Dewe Rogerson
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