Navigation Links
NicOx Signs Agreement With Capsugel for the Commercial Manufacture of Naproxcinod Oral Capsules

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.

About Capsugel

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 ( or on NicOx S.A.'s website (



Karl Hanks

Director of Investor Relations

and Corporate Communication

Tel +33-(0)4-97-24-53-42

Media in the United States


Robert Stanislaro

Tel +1-212-850-5657

Irma Gomez-Dib

Tel +1-212-850-5761

Media in Europe

Citigate Dewe Rogerson

David Dible

Tel +44-(0)207-282-2949

Nina Enegren

Tel +44-(0)207-282-1050

Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. NicOx Announces Departure of Damian Marron for CEO Position
2. NicOx Signs Agreement for the Commercial Manufacture of Naproxcinod Drug Substance
3. NicOx Initiates Two Large ABPM Studies for Naproxcinod in Hypertensive Patients with Osteoarthritis
4. NicOx to Present at Financial Conferences in New York on November 27, 28 and 29
5. NicOx Opens U.S. Headquarters in New Jersey
6. Martek Signs Multi-Year Sole-Source Supply Agreement With Hero
7. Assay Designs(TM), Inc. and the Spinal Muscular Atrophy Foundation Announce Collaboration To Accelerate the Discovery of New Therapeutics for Spinal Muscular Atrophy (SMA)
8. Sigma-Aldrich Signs Exclusive Agreement With IsoSciences, LLC, to Distribute Isotopically Labeled Bioactive Compounds
9. BioNeutral Signs Agreement With a Non-profit for Long-Term Removal of Formaldehyde to Save 10,000 Mobile Homes in Louisiana
10. Carna Biosciences Signs Reagent Supply Agreement with Caliper Life Sciences
11. Lumidigm Signs Strategic Agreement with Methode Electronics : Automotive Supplier Invests in Biometric Component Development
Post Your Comments:
(Date:11/27/2015)... , Nov. 27, 2015 /PRNewswire/--  Mallinckrodt plc (NYSE: ... today that it has closed the sale of its ... Guerbet (GBT- NYSE Euronext) in a transaction valued at ... manufacturing facilities and a total of approximately 1,000 employees ... St. Louis area. This entire ...
(Date:11/25/2015)... , November 26, 2015 ... Biobanking Market 2016 - 2020 report analyzes that ... integrity and quality in long-term samples, minimizing manual ... cost-effectiveness. Automation minimizes manual errors such as mislabeling ... efficiency. Further, it plays a vital role in ...
(Date:11/25/2015)... 25, 2015  Neurocrine Biosciences, Inc. (Nasdaq: NBIX ... and CEO of Neurocrine Biosciences, will be presenting at ... New York . .   ... approximately 5 minutes prior to the presentation to download ... presentation will be available on the website approximately one ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... uBiome, were featured on AngelList early in their initial angel funding process. Now, ... syndicate for individuals looking to make early stage investments in the microbiome space. ...
Breaking Biology Technology:
(Date:11/2/2015)... 2, 2015  SRI International has been awarded a ... development services to the National Cancer Institute (NCI) PREVENT ... scientific expertise, modern testing and support facilities, and analytical ... and toxicology studies to evaluate potential cancer prevention drugs. ... PREVENT Cancer Drug Development Program is an NCI-supported pipeline ...
(Date:10/29/2015)... Calif. , Oct. 29, 2015  The J. ... new report titled, "DNA Synthesis and Biosecurity: Lessons Learned ... the Department of Health and Human Services guidance for ... in 2010. --> ... it also has the potential to pose unique biosecurity ...
(Date:10/29/2015)... , Oct. 29, 2015  Rubicon Genomics, Inc., ... U.S. distribution of its DNA library preparation products, ... Rubicon,s new ThruPLEX Plasma-seq kit. ThruPLEX Plasma-seq has ... preparation of NGS libraries for liquid biopsies--the analysis ... and prognostic applications in cancer and other conditions. ...
Breaking Biology News(10 mins):