NicOx and Capsugel in manufacture of naproxcinod oral capsules

Biopharmaceutical company NicOx S.A, headquartered in France, has signed an exclusive agreement with global gelatin capsule manufacturer Capsugel for the commercial production and global supply of naproxcinod capsules.

Naproxcinod is NicOx's lead investigational product and the first compound in the Cyclooxygenase-Inhibiting Nitric Oxide-Donating (CINOD) class of anti-inflammatory agents.

Capsugel, a division of Pfizer, will be responsible for the formulation and encapsulation of naproxcinod API, using its patented LEMS (Liquid Encapsulation Microspray Sealing) technology. The manufacturing will be performed at one of Capsugel's plants in France.

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 US 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. This study met all three of its co-primary efficacy endpoints and supported naproxcinod's non-detrimental effect on blood pressure.

Staffan Stroemberg, vice president of technical development and operations at NicOx, said: "We are very happy to have concluded this agreement with Capsugel, which is recognised as the world leader in capsule manufacturing. We believe Capsugel's flexibility and production capacity is well adapted to NicOx's 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."

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 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.

Keith Hutchison, vice president of research and development at Capsugel, said: "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.

Reference

(1) Overgaard et al., "Patients' Evaluation of Shape, Size, and Color of Solid Dosage Forms", Pharmacy World and Science, 23 (5), 2001, 185-188.