NicOx signs agreement with DSM for the commercial manufacture of naproxcinod drug substance

Dec 3 2008

NicOx S.A. has 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.