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NicOx Signs Agreement With DSM for the Commercial Manufacture of Naproxcinod Drug Substance
Date:12/2/2008

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.

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