Pfizer plant cleared by FDA to make NicOx drug
pharmafile | June 24, 2010 | News story | Manufacturing and Production | Capsugel, NicOx, Pfizer, manufacturing, naproxcinod
Pfizer subsidiary Capsugel has won approval from the US Food and Drug Administration for a manufacturing facility based in France that will be used to manufacture naproxcinod, NicOx’s candidate drug for osteoarthritis.
Capsugel, a specialist in capsule formulations, has been working with NicOx to develop the naproxcinod formulation which, if approved for marketing, will be made at the facility in Ploërmel.
The FDA’s pre-approval and Good Manufacturing Practice (GMP) inspection of Capsugel’s facility included an inspection of the Licaps drug delivery system used to make the liquid-filled naproxcinod capsules.
NicOx has been developing naproxcinod – a first-in-class cyclooxygenase-inhibiting nitric oxide donator (CINOD) – as an anti-inflammatory agent that offered good gastrointestinal tolerability and safety but does not raise blood pressure.
The company suffered a setback earlier this year, however, when it failed to get the backing of an FDA advisory committee for naproxcinod. The panel voted against approval and said NicOx needed to generate more safety and efficacy data for the product through larger, more comprehensive clinical trials.
At the time, NicOx chief executive Michel Garufi said the company was committed to investing whatever is required to bring naproxcinod to market. An FDA verdict is due next month.
Ploërmel is Capsugel’s first FDA-approved manufacturing facility for clinical and commercial materials supply.
Meanwhile, workers at another Capsugel facility in Bornem, Belgium, have returned to work after going on strike over their employment terms. The 300 workers took industrial action after rejecting a management offer of increased salary terms, longer notice periods and an additional day’s holiday after long service.
Unions accepted the offer but the facility workers were unimpressed, and voted to down tools earlier this month. A second vote has since been taken and, while 57% of workers voted to remain on strike, they did not achieve the two thirds majority needed to maintain the industrial action.
Phil Taylor
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