Capsugel gets commercial deal from NicOx
The aim of this deal is to ensure sufficient supplies of naproxcinod capsules to underpin its successful commercial launch, according to NicOx. Capsugel was also responsible for manufacturing supplies of the drug for clinical testing purposes.
The French firm is expecting to file a New Drug Application (NDA) for naproxcinod with the US Food and Drug Administration (FDA) sometime in mid-2009.
The latest accord with Capsugel follows the signature of an agreement for the commercial manufacture and supply of naproxcinod active pharmaceutical ingredient with Archimica in March.
Under the terms of this latest agreement, Capsugel will be responsible for the formulation and encapsulation of naproxcinod API, using its patented LEMS (Liquid Encapsulation Microspray Sealing) technology.
NicOx recently announced the results of the second pivotal Phase III study for naproxcinod in patients with osteoarthritis of the knee. The study met all three of its primary efficacy endpoints and also showed that the patients' mean blood pressure was stable over the course of the study.
That finding is particularly important as it supports the contention that naproxcinod does not cause an increase blood pressure over time, which could help differentiate the drug from other products used to treat chronic pain, such as traditional non- steroidal anti-inflammatory drugs (NSAIDs) and COX-2 inhibitors such as Pfizer’s Celebrex (celecoxib).
There is mounting evidence that NSAIDs can cause elevations in blood pressure in susceptible individuals. Naproxen itself – the compound from which naproxcinod is derived - carries a warning on its label that it can impair the effects of blood pressure-lowering drugs.
If regulators concur with that view and naproxcinod is approved with a strong claim it is likely to become a major new product in the osteoarthritis arena, potentially filling some of the gap left by the withdrawal of COX-2 inhibitors such as Merck & Co’s Vioxx (rofecoxib) from the market on safety grounds.
Analysts have suggested the drug could achieve upwards of $500m a year in sales, and maybe even $1bn, should NicOx be able to secure an agreement with a suitably-positioned marketing partner with global reach in the primary care sector. The company has said it hopes to close such a deal within the next 12 months.