DSM to make NicOx’ naproxcinod API
Under the deal, which brings NicOx' production agreement with Germany's Archimica to an end, DSM will make stocks of the active pharmaceutical ingredient (API) at its facility in Linz, Austria. The Dutch firm joins Capsugel, which was contracted to make commercial capsule supplies in September, as NicOx’ other significant partner.
NicOx’ director of investor relations, Karl Hanks, told in-PharmaTechnologist that DSM’s position as a global manufacturing leader and its experience working with major global drugmakers had been the key factors in winning it the contract.
He added that: “Our market research have predicted high sales for naproxcinod in the first years of its commercialisation. Therefore DSM will supply important quantities of naproxcinod API to ensure its successful launch.”
Hanks went on to say that NicOx plans to file naproxcinod with the US Food and Drug Administration (FDA) in mid 2009 and added that the firm’s “relationship with DSM is excellent and we do expect them to be involved in naproxcinod's API supply during and after the commercial launch.”
Last of the blockbusters?
As competition in the drug market grows and the era of personalised medicine dawns, NicOx’ is one of the few companies to still tout a product as a potential blockbuster. This confidence is leant credence by several factors.
Data from a recent Phase III trial showed that naproxcinod had achieved all of its primary efficacy and safety endpoints. Perhaps more importantly, the drug did not induce fluctuations in patient blood pressure during the study.
This is key given the mounting evidence that the non-steroidal anti-inflammatory agents (NSAID) that dominate the market, including the compound Naproxen from which naproxcinod is derived, can produce potentially harmful blood pressure elevations.
NicOx’ VP of technical development, Staffan Stromberg, said that: “The latest positive results…support our confidence in naproxcinod’s blockbuster potential.”
Analysts have generally agreed, predicting that naproxcinod will generate significant sales providing that NicOx finds appropriate support.
Robin Campbell, an analyst at Jefferies International told Bloomberg that: “The runway through to the filing with the US FDA looks clear. The only issue now is striking the right partnership deal.”
The company has said it hopes to close such a deal within the next 12 months.
