Another plant bites the dust

The active pharmaceutical ingredient (API) plant in Sandwich, Kent is the latest casualty in Pfizer's swathe of cost-cutting, due to be down-scaled over the next two years before its eventual closure with the loss of 420 jobs. The plant currently produces 5 tons of API each week, manufacturing the active ingredients for Pfizer products including antifungal treatments Diflucan (flucanazole) and Vfend (vorinconazole), each of which generated over $200m (€145m) during H1 2007. The production of these ingredients, along with other materials used in some of Pfizer's animal health products, will now be distributed among the company's other manufacturing sites, though a spokesperson for the firm was unable to provide details on which facilities would take over production. Along with the manufacturing capacity at the Sandwich facility, Pfizer also plans to close down the bioprocess development group at the site, responsible for developing new processes for biological manufacture of pharmaceuticals, as well as another group developing new technologies to improve process understanding and control. The only activities that will remain at Sandwich will be the well-established R&D group (responsible for discovering blockbuster drug Viagra (sildenafil citrate) among others), along with a small 10-15 person team who will work on APIs to support development of regulatory starting materials, says the company. Employees currently working in production at the site will be redeployed where possible, perhaps within the 3,000-person strong R&D unit at the site, according to the Pfizer spokesperson, though other manufacturing positions with the company in the UK are now essentially non-existent. The Sandwich plant was the target of manufacturing downscaling at Pfizer back in 2005, although at the time the company intended to maintain a production presence at the site. Not so fortunate was the company's production site in Morpeth, Northumberland, which was sold off to Indian contract manufacturer Nicholas Piramal in June 2006. Although the company does still operate a UK facility in Corby, Northamptonshire, this too is due to close by the end of 2008. Pfizer announced a major restructuring effort at the start of this year, slicing its workforce by 10 per cent (10,000 positions) and warning that a number of manufacturing and R&D sites would be closed down in a bid to establish a smaller and more flexible cost-base. In February came the news that the company was trimming its API manufacturing operations over in Ireland, with part of a site in Ringaskiddy being closed by the end of year, and two additional API sites being completely phased out over the next two years. This was particularly noteworthy as one of these sites had recently benefited from a $90m investment as the intended site for the production of Pfizer's hotly touted cholesterol drug torcetrapib. When in December the company was forced to terminate all clinical trials of the drug following an "imbalance of mortality and cardiovascular events​," the vast sum of money invested in drug development and production facilities was essentially written off. Combine this massive disappointment with imminent patent expiries and generic competition (particularly for blockbuster drug Lipitor (atorvastatin) due to start losing patent protection in 2010), and it is not surprising that Pfizer is tightening the purse strings and looking to cut API manufacturing by over 40 per cent as well as reduce its global plant network by 50 per cent over a four-year period. Contamination threat ​ To further compound Pfizer's worries, is the fact that its HIV drug Viracept (nelfinavir) is looking like it could potentially cause the company some serious grief thanks to the identification of a carcinogenic compound in the medication. A product of the manufacturing process, this toxic compound (ethyl mesylate or EMS) was the reason Roche's version of the drug was recalled across the EU a few months ago, and why the Swiss firm lost marketing authorisation for the antiretroviral therapy. Response to the contamination has been somewhat more intense on this side of the Atlantic where Roche is responsible for the drug. All patients have been switched to alternative medication, manufacturing has been suspended and the company is compiling registries of patients stretching back 10 years as well as carrying out studies to determine how harmful EMS can be. The recall alone has already cost the company €70m. In the US, however, where Pfizer is responsible for manufacturing and distribution of the drug, the reaction has been much more sedate. The only restrictions the company has placed on use of the drug is to recommend that no children or pregnant women needing to begin HIV treatment be prescribed Viracept, and any pregnant women currently on the drug should be switched to an alternative therapy if possible. The company has conferred with the US Food and Drug Administration (FDA), with the two organisations establishing acceptable interim and long-term levels of EMS in the drug. Aside from these precautions, all patients in the US are being encouraged to continue taking their Viracept treatment as normal. Whether Roche has overreacted to the contamination or Pfizer has responded inadequately will perhaps not become apparent until results from studies clarifying the risk to humans from EMS have been presented. However, Pfizer will presumably keeping a close eye on events over in Europe, and hoping that Viracept does not escalate into a Vioxx-esque affair. More details on Pfizer's Viracept contamination case can be found here​, with links to coverage of the Roche case here​. ​