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UCB is a wee bit excited after the opening of its newly expanded Irish facility, which will manufacture the company's overactive bladder drug, anticipated to be launched within the next two years.
The Belgium-based pharmaceutical company has had to expand its 30-year-old Shannon facility in the lead up to the approval and launch of its new drug fesoterodine, recommended to be brand named Toviaz.
A novel antimuscarinic agent to treat overactive bladder (incontinence), fesoterodine was licensed exclusively to Pfizer for marketing in April 2006.
Now with a Pfizer backing, UCB anticipates demand for the drug to skyrocket and has had to meet forecast sales targets with the expansion of the Shannon fine chemicals plant.
The increased capacity and the company's investment in the project, which started about a year ago, was undisclosed.
"This new facility will enable the production of an important new drug here," UCB chief executive and chairman Dr Roch Doliveux said in a statement.
Fesoterodine has been developed by Schwarz Pharma, which is now part of the UCB Group.
The drug was approved in the EU earlier this year and the company anticipates a European launch in the third quarter of next year.
Fesoterodine is still waiting for US approval and is hinged on an earlier approvable letter requirement from the US Food and Drug Administration (FDA) which requested a plant inspection of the Shannon facility.
UCB anticipates the US launch of the drug will occur in the first quarter of 2009.
Construction of the facility will be completed by the end of this year and the plant will be operational in the first quarter of next year, which will be followed by the FDA inspection.
Fesoterodine will only be manufactured at the Irish plant, which also manufacturers a variety of other active pharmaceutical ingredients, mainly nitrates.
"With €815m investments worldwide in R&D in 2006 and the full integration of Schwarz Pharma, UCB is actively building the next generation biopharma leader," Doliveux said.
