Abbvie has expanded its API plant in Sligo, Ireland at which it produces trial supplies of more than half of its Phase III drug candidates.
When news of the €85m ($115m) expansion – which is expected to create 175 jobs - broke last week most reports characterised the plant as a production hub for Abbvie’s all-oral, interferon-free treatment for chronic hepatitis C.
However, while the active pharmaceutical ingredient (API) for the as yet unnamed hepatitis C treatment will be made at Sligo, the expanded facility will have wider role to play in Abbvie’s manufacturing operations according to spokesman Robert Lowe.
Lowe told in-Pharmatechnologist.com that: “The site in Sligo products more than 50 percent of our total Phase III pipeline products across a variety of therapeutic areas, including liver disease, oncology and women’s health.”
Abbvie’s Phase III pipeline includes: atrasentan for diabetic nephropathy; daclizumab for MS; the candidate Parkinson’s disease combination levodopa/carbidopa; elagolix for endometriosis; and elotuzumab, veliparib and ABT-199 for various cancer indications.
Hep C market
When Abbvie filed its candidate hepatitis C combination for review in the US in April and in Europe in May it included data from six Phase III trials showing that – after 12% weeks – it achieved a 99% response rate in patients with the tough to treat genotype 1 form of the virus.
Lowe confirmed that API for the product will be made at the Irish plant, explaining that “The site in Sligo is one of several across our network that will support AbbVie’s hepatitis C treatment. The expansion has increased the footprint of the site by 52%.
Low declined to say when regulators will decided whether or not to approve the new treatment, explaining that: “We are awaiting approval from regulatory bodies and will release the name of the treatment following anticipated approval.”
Approval would position Abbvie for a three-way fight with Gilead’s $1000-a-pill blockbuster Sovaldi, which the firm gained through the acquisition of Pharmasset in 2011, and Merck & Co which announced it will buy hepatitis C drug maker Idenix for $3.85bn.