In March 2014, inspectors from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) cited several violations in manufacturing processes at SCM Pharma’s facility in Prudhoe, Northumberland, leading to the withdrawal of its current GMP certification.
The contract development and manufacturing organisation (CDMO) had been working on a remediation plan, but Fiona Cruickshank – Owner and Non Exec Director until last month – said SCM “did not have the funds to operate with limited manufacturing and also invest in the agreed remedial work required to address the issues raised.”
Therefore, she continued: “Under the terms of its current loan agreement Shire informed us of its intention to exercise its step in rights as the company’s largest client.”
According to a source close to the matter who spoke to Outsourcing-pharma.com, SCM manufactures the drug Buccolam Oromucosal (Midazolam Hydrochloride) - a short-acting sedative used to treat seizures and insomnia and delivered orally - on behalf of ViroPharma (acquired by Shire for $4.2bn last year) from its nearby Newburn facility.
The Newburn plant received MHRA approval in June 2013, and was not affected by the inspection. Furthermore, the site has since passed a separate inspection after which Cruickshank handed over the reins to Shire.
However, two weeks ago the MHRA issued a voluntary recall of specific batches of ViroPharma’s Buccolam Oromucosal solution, following the inspection which identified the possibility for chemical contamination despite no evidence of contamination being found.
Cruickshank said she was “saddened” that Shire has chosen to take SCM into administration but remained confident the two sites would continue to supply drugs and retain jobs – approximately 80 – albeit under different owners.
Outsourcing-Pharma.com also spoke to Shire, who confirmed SCM Pharma had been under administration since August 5 and that it was working closely with the MHRA to transfer the current manufacturing assets into Shire’s name. "Shire has the licenses required to manufacture Buccolam going forward," spokesperson Jessica Cotrone told us, adding it would be "business as usual" for Buccolam production.
However, "Shire has no plans to enter into new contracts to manufacture products owned by other companies at SCM’s former site, and is not party to SCM Pharma Limited’s contracts," she added.
Shire is not the first sponsor to step in and take over operations at a third party manufacturing site. In December, Janssen began a six month lease of a facility owned by the now defunct Ben Venue Labs in order to ensure supply of the cancer drug Doxil, following several years of GMP issues at the CMO.