Shire buys assets of SCM Pharma

Shire has acquired the trading assets of CDMO SCM Pharma, based in Northumberland, UK, after the company lost its cGMP licence at one of its UK plants.

SCM Pharma, which specialises in the sterile production of drugs destined for clinical trials, along with licensed medicines used by patients in niche markets, ran into difficulties in March after one of its manufacturing licences was withdrawn following a routine inspection at its Prudoe facility by the UK's MHRA (Medicines and Healthcare products Regulatory Agency).

The MHRA's GMP Non-Compliance Statement said that 'a critical deficiency was cited regarding potential product cross contamination, it was found that the company was manufacturing a potent cytotoxic (Amsacrine) product in the non-potent suite. Processes intended to contain the product had failed and cleaning process and verification were weak with contamination of general manufacturing areas seen.'

The firm had been working on a remediation plan but the cost implications had a heavy impact on the company, leading Shire Pharmaceuticals, its largest client, to step in.

Given the high costs associated with operating a complex manufacturing business, SCM Pharma did not have the funds to operate with limited manufacturing

SCM Pharma's founder and shareholder, Fiona Cruickshank, said: 'Following a scheduled inspection in March by the MHRA at the SCM Pharma site in Prudhoe, SCM Pharma voluntarily suspended selected manufacturing operations at the facility as a result of a critical observation made during the audit.

'Between March and 8 July, the non-executive team including myself at SCM Pharma worked tirelessly with the senior management team and the MHRA to address the issues at Prudhoe and agree a remediation plan.

'However, given the high costs associated with operating a complex manufacturing business, SCM Pharma did not have the funds to operate with limited manufacturing and also invest in the agreed remedial work required to address the issues raised.

'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.'

Although the company's Newburn site passed its MHRA inspection, Cruickshank decided to resign her position as Non-Executive Director and handed over the operational responsibility to a competent management team and Shire.

Cruickshank added: 'I am saddened to see that Shire decided to take the business into administration but hopefully the hard work of the non-executive directors over the last few months prior to my resignation will ultimately help safeguard many of the jobs that have been created over the last few years and ensure the sites can continue to supply medicines to patients, albeit under different ownership.'

Since hearing that Shire is planning no redundancies among the 80-strong workforce, Cruickshank said: 'I am pleased to hear our hard work has paid off and there are no planned redundancies as that was my main aim throughout the process.'

Shire said: 'The decision to place SCM Pharma Limited into administration was taken by SCM’s directors. Shire acquired assets from the administrators of SCM in order to continue manufacturing its product Buccolam, with a view to safeguarding the supply of Buccolam for its patients.'