The $24m (€20m) acquisition of Aptuit’s sterile injectable drug product formulation and clinical stage manufacturing in Glasgow, UK, has already closed while a $36m agreement to buy Aptuit’s solid-state and analytical chemistry services site in West Lafayette, Indiana is expected to close within 30 days.
The acquisition of Aptuit’s assets will “significantly expand” AMRI’s drug product development and aseptic manufacturing services and increase its customer base both in North America and Europe, where the CDMO has until now had little exposure, the firm said in a conference call Friday.
“A large proportion of [the Glasgow site’s] customers are from mainland Europe which is a whole new area for us that we haven’t had much exposure to,” CEO William Marth told stakeholders, “and we are able to bring our services to these customers.”
“We are well established with fill/finish and parenteral capabilities in North America but we want to extend our reach into mainland Europe as well.”
The 30,000 sq ft site in Glasgow boasts sterile clinical manufacturing capabilities, including a dedicated cytotoxic manufacturing suite, on top of pre-formulation, formulation and process development capacity.
Milton Boyer, VP of Parenterals, added the acquisition broadened the range of services that could be offered to existing customers in a similar way that the $110m acquisition last June of his former company Oso Biopharmaceuticals saw AMRI customers benefit from the new commercial-scale fill/finish site in Alberquerque, New Mexico, and Oso customers benefit from AMRI’s core services.
“What we saw with the acquisition of [Oso’s] Alberquerque site it automatically brought clients into Burlington [AMRI’s Massachusetts manufacturing site] and having Burlington brought clients into Alberquerque.
“We believe the same will happen now we have Glasgow and have additional capabilities specifically in the area of lyophilisation cycle development that will bring more customers to both sites.”
The West Lafayette site offers API and formulation development services and boasts 250 pharma and CMO customers.
Expanded service capabilities will boost AMRI’s competitive advantage, Boyer said, but Marth said another major advantage spoken about on the call was the firm’s regulatory standing in the sterile manufacturing environment which has been hit hard by GMP violations.
“For sterile injectables, the competitive landscape here in the United States has been somewhat limited, and even impacts Europe, but basically we have seen there are challenges finding suppliers due to all the regulatory actions that are out there.”
Years of regulatory issues led to recalls and shortages at one of the largest sterile injectable CMOs, Ben Venue Laboratories, which was shut down permanently at the end of 2013 by parent company Boehringer Ingelheim after failed remediation attempts.
However, AMRI itself has suffered from operational issues, having to resolve issues its newly acquired Alberquerque plant late last year following a deviation in a sterile manufacturing suite. Furthermore, the Burlington site was under an FDA warning letter from 2010 until November 2013, due to a number of aseptic cGMP violations.