Anticipated demand for the drug Exparel has led to a contract win for Patheon, though NDA holder Pacira says it will maintain control of all aspects of the manufacturing process.
From its own manufacturing suites at its Science Center Campus in San Diego, US, Pacira estimates it can currently produce $400m (€290m) worth of its non-opioid analgesic drug Exparel annually.
However, the firm told Outsourcing-Pharma.com expanded use of the drug in soft tissue and orthopaedic surgical procedures, as well as anticipated approval for additional indications has driven the need for greater capacity and Pacira has contracted Patheon to manufacture and package Exparel from its facility in Swindon, UK, once earmarked for closure .
“Our manufacturing facility in San Diego is capacity constrained,” the company said, adding it had been evaluating alternatives including the possible purchase of an existing sterile manufacturing facility.
“Ultimately, we chose to work with Patheon primarily because they have a sterile manufacturing facility with a good track record with the FDA,” Pacira continued.
“They are able to move rapidly with us to begin putting in place the additional capacity in two to three years so that we can stay ahead of anticipated demand, and they embraced our desire to maintain control of all aspects of our proprietary manufacturing know-how.”
The agreement will see a processing suite designed and built to mirror that of Pacira’s recently approved ‘Suite C’ manufacturing site at the San Diego facility , adding a further $300m of capacity for the drug, with Patheon setting aside further space for a second Exparel suite to be determined at a future date.
During a conference call in February to discuss end-of-year results (transcript here ), Pacira CEO Dave Stack said for the full year 2013 sales of Exparel grew 420% to $76m, compared to 2012, with Q4 revenue up 50% on the third quarter.
“We also saw 374 total new customers in the fourth quarter, a 27% increase from the previous quarter which translated to an average of 29 new customers per week,” he told investors. “As of the end of the year, 2106 distinct customers have ordered Exparel since launch.”
Though the firm told us “Patheon has experience in designing and building dedicated sterile manufacturing suites,” Pacira will be transferring its proprietary DepoFoam technology to the Swindon facility, along with key personnel to oversee the process.
The extended-release drug delivery technology platform is “a multivesicular liposomal platform that encapsulates drugs without altering their molecular structure and then releases them over a desired period of time from one to 30 days,” the company told us.
uses Pacira’s proprietary extended-release drug delivery technology DepoFoam – “a multivesicular liposomal platform that encapsulates drugs without altering their molecular structure and then releases them over a desired period of time from 1 to 30 days.”
Furthermore, the firm is confident of its growing place on the market, telling us not only is Exparel protected by a number of patents, Pacira is “currently the only company in the world with commercial scale manufacturing capability of multivesicularliposomes.”