Almac Group, the global contract development and manufacturing organization, wishes to congratulate its long-term client partner Intercept Pharmaceuticals on the US Food and Drug Administration (FDA) approval of their first orphan drug product obeticholic acid, marketed in the US as Ocaliva.
Ocaliva has been granted accelerated approval for the treatment of primary biliary cholangitis (PBC), previously known as primary biliary cirrhosis, in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
The partnership between Intercept and Almac commenced in 2013, with Almac’s Pharmaceutical Development teams supporting the early phase development of various dosage forms of Ocaliva. Building on this partnership, Almac’s commercial teams have worked with Intercept for the commercial packaging including packaging design & artwork of the now FDA approved drug product Ocaliva.
Intercept received accelerated FDA approval on Friday 27 May 2016 and, utilizing Almac’s commercial Rapid Launch programme, delivered from its Audubon (PA, USA) commercial packaging facility, Ocaliva was successfully packed and distributed on Tuesday 31 May after the Memorial Day holiday to Intercept’s specialty pharmacy network.
Almac will also support the anticipated EU launch of obeticolic acid if Intercept receives marketing authorization, together with bulk drug product manufacture from its commercial manufacturing and packaging facility at its UK Headquarters in Craigavon, Northern Ireland.
David Downey, VP Commercial Operations, commented: “Leveraging development and commercial teams, located both in the UK and US, illustrates Almac’s value proposition of service and team integration. This approach reduced lead time, mitigated risk and managed challenges, which led to a successful rapid launch within 48 hours of FDA approval during a Memorial Day weekend. My congratulations to all those involved.”
“Our collaboration with Almac will help to address the unmet need in PBC by bringing Ocaliva to US patients living with the disease,” said Richard Lancaster, Senior Director, Product Development at Intercept. “We look forward to a continued partnership as we prepare for the anticipated EU approval.”