Almac Group, the global contract development and manufacturing organisation, wishes to congratulate its long-term client partner Intercept Pharmaceuticals, Inc. on the U.S. 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, 27th May 2016, and utilising Almac’s commercial Rapid Launch program, delivered from its Audubon, Pa. commercial packaging facility, Ocaliva was successfully packed and distributed on Tuesday, 31st 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 authorisation, 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 over a Memorial Day weekend. My congratulations to all those involved.”
“Our collaboration with Almac will help address the unmet need in PBC by bringing Ocaliva to U.S. 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.”
About Almac Group
‘Partnering to Advance Human Health’
The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,000 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).
For more information, visit www.almacgroup.com.