Intercept Pharmaceuticals received FDA approval of its first orphan drug product obeticholic acid, marketed as Ocaliva. Ocaliva was granted accelerated approval for the treatment of primary biliary cholangitis (PBC) 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).
 
Intercept began working with Almac in 2013 to support the early phase development of various dosage forms of Ocaliva. Almac’s commercial teams worked with Intercept for the commercial packaging including packaging design and artwork utilizing Almac’s commercial Rapid Launch program. Delivered from its Audubon, PA packaging facility, Ocaliva was successfully packed and distributed on May 31^st.
 
Almac will also support the anticipated EU launch of obeticolic acid, together with bulk drug product manufacture from its commercial manufacturing and packaging facility at its UK Headquarters in Craigavon, Northern Ireland.
 
David Downey, vice president of Almac’s Commercial Operations, said, “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.”