Intercept Pharmaceuticals received approval from the U.S. FDA for their first orphan drug product, obeticholic acid, marketed in the U.S. as Ocaliva. The drug 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).

Global contract development and manufacturing organization (CDMO) Almac Group began supporting Intercept in 2013 during 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 and artwork of the now FDA approved drug product.

Intercept received accelerated FDA approval on Friday May 27, 2016, and utilizing Almac’s commercial Rapid Launch program, delivered from its Audubon, PA, commercial packaging facility, Ocaliva was packed and distributed on Tuesday May 31, 2016 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.

“Leveraging development and commercial teams, located both in the UK and U.S., illustrates Almac’s value proposition of service and team integration,” said David Downey, vice president commercial operations, Almac. “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, Intercept. “We look forward to a continued partnership as we prepare for the anticipated EU approval.”