Almac Group, a Northern Ireland-based contract development and manufacturing organization, will support the launch of Ocaliva (obeticholic acid), a liver-disease drug by Intercept Pharmaceuticals, a New York-based biopharmaceutical company, that received accelerated approval from the US Food and Drug Administration (FDA) in May 2016. The drug is used to treat primary biliary cholangitis in combination with ursodeoxycholic acid.

The partnership between Intercept and Almac started in 2013 when Almac supported the early-phase development of various dosage forms of Ocaliva. Almac has also worked with Intercept on the commercial packaging of the drug.

Following the FDA's approval in May 2016, Intercept used Almac's launch program to deliver Ocaliva from Almac's Audobon, Pennsylvania commercial packaging facility to its specialty pharmacy network. If Intercept receives marketing authorization for the drug in the European Union, Almac will also support launch of the product in that region, including providing bulk drug manufacturing at its manufacturing and packaging facility in Craigavon, Northern Ireland.

Source: Almac