Corporate, Product, Press Release

Regulatory approval of Hikma’s colchicine is upheld

London, 21 July 2016 – Hikma Pharmaceuticals PLC (Hikma) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, today confirms that the United States Court of Appeals for the District of Columbia Circuit affirmed an earlier decision of the United States District Court for the District of Columbia finding in favour of the US Food and Drug Administration (FDA) and Hikma.  The FDA’s regulatory approval of Hikma’s colchicine 0.6 mg capsule product was upheld.

The decision means that Hikma may continue marketing colchicine 0.6 mg capsules under the brand name Mitigare™, as well as its authorised generic.  According to IMS Health, sales of colchicine in the U.S. market were approximately $651 million for the 12 months ending May 2016. Said Darwazah, Chairman and CEO of Hikma said, "I am very pleased that Hikma can continue marketing its colchicine products in the U.S. market.”