Last checked at 21 Jul 2016 07:00
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."
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About Hikma
Hikma Pharmaceuticals PLC is a fast growing multinational group focused on developing, manufacturing and marketing a broad range of both branded and non-branded generic and in-licensed products. Hikma operates through three businesses: "Injectables", "Branded" and "Generics", based principally in the United States, the Middle East and North Africa (MENA) and Europe. In 2015, Hikma achieved revenues of $1,440 million and profit attributable to shareholders of $252 million.