PRESS RELEASE
Hikma receives approval for colchicine 0.6mg capsules
London, 30 September 2014 - Hikma Pharmaceuticals PLC ("Hikma") (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), the fast growing multinational pharmaceutical group, today announces the approval of its New Drug Application (NDA) for colchicine 0.6mg capsules by the US Food and Drug Administration (FDA). Hikma will market its colchicine under the brand name MITIGARE™.
MITIGARE™ is indicated for prophylaxis of gout flares in adults. This NDA has been approved under Section 505(b)(2) of the US Federal Food Drug and Cosmetic Act.
Said Darwazah, Chairman and CEO of Hikma, said, "This approval demonstrates our strong regulatory capabilities and the successful execution of our strategy to develop a more differentiated product portfolio for the US market."
According to IMS Health, sales of colchicine in the US market were approximately $688 million for the 12 months ending August 2014.
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Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal, VP Corporate Strategy and Director of Investor Relations +44 (0)20 7399 2760/
+44 7776 477050
Lucinda Henderson, Deputy Director of Investor Relations +44 (0)20 7399 2765/
+44 7818 060211
FTI Consulting +44 (0)20 7831 3113
Ben Atwell /Matthew Cole/ Julia Phillips
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: "Branded", "Injectables" and "Generics", based principally in the Middle East and North Africa ("MENA"), where it is a market leader, the United States and Europe. In 2013, Hikma achieved revenues of $1,365 million and profit attributable to shareholders of $212 million.
