Hikma Pharmaceuticals Plc Regulatory approval of Hikma's colchicine upheld

TIDMHIK

Hikma Pharmaceuticals Plc

21 July 2016

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(TM), 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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Enquiries

Hikma Pharmaceuticals PLC

 
 Susan Ringdal, VP Corporate Strategy    +44 (0)20 7399 2760/ 
  and Investor Relations                  +44 7776 477050 
 Lucinda Baker, Deputy Director          +44 (0)20 7399 2765/ 
  of Investor Relations                   +44 7818 060211 
 Zeena Murad, Investor Relations         +44 (0)20 7399 2768/ 
  Manager                                 +44 7771 665277

FTI Consulting

 
 Ben Atwell/ Matthew Cole    +44 (0)20 3727 1000

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.

This information is provided by RNS

The company news service from the London Stock Exchange

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July 21, 2016 02:00 ET (06:00 GMT)

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