Regulatory approval of Hikma's colchicine upheld

RNS Number : 7842E
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™, 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 and Investor Relations

+44 (0)20 7399 2760/ +44 7776 477050

 

Lucinda Baker, Deputy Director of Investor Relations

+44 (0)20 7399 2765/ +44 7818 060211

 

Zeena Murad, Investor Relations Manager

+44 (0)20 7399 2768/ +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. 

 


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