Regulatory Approval Colchicine

RNS Number : 0840T

Hikma Pharmaceuticals Plc

30 September 2014

 



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.

-----  ENDS  -----

Enquiries

Hikma Pharmaceuticals PLC

Susan Ringdal, VP Corporate Strategy and Director of Investor Relations  [phone]/
[phone]

Lucinda Henderson, Deputy Director of Investor Relations                              [phone]/
[phone]

FTI Consulting                                                                                   [phone]

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. 

 

END

 

 

REALMMRTMBBJBBI