Hikma Pharmaceuticals Plc Regulatory Approval Colchicine (0840T)
September 30 2014 - 1:13PM
UK Regulatory
TIDMHIK
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(TM).
MITIGARE(TM) 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.
This information is provided by RNS
The company news service from the London Stock Exchange
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