Hikma Pharmaceuticals Plc Regulatory approval of Hikma's colchicine upheld
July 21 2016 - 2:00AM
RNS Non-Regulatory
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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