Successful resolution to US FDA warning letter

RNS Number : 8029D

Hikma Pharmaceuticals Plc

02 April 2014

 

Hikma announces successful resolution to US FDA warning letter at Eatontown facility

London, 2 April 2014 - Hikma Pharmaceuticals PLC ("Hikma") (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), the fast growing multinational pharmaceutical group, today announces that we have received a close-out letter from the US Food and Drug Administration ("US FDA") that lifts the warning letter received in February 2012 in respect of its Eatontown facility in New Jersey, which provides oral products for the US market.  This communication follows the US FDA's re-inspection of the facility in February 2014 to complete its evaluation of the corrective actions we have taken in response to the warning letter.  This successfully resolves all issues raised by the US FDA in February 2012 and all subsequent communications.

Said Darwazah, Chief Executive Officer of Hikma commented:

"I am pleased to report that we have brought the Eatontown facility back into compliance with the US FDA.  The investment we have made to complete the remediation work, upgrade our manufacturing processes and strengthen our operations, provides greater quality and support for our customers and we are committed to continuing to invest in the highest quality standards.  We are gradually re-introducing products to the US market from the Eatontown facility, adding to the products we supply from our US FDA approved facilities in Jordan and Saudi Arabia.  We believe there are an increasing number of attractive market opportunities for our Generics business and we are investing in our pipeline of oral and other non-injectable product forms, whilst continuing to look for further product acquisition opportunities."

We expect the Generics business to deliver revenue of around $170 million in 2014, with an adjusted operating margin of above 25%.

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Enquiries

Hikma Pharmaceuticals PLC                                                       

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

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

FTI Consulting                                                                                  

Ben Atwell/ Matthew Cole/ Julia Phillips                                              [phone]

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. 

 

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