Hikma Announces Successful Resolution to US FDA Warning Letter at Eatontown Facility

Hikma Pharmaceuticals plc has received a close-out letter fromFDA 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 FDA’s re-inspection of the facility in February 2014 to complete its evaluation of the corrective actions the company has taken in response to the warning letter. This successfully resolves all issues raised by 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 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%.

www.hikma.com