SKYEPHARMA PLC - RAYOS® (Lodotra®) RECEIVES APPROVAL IN U.S.

SKYEPHARMA PLC - RAYOS® (Lodotra®) RECEIVES APPROVAL IN U.S.

 Launch expected in Q4 2012

LONDON, UK, 27 July, 2012 - SkyePharma PLC (LSE: SKP) today announces that the United States Food and Drug Administration ("FDA") has approved the New Drug Application ("NDA") for RAYOS® (known as Lodotra® in Europe) for the treatment of a broad range of diseases including rheumatoid arthritis ("RA").  The NDA submitted by its licensee, Horizon Pharma, Inc. ("Horizon") was accepted for review on 29 November 2011.

The FDA approval was supported by data bridging the pharmacokinetics of RAYOS®/Lodotra® to immediate-release prednisone and data from the Circadian Administration of Prednisone in RA (CAPRA-1 and 2) trials.  The CAPRA-2 trial demonstrated that people with moderate to severe RA treated with RAYOS®/Lodotra® experienced a statistically significant improvement in the American College of Rheumatology 20 per cent response criteria (ACR20) compared with placebo.  Patients in the CAPRA-2 study also received disease-modifying anti-rheumatic (DMARD) therapy.  The CAPRA-1 trial supported the overall safety of RAYOS®/Lodotra®.  As Lodotra®, the product is also currently approved for marketing in 16 European countries as well as Israel.

RAYOS®/Lodotra® utilises SkyePharma's unique Geoclock™ technology to provide a proprietary delayed-release formulation of low-dose prednisone which is currently exclusively licensed to Horizon for use in RA.

SkyePharma is entitled to a low-mid single digit percentage royalty on net sales of RAYOS®/Lodotra® in North America and a mid single digit percentage royalty elsewhere.  RAYOS®/Lodotra® is manufactured at the Lyon Manufacturing Facility leased by SkyePharma to Aenova SAS (part of the Aenova Holding GmbH Group, a German-based pharmaceutical contract manufacturing organisation).

Peter Grant, Chief Executive Officer of SkyePharma, commented:

 "The approval of RAYOS in the United States is another milestone for SkyePharma and is further validation of our proprietary technology platforms.  The Group's Geomatrix™ and Geoclock™ technologies enable controlled- or timed-release versions of otherwise immediate-release products to be developed providing advantages to both partner companies and patients." 

 For further information please contact:

 

 

SkyePharma PLC

 

Peter Grant, Chief Executive Officer

+44 207 881 0524

FTI Consulting

 

Jonathan Birt/Julia Phillips/Susan Stuart

+44 207 831 3113

 About SkyePharma PLC

Using its multiple drug delivery technologies and expertise, SkyePharma creates enhanced versions of pharmaceutical products.  The Group receives revenues from thirteen approved products in the areas of inhalation, oral, topical and injectable delivery as well as generating income from the development of further products and technology licenses.  The Group's products are marketed throughout the world by leading pharmaceutical companies.  For more information, visit www.skyepharma.com

About Rheumatoid Arthritis ("RA")

RA is a chronic disease that causes pain, stiffness and swelling, primarily in the joints.  RA affects approximately 1.8 million people in the United States and is not associated with factors such as ageing.  RA occurs when the body's immune system malfunctions, attacking healthy tissue and causing inflammation, which leads to pain and swelling in the joints, and may eventually cause permanent joint damage and painful disability.  The primary symptoms of RA include progressive immobility and pain, especially in the morning, with long-term sufferers experiencing continual joint destruction for the remainder of their lives.

About RAYOS®/Lodotra®

RAYOS®/Lodotra®, is a novel programmed-release formulation of low dose prednisone, utilising SkyePharma's proprietary Geoclock™ technology and developed in collaboration with Horizon.  It was approved in Europe in March 2009, under the European decentralised procedure, for the treatment of moderate to severe active RA in adults particularly when accompanied by related morning stiffness.  It was launched in Germany in April 2009 and in Italy in January 2011.  Horizon has licensed to Mundipharma the distribution rights for Lodotra® in Europe as well as in Australia, China, Hong Kong, Indonesia, Korea, Malaysia, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand and Vietnam and in March 2012, this was extended to include Mexico, Brazil, Argentina, Colombia, Venezuela, Peru, Chile, Ecuador, Dominion Republic, Guatemala, Costa Rica, Uruguay, Bolivia, Panama, Nicaragua, El Salvador and Honduras. 

 

For further information on the CAPRA-1 and 2 trial please visit Horizon's website at: http://ir.horizon-pharma.com/releases.cfm.  Further information on the FDA approval and prescribing information for the United States is available at www.RAYOSrx.com.

 

 

 

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