29th Nov 2011 12:16
FDA Accepts Lodotra® New Drug Application for Review
Review Scheduled to be Completed in H2 2012
LONDON, UK, 29 November, 2011 – SkyePharma PLC (LSE: SKP) today announces that the United States Food and Drug Administration (“FDA”) has accepted for filing and review the New Drug Application for Lodotra® submitted by its licensee, Horizon Pharma, Inc. (“Horizon”) for the treatment of rheumatoid arthritis (“RA”).
The FDA has set a Prescription Drug User Fee Act (“PDUFA”) date, when the review is scheduled to be completed, of 26th July 2012 based on the standard 10 month review. Lodotra® is currently approved for marketing in 16 European countries.
Lodotra® utilises SkyePharma’s Geoclock™ technology to provide a proprietary delayed-release formulation of low-dose prednisone. Prednisone is currently FDA-approved for RA and commonly used to inhibit the production of various pro-inflammatory cytokines, which are proteins associated with joint inflammation in RA.
SkyePharma is entitled to a low-mid single digit percentage royalty on net sales of Lodotra® in North America and a mid-single digit percentage royalty elsewhere. Lodotra® is manufactured at the Lyon Manufacturing Facility recently leased by the Group to Aenova.
Axel Müller, Chief Executive Officer, SkyePharma, said: “Following the approval of Exparel in the US in October, today’s news is another milestone for SkyePharma and is further validation of our proprietary technology platform. The Company’s Geomatrix™ and Geoclock™ technologies enable controlled- or timed-release versions of immediate-release products to be developed providing advantages to both partner companies and patients.”
For further information please contact:
SkyePharma PLC |
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Axel Müller, Chief Executive Officer | +44 207 881 0524 |
Peter Grant, Chief Financial Officer |
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FTI Consulting |
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Jonathan Birt /Sue Quigley | +44 207 831 3113 |
About SkyePharma PLC
Using its proprietary drug delivery technologies, SkyePharma develops new formulations of known molecules to provide a clinical advantage and life-cycle extension. The Group has twelve approved products in the areas of oral, inhalation and topical delivery. 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 Lodotra®
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 rheumatoid arthritis 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.
