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Skyepharma PLC (SKYE) - Re Agreement

3/31/2009 12:46:13 PM

LONDON--(Marketwire - March 31, 2009) -

SkyePharma PLC Lodotra™ Outlicensed by Nitec to Mundipharma in Europe LONDON, UK, 31 March -- SkyePharma PLC (LSE: SKP) notes the announcement earlier today by its partner Nitec Pharma AG ("Nitec") that an exclusive license has been granted to Mundipharma International Corporation Limited ("Mundipharma") for the distribution of Lodotra™ in Europe, excluding Germany and Austria which are licensed to Merck KGaA. SkyePharma will receive a mid-single digit percentage royalty on net sales and is manufacturing the product at its plant in Lyon, France. Using SkyePharma's proprietary Geoclock™ technology, Lodotra™, a novel delayed-release, low-dose prednisone tablet, was recommended for European regulatory approval for the treatment of rheumatoid arthritis and associated morning stiffness in January 2009. Germany was the reference member state for the Decentralised Procedure and Lodotra™ is now also considered approvable by the regulatory agencies of 14 other countries. Lodotra™ is expected to be launched in Germany within the next few weeks. Dr. Ken Cunningham, CEO of SkyePharma said, "We are delighted by this agreement between our two partners, Nitec and Mundipharma, for the out-licensing of Lodotra™ in the remaining 14 European countries due to approve the product under the Decentralised Procedure. Using SkyePharma's Geoclock™ release technology, we believe Lodotra™ is promising news for people suffering from the pain of rheumatoid arthritis and the related morning stiffness." For further information please contact: SkyePharma PLC Ken Cunningham +44 20 7491 1777 Peter Grant Financial Dynamics Jonathan Birt +44 20 7831 3113 Susan Quigley About SkyePharma PLC Using its proprietary drug delivery technologies, SkyePharma develops new formulations of existing products 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 About Lodotra™ Lodotra™ is a circadian cytokine modulator (CCM), which can be taken at bedtime. Lodotra™'s unique release mechanism releases the glucocorticoid prednisone during the night around 2am enabling suppression of the nocturnal proinflammatory cytokines. This results in an effective relief of the early morning symptoms of RA, in addition to the well established treatment effects of glucocorticoids. This information is provided by RNS The company news service from the London Stock Exchange END

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