SKP.L Regulatory News (SKP)

22 Apr 2008 07:00

Skyepharma PLC22 April 2008 SkyePharma Announces Exclusive License Agreement with Kyorin for Development and Distribution of Flutiform(TM)in Japan LONDON, UK, 22 April, 2008 - SkyePharma PLC (LSE: SKP) today announces that ithas entered into an exclusive Development, Distribution and License Agreementfor Flutiform(TM), its lead development product for the treatment of asthma,with Kyorin Pharmaceutical Co., Ltd., a subsidiary of Kyorin Co., Ltd. forJapan. SkyePharma will receive signing, development and approval milestonesworth several millions of pounds plus a high mid-single digit royalty on sales. The development costs associated with obtaining approval for the Japanese marketwill largely be met by Kyorin, which is responsible for clinical trials andregulatory submissions. Development is expected to take several years. Kyorin already operates in the Japanese asthma market, which was worthapproximately US$945 million in 2006 and grew at a compound annual growth rateof 9% between 2002 and 2006, according to Datamonitor (July 2007 report "Commercial Insight: Asthma/COPD"). Kyorin and Banyu, a wholly owned subsidiaryof Merck & Co., in Japan, co-market montelukast sodium under the trademark,Kipres(R) and Singulair(R) respectively. Montelukast sodium is an oralleukotriene receptor antagonist used for the maintenance treatment of asthma andto relieve symptoms of seasonal allergies. Kyorin's sales force of 650representatives visits up to 9,000 respiratory specialists in Japan. SkyePharma's Chief Executive Officer, Frank Condella, said: "This agreement withKyorin completes our licensing of Flutiform(TM)for the three majorpharmaceutical markets: the USA, EU and Japan. Kyorin's focus on respiratorytherapy makes it an ideal partner for the distribution of Flutiform(TM)in Japanand their commitment to the development of Flutiform(TM)serves as furtherendorsement of the potential of this product. This is the second positiveannouncement on Flutiform in as many weeks and we expect to continue thismomentum with more news flow in the coming weeks and months, including data fromthe key Phase III clinical trials for the US and Europe for Flutiform(TM)" For further information please contact: SkyePharma PLC Frank Condella +44 20 7491 1777During office hours Ken Cunningham Peter Grant Financial Dynamics (UK Enquiries) David Yates +44 20 7831 3113Outside office hours Deborah Scott Trout Group (US Enquiries) Christine Labaree +1 617 583 1308 Seth Lewis About SkyePharma PLC Using its proprietary drug delivery technologies, SkyePharma develops newformulations of known molecules to provide a clinical advantage and life-cycleextension. The Company has twelve approved products in the areas of oral,inhalation and topical delivery. The Group's products are marketed throughoutthe world by leading pharmaceutical companies. For more information, visitwww.skyepharma.com About Kyorin Pharmaceutical Co., Ltd. Founded in 1923, Kyorin Pharmaceutical is a pharmaceutical company, a whollyowned subsidiary of Kyorin Co., Ltd. listed on the Tokyo Stock Exchange. Thecompany has committed itself to a franchise customer strategy focusing onrespiratory, ear-nose-throat and urology. The company believes that in-licensing Flutiform(TM)will increase its strength in the respiratory field andstrengthen its franchise customer strategy. About Flutiform(TM) Flutiform(TM)HFA-MDI is a fixed-dose combination of formoterol and fluticasonein a metered dose inhaler ('MDI'). The product incorporates a fast onset long-acting beta-agonist (formoterol) with the most commonly prescribed inhaledsteroid (fluticasone) in combination with an environmentally-friendly aerosolpropellant hydrofluoroalkane ("HFA") and is being developed for asthma.Flutiform(TM)is aimed at the market for combination steroid and long-actingbeta-agonist inhalers which is forecast to be approximately US$10 billionworldwide by 2010, which is when the Board expects Flutiform(TM)to be in themarket in both the USA and Europe. This information is provided by RNS The company news service from the London Stock Exchange