23rd Apr 2007 08:00
Skyepharma PLC23 April 2007 Once-Daily REQUIP(TM) LP Extended-Release Tablets Approved in France LONDON, UK, Monday, April 23, 2007 - SkyePharma PLC (LSE:SKP; NASDAQ: SKYE)today announces that regulatory approval has been received in France forropinirole prolonged release tablets (which will be marketed as REQUIP(TM) LP(1) in France). The new prolonged release tablet of ropinirole is taken oncedaily, and is indicated for the treatment of Parkinson's disease (PD). SkyePharma's partner for the product, GlaxoSmithKline has also received approvalin Slovakia, Slovenia, Latvia, Estonia and Canada, and plans to gain furthermarketing authorisations in other countries. On 13 April, SkyePharma announced that the United States Food and DrugAdministration had accepted for filing the application by GSK for approval tomarket the product in the US. REQUIP(TM) LP has been designed to provide asteady rate of absorption in the body to help reduce blood plasma fluctuationsover 24 hours. Frank Condella, CEO of SkyePharma, commented: "We are pleased to announce theFrench approval of REQUIP(TM) LP, a significant step in the roll-out ofropinirole prolonged release tablets across the Continent. In the comingmonths, we expect to gain additional European approvals and will continue theroll-out of this important product across other member states of the EuropeanUnion." For further information please contact: SkyePharma PLC Frank Condella +44 20 7491 1777 Ken Cunningham Peter Grant Financial Dynamics (UK Enquiries) David Yates +44 20 7831 3113 Deborah Scott Trout Group (US Enquiries) Christine Labaree +1 617 583 1308 Seth Lewis NOTES TO EDITORS About Ropinirole Ropinirole is a non-ergot dopamine agonist currently marketed as REQUIP(R)(ropinirole HCl) Tablets, an immediate-release formulation. It has an indicationin the U.S. for the treatment of the signs and symptoms of idiopathicParkinson's disease and is administered three times a day. REQUIP(TM) LP usesSkyePharma's proprietary Geomatrix(TM) technology and has been designed to begiven once daily and to have a simpler and faster titration schedule. Our partner GSK conducted two pivotal studies to support of the registration ofropinirole prolonged release tablets in Europe. One study was a ropinirolemonotherapy study in early PD, and the other was an adjunct study with levodopa(L-dopa) in advanced PD. These studies confirmed the efficacy of ropiniroleprolonged release tablets, in terms of symptomatic control to allow patients tocontinue their daily activities. About Parkinson's Disease Parkinson's disease is a chronic, progressive and debilitating neurologicalcondition that impairs the body's ability to move and balance. Researchers havedetermined that Parkinson's disease involves pathways in the brain responsiblefor motor control that are functioning improperly. Patients with Parkinson'sdisease experience a reduction in dopamine, a key chemical in the brain thatcommunicates messages about movement, resulting in the symptoms of Parkinson'sdisease. These symptoms may include bradykinesia (slower-than-normal voluntarymovements), rigidity (stiffness), tremor (involuntary shaking) and posturalinstability (trouble with balance). In Europe, an estimated 800,000 people live with PD, with about 75,000 new casesdiagnosed every year.(i) The correct medication is key to helping them maintaina good quality of life and minimising long-term side effects. As with manydiseases, compliance is a significant barrier to positive patient outcomes inPD. 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 ten approved products in the areas of oral,inhalation and topical delivery that are marketed throughout the world byleading pharmaceutical companies. For more information, visit www.skyepharma.com About GlaxoSmithKline GlaxoSmithKline, with U.S. operations in Philadelphia and Research TrianglePark, N.C., is one of the world's leading research-based pharmaceutical andhealth care companies. 1. In the other member states of the European Union, the product suffixesunder consideration are REQUIP-MODUTAB(TM), REQUIP(TM) XL, or REQUIP DEPOT(TM).REQUIP, MODUTAB AND DEPOT are trademarks of the GlaxoSmithKline group ofcompanies. i European Federation of Pharmaceutical Industries and Associations: DiseaseBurden in Europe. http://www.efpia.org/Content/Default.asp?PageID=133 (AccessedApril 2007). This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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