23rd Oct 2007 13:56
Skyepharma PLC23 October 2007 SkyePharma PLC Paxil CR(R) - Settlement between GSK and Mylan on Generic Launch LONDON, UK - 23 October, 2007 -- SkyePharma PLC (LSE: SKP) announces that MylanInc. (NYSE: MYL) and its subsidiary Mylan Pharmaceuticals Inc. have entered intoa patent license and settlement agreement with GlaxoSmithKline (LSE: GSK) ("GSK") relating to Paroxetine Hydrochloride (HCl) Extended-release (ER) Tablets, the generic version of GSK's Paxil CR(R). All litigation between Mylan and GSK relating to Paroxetine HCl ER Tablets has been dismissed. Mylan has reported that, under the agreement with GSK and an associated supplyand distribution agreement, Mylan is provided patent licenses and the right tomarket all three strengths of Paroxetine HCl ER Tablets, 12.5 mg, 25.0 mg and37.5 mg, beginning no later than 1 October, 2008. Mylan was the first companyto file an ANDA containing a paragraph IV certification covering the 12.5 mg and25.0 mg strengths. Upon receipt of final approval from the U.S. Food and DrugAdministration on 29 June, 2007, Mylan became eligible for a 180-day period ofmarketing exclusivity for these two tablet strengths. Paxil CRTM is an improved formulation of the anti-depressant Paxil(R) developedby SkyePharma with GSK using SkyePharma's GeomatrixTM technology. Sales of PaxilCRTM in the first half of 2007 were US$154 million. The majority of these saleswere in the US on which SkyePharma earned a royalty of 4%. -- ends -- For further information please contact: SkyePharma PLC Frank Condella, Chief Executive OfficerKen Cunningham, Chief Operating Officer +44 207 491 1777Peter Grant, Finance Director Financial Dynamics (London enquiries)David Yates / Deborah Scott +44 207 831 3113 Trout Group (US enquiries)Christine Labaree / Seth Lewis +1 617 583 1308 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 eleven 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. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
SKP.LGlaxosmithkline