28th Apr 2005 07:00
Skyepharma PLC28 April 2005 FOR IMMEDIATE RELEASE 28 April, 2005 SkyePharma PLC SkyePharma and GlaxoSmithKline Reach Agreement on Payment of Royalties for Paxil CR(TM) LONDON, ENGLAND, 28 April, 2005 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP)announces today that it has entered into an amendment agreement withGlaxoSmithKline ("GSK") in respect of Paxil CR(TM). Under the terms of theamendment agreement, GSK will make a one-time payment of approximately $10million. In addition, SkyePharma will also be entitled to an increase in theroyalty rate from 3% to 4% on actual net sales of Paxil CR(TM), with effect from4 March 2005. As GSK has been unable to supply Paxil CR(TM) in the US since 4March 2005, GSK has also agreed to pay SkyePharma the same level of royalty onGSK's budgeted sales of Paxil CR(TM) from 4 March 2005 while the product remainsoff the market, subject to other terms of the agreement. Michael Ashton, SkyePharma's Chief Executive, said: "The royalties from PaxilCR(TM) are currently the single most important income flow for SkyePharma. We aretherefore delighted that GSK has agreed to continue the royalty payment as ifsupply was maintained. We look forward to continuing our work together with GSKon this and other product collaborations." On 4 March 2005, the US Food & Drug Administration ("FDA") halted distributionof supplies of Paxil CR(TM) and another unrelated product at GSK's manufacturingplant at Cidra in Puerto Rico and distribution depots, thereby halting USdistribution of Paxil CR(TM). Both GSK and the FDA agreed at the time thatmanufacturing issues cited by the Agency posed no significant safety issue forpatients. GSK is working with the FDA to resolve these manufacturing issues asquickly as possible. For further information please contact: SkyePharma PLC +44 207 491 1777Michael Ashton, Chief Executive OfficerPeter Laing, Director of Corporate Communications +44 205 491 5124 Sandra Haughton, US Investor Relations +1 212 753 5780 Buchanan Communications +44 207 466 5000Tim Anderson / Mark Court Notes to Editors About SkyePharma SkyePharma PLC uses its world-leading drug delivery technology to developeasier-to-use and more effective formulations of drugs. The majority ofchallenges faced in the formulation and delivery of drugs can be addressed byone of the Company's proprietary technologies in the areas of oral, injectable,inhaled and topical delivery, supported by advanced solubilisation capabilities.For more information, visit www.skyepharma.com. About Paxil CR(TM) In March 1996, SkyePharma entered into a License Agreement with SmithKlineBeecham (now part of GlaxoSmithKline) for the development, manufacture andmarketing of a modified release version of Paxil(R)/Seroxat(R) (paroxetinehydrochloride) using a combination of SkyePharma's GeomatrixTM PositionedRelease and Zero Order systems. Paxil(R) is an FDA-approved antidepressant drugthat is currently marketed primarily in the United States and Europe (where itis known as Seroxat(R)) and is an immediate release formulation prescribed forcentral nervous system disorders. Paxil CR(TM) was approved by the FDA inFebruary 1999 for the treatment of depression. Subsequently Paxil CR(TM) has beenapproved by the FDA for four additional indications: panic disorder, thecontinuous treatment of Pre-Menstrual Dysphoric Disorder (PMDD), social anxietydisorder and the intermittent treatment of PMDD. Except for the historical information herein, the matters discussed in this newsrelease include forward-looking statements that may involve a number of risksand uncertainties. Actual results may vary significantly based upon a number offactors, which are described in SkyePharma's 20-F and other documents on filewith the SEC. These include without limitation risks in obtaining andmaintaining regulatory approval for existing, new or expanded indications forits products, other regulatory risks, risks relating to SkyePharma's ability tomanufacture pharmaceutical products on a large scale, risks that customerinventory will be greater than previously thought, risks concerning SkyePharma'sability to manage growth, SkyePharma's marketing partners' ability to market apharmaceutical product on a large scale and manage their sales and marketingorganisation and maintain or expand sales and market share for its products,risks relating to the ability to ensure regulatory compliance, risks related tothe research, development and regulatory approval of new pharmaceuticalproducts, risks related to research and development costs and capabilities,market acceptance of and continuing demand for SkyePharma's products and theimpact of increased competition, risks associated with anticipated top andbottom line growth and the possibility that upside potential will not beachieved, competitive products and pricing, and risks associated with theownership and use of intellectual property rights. SkyePharma undertakes noobligation to revise or update any such forward-looking statement to reflectevents or circumstances after the date of this release. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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