4th Oct 2006 07:01
Skyepharma PLC04 October 2006 For Immediate Release 4 October, 2006 SkyePharma PLC SkyePharma Reports Positive Phase III and EU Filing for Lodotra(TM) LONDON, ENGLAND, 4 October, 2006 -- SkyePharma PLC (LSE: SKP; Nasdaq: SKYE)today announces positive results of a Phase III clinical trial for Lodotra(TM),a new, modified-release tablet that has been developed in partnership with NitecPharma to optimize the efficacy of orally administered low-dose prednisone inRheumatoid Arthritis (RA). Lodotra uses SkyePharma's proprietary GEOCLOCK(TM)technology and has been filed with regulatory authorities in August by NitecPharma AG, which is a specialist pharmaceutical company focused on the treatmentof chronic inflammatory diseases. Lodotra provides all the benefits of standard immediate release (IR) prednisonebut has the additional, clinically important advantage of significantly reducingmorning symptoms combined with a convenient dosing regimen. The diurnal rhythm in RA is characterised by elevated night time levels ofinflammatory cytokines such as IL6, which leads to extreme stiffness and pain inthe hours immediately after waking. It has been established that these morningsymptoms can be addressed with prednisone administered at 2am. However, untilnow this has been impossible without disturbing sleep. Lodotra is an oralmedication that has a unique delivery system ensuring rapid release of theprednisone from the tablet core about 4 hours after ingestion. Administration ofLodotra at bed time results in a release of prednisone at about 2am for a moreeffective treatment of the morning symptoms of RA. The trial involved 288 patients in 26 centres in Europe, and was a randomized,double-blind, active-controlled, parallel-group Phase III study. The studycompared the efficacy and safety of Lodotra given to patients before sleep theevening before, with standard immediate-release (IR) prednisone (following thecurrent recommended regimen where prednisone is administered in the morning at8am) over a period of 12 weeks. The duration of morning stiffness (the primaryclinical endpoint of the study) was significantly reduced in the Lodotra groupwhile under standard IR prednisone no change in morning stiffness was shown. Inhalf the patients a reduction of more than one hour or one third was observedand those patients also showed a reduction in pain of one third. Lodotra wasalso shown to be well tolerated and just as safe as the standard regimen.Importantly, IL6 levels were shown to be reduced in the Lodotra group butremained constant in the standard prednisone group indicating that thisreformulation of prednisone was exerting a specific inhibitory action on what isthought to be a key biological marker of the inflammatory process in RA. Frank Condella, CEO, SkyePharma said: "We are extremely pleased with this validation of our GEOCLOCK(TM) technology inthis area of high unmet need, through these successful Phase III trials and thefiling in the EU. Lodotra(TM) should be the first commercial exploitation of ourGEOCLOCK(TM) technology which has the potential to be applied across a widerange of therapeutic needs." Prof. Frank Buttgereit, Charite Berlin; principal investigator in the studycommented: "These results confirm the hypothesis that the adaptation of the timing of oralglucocorticoids to the circadian rhythms in RA could lead to a more effectivetherapy without increasing the dose of prednisone. The benefit of Lodotraresults in a clinically relevant reduction of morning stiffness added to allknown therapeutic effects of IR prednisone. The new administration mode is alsoconvenient for the patient and was well tolerated." Jochen Mattis, co-founder and Head of Marketing of Nitec Pharma said: "We are delighted to have such positive results in a Phase III trial and havealready submitted a dossier for marketing authorisation in Europe in August. Wealso plan to seek marketing authorisation for North America and the Far East. Wewill also be seeking marketing partners to realise the commercial value ofLodotra worldwide, in addition to the agreement we already have with Merck KGaAin Germany and Austria." Lodotra has originally been developed through a partnership between SkyePharmaand Merck KGaA until 2004 when Nitec Pharma was spun out of Merck. For further information please contact: SkyePharma PLC +44 207 491 1777Frank Condella, Chief Executive Officer Buchanan Communications +44 207 466 5000Tim Anderson / Mark Court / Rebecca Skye Dietrich Notes for editors About SkyePharma SkyePharma PLC develops pharmaceutical products benefiting from world-leadingdrug delivery technologies that provide easier-to-use and more effective drugformulations. There are now twelve approved products incorporating SkyePharma'stechnologies in the areas of oral, injectable, inhaled and topical delivery,supported by advanced solubilisation capabilities. For more information, visitwww.skyepharma.com. About Nitec Pharma AG Nitec Pharma is a specialist pharmaceutical company created in 2004 in a spinout from Merck KGaA, financed by Atlas Venture and Global Life Science Ventures.Lodotra was originally developed by Merck in cooperation with SkyePharma usingSkyePharma's proprietary GEOCLOCK(TM) technology. Certain statements in this news release are forward-looking statements and aremade in reliance on the safe harbour provisions of the U.S. Private SecuritiesLitigation Act of 1995. Although SkyePharma believes that the expectationsreflected in these forward-looking statements are reasonable, it can give noassurance that these expectations will materialize. Because the expectations aresubject to risks and uncertainties, actual results may vary significantly fromthose expressed or implied by the forward-looking statements based upon a numberof factors, which are described in SkyePharma's 20-F and other documents on filewith the SEC. Factors that could cause differences between actual results andthose implied by the forward-looking statements contained in this news releaseinclude, without limitation, risks related to the development of new products,risks related to obtaining and maintaining regulatory approval for existing, newor expanded indications of existing and new products, risks related toSkyePharma's ability to manufacture products on a large scale or at all, risksrelated to SkyePharma's and its marketing partners' ability to market productson a large scale to maintain or expand market share in the face of changes incustomer requirements, competition and technological change, risks related toregulatory compliance, the risk of product liability claims, risks related tothe ownership and use of intellectual property, and risks related toSkyePharma's ability to manage growth. SkyePharma undertakes no obligation torevise or update any such forward-looking statement to reflect events orcircumstances 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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