14th May 2007 13:30
Skyepharma PLC14 May 2007 SkyePharma and Sciele Pharma Announce Successful Completion of New Sular(R) Formulation Clinical Trial Programme Study Showed Bioequivalence LONDON, UK and ATLANTA, US, May 14, 2007 - SkyePharma PLC (LSE:SKP; NASDAQ:SKYE)and Sciele Pharma. Inc. (NASDAQ:SCRX) today announce the successful completionof the clinical trial programme for the new formulation of Sular(R), a calciumchannel blocking agent for the treatment of high blood pressure. The studyresults showed that the new Sular formulation is bioequivalent to Sciele'scurrently marketed Sular. The new Sular formulation utilizes SkyePharma'spatented GeomatrixTM technology, which is designed to provide a lower dose ofSular for each of its current doses. The data from this study will be combined with the results from the previousclinical trial in Sciele's new Sular formulation supplemental New DrugApplication (sNDA) filing. Sciele expects to file an sNDA with the U.S. Foodand Drug Administration by end of the second quarter of 2007. For further information please contact: SkyePharma PLC +44 20 7491 1777Frank Condella, CEOKen Cunningham COOPeter Grant Finance Director Financial Dynamics +44 20 7831 3113 (UK Enquiries)David Yates / Deborah Scott Trout Group +1 617 583 1308 (US Enquiries)Christine Labaree / Seth Lewis NOTES TO EDITORS About Sular Nisoldipine, the active ingredient in Sular(R), is an antihypertensive agentused to reduce blood pressure. It is estimated that 65 million Americans (nearlyone quarter of the population) currently have elevated blood pressure, arecognised risk factor for stroke and heart attacks, and this number isincreasing from demographic factors as the post-war 'Baby Boom' reaches middleage. 60% of those affected are diagnosed and receive treatment but only half ofthose treated attain treatment goals so there is a recognised opportunity forbetter treatments. Nisoldipine is a calcium channel blocker that preventscalcium from entering certain types of muscle cells. Because muscle cells needcalcium to contract, calcium channel blockers prevent the cells from contractingand cause them to relax. Nisoldipine selectively relaxes the muscles of smallarteries causing them to dilate but has little or no effect on muscles or theveins of the heart. Sular is a registered trademark of Sciele Pharma, Inc. 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 Sciele Pharma, Inc. Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketingand development of branded prescription products focused on Cardiovascular/Diabetes and Women's Health. The Company's Cardiovascular/Diabetes productstreat patients with high cholesterol, hypertension, high triglycerides, unstableangina and Type 2 diabetes, and its Women's Health products are designed toimprove the health and well-being of women and mothers and their babies. Foundedin 1992 and headquartered in Atlanta, Georgia, Sciele Pharma employs more than800 people. The Company's success is based on placing the needs of patientsfirst, improving health and quality of life, and implementing its businessplatform - an Entrepreneurial Spirit, Innovation, Speed of Execution,Simplicity, and Teamwork. 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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