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 completion of the clinical trial programme
for the new formulation of Sular, a calcium
channel blocking agent for the treatment of high blood pressure. The study results showed that the new Sular formulation is bioequivalent to Sciele's currently marketed Sular. The new Sular formulation utilizes SkyePharma's patented Geomatrix technology, which is designed to provide a lower dose of Sular for each of its current doses.
The data from this study will be combined with the results from the previous clinical trial in Sciele's new Sular formulation supplemental New Drug Application (sNDA) filing. Sciele expects to file an sNDA with the U.S. Food and Drug Administration by end of the second quarter of 2007.
For further information please contact:
SkyePharma PLC +44 20 7491 1777
Frank Condella, CEO
Ken Cunningham COO
Peter Grant Finance Director
Financial Dynamics +44 20 7831 3113
David Yates / Deborah Scott
Trout Group +1 617 583 1308
Christine Labaree / Seth Lewis
Nisoldipine, the active ingredient in Sular(R), is an
antihypertensive agent used to reduce blood pressure. It is
estimated that 65 million Americans (nearly one quarter of the
population) currently have elevated blood pressure, a recognised
risk factor for stroke and heart attacks, and this number is
increasing from demographic factors a
s the post-war 'Baby Boom'
reaches middle age. 60% of those affected are diagnosed and receive
treatment but only half of those treated attain treatment goals so
there is a recognised opportunity for
better treatments. Nisoldipine is a calcium channel blocker that prevents calcium from entering certain types of muscle cells. Because muscle cells need calcium to contract, calcium channel blockers prevent the cells from contracting and cause them to relax. Nisoldipine selectively relaxes the muscles of small arteries causing them to dilate but has little or no effect on muscles or the veins of the heart.
Sular is a registered trademark of Sciele Pharma, Inc.
About SkyePharma PLC
Using its proprietary drug delivery technologies, SkyePharma
develops new formulations of known molecules to provide a clinical
advantage and life-cycle extension. The Company has ten approved
products in the areas of oral, inhalation and topical delivery that
are marketed throughout the world by leading pharmaceutical
companies. For more information, visit www.skyepharma.com
About Sciele Pharma, Inc.
Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on Cardiovascular/ Diabetes and Women's Health. The Company's Cardiovascular/Diabetes products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and Type 2 diabetes, and its Women's Health products are designed to improve the health and well-being of women and mothers and their babies. Founded in 1992 and headquartered in Atlanta, Georgia, Sciele Pharma employs more than 800 people. The Company's success is based on placing the needs of patients first, improving health and quality of life, and implementing its business platform - an Entrepreneurial Spirit, Innovation, Speed of Execution, Simplicity, and Teamwork .
Certain statements in this news release are forward-looking statements and are made in reliance on the safe harbour provisions of the U.S. Private Securities Litigation Act of 1995. Although SkyePharma believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurance that these expectations will materialize. Because the expectations are subject to risks and uncertainties, actual results may vary significantly from those expressed or implied by the forward-looking statements based upon a number of factors, which are described in SkyePharma's 20-F and other documents on file with the SEC. Factors that could cause differences between actual results and those implied by the forward-looking statements contained in this news release include, without limitation, risks related to the development of new products, risks related to obtaining and maintaining regulatory approval for existing, new or expanded indications of existing and new products, risks related to SkyePharma's ability to manufacture products on a large scale or at all, risks related to SkyePharma's and its marketing partners' ability to market products on a large scale to maintain or expand market share in the face of changes in customer requirements, competition and technological change, risks related to regulatory compliance, the risk of product liability claims, risks related to the ownership and use of intellectual property, and risks related to SkyePharma's ability to manage growth. SkyePharma undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.