London, UK -- (MARKET WIRE) -- May 14, 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 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 GeomatrixTM 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
(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®, 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 as 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.
This information is provided by RNS
The company news service from the London Stock Exchange