SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a - 16 OR 15d - 16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the month of May, 2007
SkyePharma PLC
SkyePharma PLC, 105 Piccadilly, London W1J 7NJ England
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40F.
Form 20-F X Form 40-F
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes No X
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82- _______
SKYEPHARMA AND SCIELE PHARMA ANNOUNCES SUCCESSFUL COMPLETION OF
NEW SULAR® 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 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
(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.
END
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
SkyePharma PLC
By: /s/ John Murphy
Name: John Murphy
Title:
Company Secretary
Date: May 14, 2007