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 March, 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- _______
For Immediate Release 15 March, 2007
SkyePharma PLC
Co-Promotion Agreement for Zileuton CR
LONDON, UK, 15 March 2007 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) notes that
its partner for zileuton CR, Critical Therapeutics (CTI), announced that it has
entered into a co-promotion agreement with DEY, L.P., an affiliate of Merck
KGaA.
The agreement means that a combined sales force of 240 representatives will be
available to promote zileuton CR, once it receives approval from the Food and
Drug Administration ("FDA"). The FDA is reviewing the New Drug Application
("NDA") for zileuton CR, which has a Prescription Drug User Fee Act (PDUFA) date
of May 31, 2007. Product launch is scheduled for the second half of 2007,
pending regulatory approval. Zileuton CR uses SkyePharma's proprietary GEOMATRIX
oral drug controlled release technology.
For further information please contact:
SkyePharma PLC +44 207 491 1777
Frank Condella, Chief Executive Officer
Ken Cunningham, Chief Operating Officer
Peter Grant, Finance Director
Buchanan Communications +44 207 466 5000
Tim Anderson / Mark Court / Rebecca Skye Dietrich
The Trout Group + 1 617 583 1308
Seth Lewis
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 nine 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 Critical Therapeutics
Critical Therapeutics, headquartered Lexington, MA, is developing and
commercializing innovative products for respiratory, inflammatory and critical
care diseases. The Company owns worldwide rights to ZYFLO(R) (zileuton tablets),
which is marketed in the United States for the prevention and chronic treatment
of asthma in patients 12 years of age and older. Critical Therapeutics is
working to expand its zileuton franchise by developing a twice daily,
controlled-release formulation for the prevention and chronic treatment of
asthma and an injectable formulation for acute asthma attacks that lead patients
to the emergency room and other urgent care settings. The Company also is
collaborating with MedImmune, Inc. to design antibody therapies that treat acute
and chronic diseases triggered by the inflammatory cytokine HMGB1. Research
pipeline programs include lifecycle management to extend the zileuton franchise
and an alpha-7 project for the treatment of inflammation. For more information,
please visit www.crtx.com.
About zileuton
Zileuton is a highly potent oral anti-inflammatory drug. It works by inhibiting
the enzyme 5-lipoxygenase. This enzyme, which is involved in the formation of
leukotrienes, is a key part of the inflammatory cascade that follows allergic
challenge. Inhibition of this enzyme therefore helps minimise
bronchoconstriction and mucus secretion in asthma. In its pivotal trials in
adult asthma, zileuton was shown to bring the greatest benefit to those with the
most severe disease. Zileuton is not intended for acute relief of asthma
symptoms but chronic treatment with zileuton allows reduction of other therapies
such as oral steroids which have undesirable side-effects.
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.
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: March 15, 2007