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 August, 2006
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 1 August, 2006
Critical Therapeutics Files Controlled
Release Formulation of Zileuton
LONDON, UK, 1 August 2006 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) announces that its partner Critical Therapeutics Inc ("CTI",
Nasdaq: CRTX) has submitted a New Drug Application to the US Food & Drug Administration for a controlled-release formulation of the
oral anti-inflammatory drug zileuton for asthma in adults and children aged 12 years or older. The new formulation only needs to be
taken twice a day whereas Zyflo®, the currently marketed version of zileuton, has the drawback of requiring dosing four times a day.
A four times a day immediate-release version of zileuton was marketed by Abbott Laboratories ("Abbott") as Zyflo® Filmtab® (zileuton
tablets). SkyePharma developed a controlled-release formulation of zileuton, using its Geomatrix™ technology, for Abbott, which
completed Phase III development in asthma with this product. CTI acquired the rights to zileuton from Abbott and since December 2003
SkyePharma has collaborated with CTI on the further development of this formulation. SkyePharma will receive a single-digit royalty
on CTI's sales of the controlled-release formulation of zileuton and will also manufacture the product for CTI at its plant in Lyon,
France.
Frank Condella, Chief Executive of SkyePharma, said: "We are pleased that this successful collaboration with CTI has now culminated
in the filing of this version of zileuton, another example of the power of our Geomatrix™ technology. Our partner expects this
product to reach the market in the second half of next year when it will become another source of royalty and manufacturing income
for SkyePharma."
For further information please contact:
SkyePharma PLC +44 207 491 1777
Frank Condella, Chief Executive Officer
Peter Laing, Director of Corporate Communications 44 207 491 5124
Sandra Haughton, US Investor Relations +1 212 753 5780
Buchanan Communications +44 207 466 5000
Tim Anderson / Mark Court / Rebecca Skye Dietrich
About SkyePharma
SkyePharma PLC develops pharmaceutical products benefiting from world-leading drug delivery technologies that provide easier-to-use
and more effective drug formulations. There are now twelve approved products incorporating SkyePharma's technologies in the areas of
oral, injectable, inhaled and topical delivery, supported by advanced solubilisation capabilities. For more information, visit
www.skyepharma.com.
About Critical Therapeutics
Critical Therapeutics, Inc. is a biopharmaceutical company focused on critical care medicine. CTI's mission is the discovery,
development and commercialization of novel therapies for the treatment of acute trauma, cardiopulmonary disease and infectious and
inflammatory illness. The Company is headquartered in Cambridge, Massachusetts. More information about CTI is available at
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/ Douglas Parkhill
Name: Douglas Parkhill
Title:
Company Secretary
Date: August 1, 2006