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 October, 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 24 October, 2006
SkyePharma PLC
FDA accepts New Drug Application for zileuton CR
LONDON, ENGLAND, 24 October, 2006 -- SkyePharma PLC (LSE: SKP; NASDAQ: SKYE)
today announces that Critical Therapeutics, Inc (NASDAQ: CRTX) has recently
received acceptance from the FDA for its New Drug Application (NDA) for the
twice-daily, controlled-release formulation of zileuton (zileuton CR).
Zileuton CR is an investigational drug developed for the prevention and chronic
treatment of asthma in adults and children 12 years of age and older. Critical
Therapeutics (CRTX) submitted the NDA in late July and, pending regulatory
approval, expects to launch zileuton CR in the second half of 2007. The
anticipated PDUFA date is 31 May 2007.
Frank Condella, CEO, SkyePharma said:
"This is another important step in a successful collaboration and continued
validation of our GeomatrixTM technology. We look forward to the product
reaching the market, which we hope will begin to generate revenue in the next 12
months."
For further information please contact:
SkyePharma PLC +44 207 491 1777
Frank Condella, Chief Executive Officer
Ken Cunningham, Chief Operating Officer
Buchanan Communications +44 207 466 5000
Tim Anderson / Mark Court / Rebecca Skye Dietrich
The Trout Group + 1 617 583 1308
Seth Lewis
Notes for editors
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 eleven 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 the
discovery, development and commercialization of products for respiratory,
inflammatory and critical care diseases. The Company owns worldwide rights to
the asthma drug ZYFLO(R) (zileuton tablets), as well as other formulations of
zileuton. ZYFLO is the only 5-lipoxygenase inhibitor approved for marketing by
the U.S. Food and Drug Administration. The Company's commercialization efforts
for ZYFLO are carried out by its specialty sales force. Critical Therapeutics
also is developing treatments directed toward the severe inflammatory response
in acute diseases and conditions that lead to admission to the emergency room or
intensive care unit, and acute exacerbations of other chronic diseases that
frequently lead to hospitalization. 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/ Douglas Parkhill
Name: Douglas Parkhill
Title:
Company Secretary
Date: October 24, 2006