RNS Number:1480U
Skyepharma PLC
13 January 2004


For Immediate Release:                                         13 January, 2004



 SkyePharma and Critical Therapeutics to develop controlled release formulation
                        for treatment of asthma and COPD



LONDON, UK, 13 January 2004 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) announces
an agreement with Critical Therapeutics Inc ("CTI"), a privately-held US
company, to develop a controlled-release formulation of the oral asthma drug
zileuton for asthma and chronic obstructive pulmonary disease ("COPD"). A four
times a day immediate-release version of zileuton was marketed by Abbott
Laboratories as Zyflo(R) Filmtab(R) (zileuton tablets).  SkyePharma developed a
controlled-release formulation of zileuton, using its Geomatrix(TM) technology.
Abbott has completed Phase III development in asthma with this product.



SkyePharma will collaborate with CTI on the further development of this
formulation for the indications of moderate to severe asthma and chronic
obstructive pulmonary disease (COPD). Once approved by the FDA, CTI will market
this product in the US through its own specialist salesforce. CTI will reimburse
SkyePharma for its development costs and SkyePharma will receive a royalty on
CTI's sales of zileuton and will also manufacture the product for CTI at its
plant in Lyon, France. Skyepharma received an unspecified milestone payment on
signature and will receive additional milestone payments on achievement of
various technical and commercial targets.



Michael Ashton, Chief Executive of SkyePharma, said: "We are delighted that CTI
has decided to take this project forward. CTI shares our view that there is
considerable untapped potential in this controlled release formulation of
zileuton, particularly for asthma and COPD, currently areas of significant unmet
medical need. We look forward to working with CTI on this additional application
of our Geomatrix technology.  For the avoidance of doubt, this is a new
agreement and is not one of the three major deals mentioned in our recent
trading update as being still under negotiation."



Paul Rubin MD, CTI's Chief Executive, said: "This agreement provides us with the
potential of near-term revenue from a product that has already completed a Phase
III program. We see an opportunity to broaden the use of zileuton through new
indications and new formulations."



Zileuton is an oral inhibitor of the enzyme 5-lipoxygenase, thereby blocking
formation of leukotrienes and so controlling a key part of the inflammatory
cascade that follows allergic challenge and leads to bronchoconstriction and
mucus secretion. Chronic use of zileuton may allow reduction of other therapies,
such as the use of b-agonists and oral or inhaled steroids, which have
undesirable side-effects.



The labelling approved by the US Food and Drug Administration ("FDA") for 
Zyflo(R) Filmtab(R) (zileuton tablets) indicated that it is not for use in the
reversal of acute asthma attacks.  Patients with active liver disease should not
take Zyflo.  Liver function tests are recommended prior to and during treatment
with Zyflo. When taking Zyflo, theophylline dose should be reduced by 50% and
appropriately monitored; patients taking propranolol or warfarin should be
monitored and doses adjusted if necessary.  The only adverse event reported
significantly more often by Zyflo patients than placebo-treated patients was
upset stomach (8.2% vs. 2.9%, respectively).



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 nine approved products incorporating three of
SkyePharma's five 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 privately held 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.criticaltherapeutics.com.



Except for the historical information herein, the matters discussed in this news
release include forward-looking statements that may involve a number of risks
and uncertainties. Actual results may vary significantly based upon a number of
factors, which are described in SkyePharma's 20-F and other documents on file
with the SEC. These include without limitation risks in obtaining and
maintaining regulatory approval for existing, new or expanded indications for
its products, other regulatory risks, risks relating to SkyePharma's ability to
manufacture pharmaceutical products on a large scale, risks that customer
inventory will be greater than previously thought, risks concerning SkyePharma's
ability to manage growth, market a pharmaceutical product on a large scale and
integrate and manage an internal sales and marketing organization and maintain
or expand sales and market share for its products, risks relating to the ability
to ensure regulatory compliance, risks related to the research, development and
regulatory approval of new pharmaceutical products, risks related to research
and development costs and capabilities, market acceptance of and continuing
demand for SkyePharma's products and the impact of increased competition, risks
associated with anticipated top and bottom line growth and the possibility that
upside potential will not be achieved, competitive products and pricing, and
risks associated with the ownership and use of intellectual property rights.
SkyePharma undertakes no obligation to revise or update any such forward-looking
statement to reflect events or circumstances after the date of this release.



For further information please contact:
SkyePharma PLC                                                  +44 207 491 1777
Michael Ashton, 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




                      This information is provided by RNS
            The company news service from the London Stock Exchange
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