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 January, 2004
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: | 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® Filmtab® (zileuton tablets). SkyePharma developed a controlled-release formulation of zileuton, using its Geomatrix™
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 ß-agonists and oral or inhaled steroids, which have
undesirable side-effects.
The labelling approved by the US Food and Drug Administration ("FDA") for Zyflo® Filmtab® (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 | |||
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: January 13, 2004