FDA 'Approvable' letter

RNS Number:1866R
Skyepharma PLC
22 October 2003


For immediate release                                                                               22 October, 2003



                                 SkyePharma PLC



        FORADIL(R) CERTIHALER(TM) RECEIVES "APPROVABLE" LETTER FROM FDA



LONDON, UK, 22 October 2003 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) announced
today that the US Food and Drug Administration ("FDA") has issued an "approvable
" letter for FORADIL(R) CERTIHALERTM (formoterol fumarate inhalation powder).
This means that the product can be approved by the FDA subject to resolution of
certain outstanding issues. The FORADIL CERTIHALER was co-developed by
SkyePharma PLC and Novartis Pharma AG. The FORADIL CERTIHALER was submitted for
regulatory review in the US in December 2002. FORADIL(R) CERTIHALERTM embodies
two proprietary SkyePharma technologies, the SKYEHALERTM, a novel
breath-activated multi-dose dry powder inhaler (MDDPI) device, and
SKYEPROTECTTM, a powder formulation that protects the drug from atmospheric
moisture to ensure product stability and dose-to-dose reproducibility.



Formoterol, the active ingredient in FORADIL(R) CERTIHALERTM , is a long-acting
beta-agonist bronchodilator, that combines a rapid onset of action (within1-3
minutes) with a long-lasting bronchodilation of 12 hours. This feature offers
large benefits for all patients who suffer from obstructive lung diseases.
Formoterol is licensed by Novartis Pharma AG from Yamanouchi Pharmaceuticals.
The CERTIHALERTM  dry-powder inhaler contains 60 doses giving patients the
convenience of 30 days of therapy in a single inhaler. This evolution of the
FORADIL(R) line was developed to provide a valuable and convenient option for
asthma patients who require maintenance therapy with a long-acting
bronchodilator.



Michael Ashton, SkyePharma's Chief Executive Officer commented "We are delighted
by the FDA's positive reaction to the FORADIL(R) CERTIHALERTM  submission.
Royalty income following ultimate approval of FORADIL(R) CERTIHALERTM will be
a key part of moving SkyePharma closer to its goal when the greater proportion
of our earnings will be derived from product-related revenues."



In October 2002, Schering-Plough (NYSE: SGP) obtained exclusive U.S.
distribution and marketing rights to all FORADIL(R) products from Novartis
Pharma AG. Schering-Plough currently markets FORADIL(R) AEROLIZERTM
(formoterol fumarate inhalation powder), a single-dose inhalation device.
Novartis Pharma AG retains international rights to the FORADIL(R) product line.
Approval of FORADIL(R) CERTIHALERTM  will trigger an undisclosed milestone
payment by Novartis to SkyePharma, which will also earn a royalty on all future
FORADIL(R) CERTIHALERTM sales. SkyePharma will also manufacture and supply
FORADIL(R) CERTIHALERTM.



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 from
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.



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                                               [phone]

Michael Ashton, Chief Executive Officer
Peter Laing, Director of Corporate Communications
Sandra Haughton, US Investor Relations                                       [phone]

Buchanan Communications                                                      [phone]
Tim Anderson / Mark Court




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