SkyePharma and AstraZeneca Announce Completion of Phase III Trials of HFA-MDI Version of Pulmicort(R)

SkyePharma and AstraZeneca Announce Completion of Phase III
Trials of HFA-MDI Version of Pulmicort(R) 


LONDON, July 8  /PRNewswire-FirstCall/ -- SkyePharma PLC (LSE:SKPLSE:Nasdaq:
SKYE) and AstraZeneca (LSE:AZ) today announce the completion of Phase III
trials of a new version of AstraZeneca's Pulmicort(R) (budesonide), an inhaled
corticosteroid for the treatment of asthma. The Metered Dose aerosol Inhaler
(MDI) uses a hydrofluoroalkane (HFA) propellant, replacing the
chlorofluorocarbon (CFC) propellant used in the currently marketed MDI version
of Pulmicort(R). CFCs are being withdrawn on environmental grounds because of
their potential to damage the ozone layer. However the replacement of CFC
propellants with HFAs can lead to substantial differences in MDI performance.
Pulmicort(R) HFA-MDI incorporates proprietary SkyePharma formulation technology
to ensure accurate and consistent delivery that matches the release profile of
the current version of Pulmicort(R) MDI.

Under the terms of agreements signed in December 2001, SkyePharma is
responsible for all pre-clinical and clinical development of Pulmicort(R) HFA-
MDI, as well as compiling regulatory filings for marketing approval in Europe.
AstraZeneca will pursue filing of the marketing application and following
approval will market Pulmicort(R) HFA-MDI in Europe and other non-US
territories. AstraZeneca is responsible for the commercial supply of the
product and has recently appointed Inyx, Inc. (OTC BB: IYXI) as contract
manufacturer responsible for scale-up activities and commercial production,
initially for a three year period.

A milestone will become payable to SkyePharma upon delivery of the final Phase
III Clinical Trial Reports and Stability Reports to AstraZeneca, expected in
the autumn. This is part of the total milestone payments of up to US$ 12
million due to SkyePharma under this agreement. In addition, SkyePharma will
receive royalties on net sales of Pulmicort(R) HFA-MDI.

Michael Ashton, Chief Executive of SkyePharma, said: "SkyePharma already has an
established presence in the important and fast-growing pulmonary delivery
market, with both breath-actuated dry-powder inhalers and metered- dose aerosol
inhalers that use non-CFC propellants. The completion of the Phase III trial of
the HFA-MDI version of Pulmicort(R) that we have developed for AstraZeneca is
an important milestone towards eventual commercialisation and also towards
validation of our MDI formulation technology."

   For further information please contact:
   SkyePharma PLC                                       [phone]
   Michael Ashton, Chief Executive Officer
   Peter Laing, Director of Corporate Communications    [phone]
   Sandra Haughton, US Investor Relations               [phone]
   Buchanan Communications                              [phone]
   Tim Anderson / Mark Court

  About SkyePharma


SkyePharma develops pharmaceutical products benefiting from world-leading drug
delivery technologies that provide easier-to-use and more effective drug
formulations. There are now ten 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
http://www.skyepharma.com/.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of prescription
pharmaceuticals and the supply of healthcare services. It is one of the world's
leading pharmaceutical companies with healthcare sales of over $18.8 billion
and leading positions in sales of gastrointestinal, oncology, cardiovascular,
neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones
Sustainability Index (Global and European) as well as the FTSE4Good Index. For
more information, visit http://www.astrazeneca.com/.

About Inyx

Inyx, Inc. is an emerging specialty pharmaceutical company with niche aerosol
drug delivery technologies and products. Inyx focuses its expertise on contract
manufacturing of prescription and over-the-counter pharmaceutical products, and
provides specialty pharmaceutical development and production consulting
services to the international healthcare market.

About Pulmicort(R)

Pulmicort(R) (budesonide) is an inhaled corticosteroid that is available in
about 90 countries for the treatment of asthma. Pulmicort(R) is also approved
in a number of countries for the treatment of chronic obstructive pulmonary
disease. First launched in 1981, it is available in both dry-powder inhaler and
metered-dose aerosol inhaler versions and also as Pulmicort Respules(R) for use
in nebulizers. In 2003 world sales were US$968 million.

About SkyePharma's pulmonary delivery technologies

SkyePharma is one of the leading independent providers of inhaled
pharmaceutical delivery technology. We can deliver pulmonary drugs either
though our own breath-actuated multi-dose dry powder inhaler or by metered-
dose aerosol inhalers powered by environmentally friendly hydrofluoroalkane
(HFA) propellants. These propellants replace the widely-used
chlorofluorocarbons (CFCs), now being phased out because of their potential to
damage the ozone layer. Our formulation capability ensures consistent and
accurate dose delivery even for hard-to-formulate materials.

SkyePharma has developed for Novartis Foradil(R) Certihaler(R), a multi- dose
dry powder inhaler version of Novartis' long-acting bronchodilator Foradil
(formoterol). SkyePharma developed not only the Skyehaler(TM) dry powder
inhaler device (to be marketed by Novartis as the Certihaler(R) for this
specific product) but also the formulation technology that ensures accurate and
consistent dosing. Foradil(R) Certihaler(R) has now received its first European
approvals and the US Food & Drug Administration issued an "approvable" letter
in October last year. SkyePharma has also entered into a second agreement with
Novartis to jointly develop a dry-powder inhaler version of QAB 149, Novartis'
novel long-acting bronchodilator. GlaxoSmithKline has also licensed
SkyePharma's formulation technologies for application to the delivery of
respiratory drugs, either by breath-actuated dry powder inhaler or by
metered-dose aerosol inhaler. SkyePharma has also demonstrated the successful
delivery of macromolecules with the SkyeHaler(TM) device.

SkyePharma is developing various pulmonary drugs in HFA metered-dose aerosol
inhalers. Apart from Pulmicort(R) HFA-MDI for AstraZeneca, these include the
bronchodilator formoterol (which has now completed Phase II development) and
the combination product Flutiform(TM), SkyePharma's proprietary fixed-dose
combination of formoterol with the inhaled corticosteroid fluticasone.

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. 

DATASOURCE: SkyePharma PLC



CONTACT:  Michael Ashton, Chief Executive Officer, or Peter Laing,

Director of Corporate Communications, [phone], Sandra Haughton, US

Investor Relations, [phone], all of SkyePharma PLC, [phone];

Tim Anderson or Mark Court, both of Buchanan Communications, [phone],

for SkyePharma PLC



Web site:  http://www.skyepharma.com/

http://www.astrazeneca.com/ 

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