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 July, 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 8 July, 2004
SKYEPHARMA AND
ASTRAZENECA ANNOUNCE COMPLETION OF PHASE III
TRIALS OF HFA-MDI VERSION OF
PULMICORT®
LONDON, UK, 8 July 2004 --
SkyePharma PLC (LSE: SKP, Nasdaq: SKYE) and AstraZeneca (LSE:AZ) today announce
the completion of Phase III trials of a new version of AstraZeneca's
Pulmicort® (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®. CFCs are being withdrawn on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® HFA-MDI incorporates proprietary
SkyePharma formulation technology to ensure accurate and consistent delivery
that matches the release profile of the current version of Pulmicort® MDI.
Under the terms of agreements signed in December 2001, SkyePharma is responsible
for all pre-clinical and clinical development of Pulmicort® 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® 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® 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® 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 | +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 | |||
Notes for editors:
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
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 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®
Pulmicort® (budesonide) is an inhaled corticosteroid that is available in
about 90 countries for the treatment of asthma. Pulmicort® 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® 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® Certihaler®, a multi-dose
dry powder inhaler version of Novartis' long-acting bronchodilator Foradil
(formoterol). SkyePharma developed not only the Skyehaler™ dry powder inhaler
device (to be marketed by Novartis as the Certihaler® for this specific
product) but also the formulation technology that ensures accurate and
consistent dosing. Foradil® Certihaler® 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™device.
SkyePharma is developing various pulmonary drugs in HFA metered-dose aerosol
inhalers. Apart from Pulmicort® HFA-MDI for AstraZeneca, these include the
bronchodilator formoterol (which has now completed Phase II development) and the
combination product Flutiform™ , 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.
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: July 8, 2004