Novartis Joint Development
02 Dezembro 2003 - 5:00AM
UK Regulatory
RNS Number:7219S
Skyepharma PLC
02 December 2003
For Immediate Release 2 December, 2003
SKYEPHARMA PLANS JOINT DEVELOPMENT WITH NOVARTIS OF NEW PRODUCT FOR
TREATMENT OF ASTHMA AND COPD
LONDON, UK, 2 December 2003 -- SkyePharma PLC (LSE: SKP, Nasdaq: SKYE) today
announced an agreement with Novartis Pharma AG to jointly develop a new product
for the treatment of asthma and chronic obstructive pulmonary disease (COPD).
The product will combine Novartis' novel long-acting bronchodilator QAB149 with
two SkyePharma technologies:
* SkyeHalerTM, a breath-activated multi-dose dry powder inhaler (MDDPI)
device, to be marketed by Novartis as the CertihalerTM
* SkyeProtect(R), a powder formulation that protects the drug from
atmospheric moisture to ensure product stability and dose-to-dose
reproducibility
The product has already successfully completed a technical feasibility study at
SkyePharma. Novartis will make an initial payment to SkyePharma on signature of
the agreement. If the co-development project progresses successfully, Novartis
will also make future payments on attainment of development milestones and will
pay SkyePharma royalties on eventual sales.
Michael Ashton, chief executive of SkyePharma, said: "We are delighted by the
decision of Novartis to select our formulation expertise and SkyeHalerTM
technology for this exciting new compound. This agreement further confirms our
position as a leader in the development of products for the important and
fast-growing respiratory market."
Patients with asthma and COPD use bronchodilators to open the airways in the
lung, thereby improving their ability to breathe. Most bronchodilators are
short-acting but in recent years long-acting bronchodilators have been
introduced that have an extended duration of action and only need to be taken
twice a day. QAB149 is a long-acting bronchodilator that is currently in Phase
II trials for asthma. QAB149 was reviewed at the Novartis R&D Day on 19 November
2003 (for details, see www.novartis.com and use the internal search tool for
QAB149).
An agreement has already been made to use SkyePharma MDDPI and formulation
technology with Novartis' long-acting bronchodilator Foradil(R) (formoterol
fumarate). Foradil(R) CertihalerTM was co-developed by SkyePharma and
Novartis and was submitted for regulatory review in the US and Europe in
December 2002. In October 2003 the US Food and Drug Administration (FDA) issued
an "approvable" letter for Foradil(R) CertihalerTM, meaning that the product
can be approved by the FDA subject to resolution of certain outstanding issues.
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.
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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