SkyePharma Amends U.S. FlutiformTM Agreement
LONDON, UK, 20 December 2007 - SkyePharma PLC (LSE: SKP) today announces it has
revised the agreement with Abbott for the development and commercialization in
the United States of FlutiformTM, the Company's product under development for
the treatment of asthma. Under the terms of the amended agreement, Abbott
assumes the responsibility and costs for additional clinical work required and
agreed upon by the U.S. Food and Drug Administration (FDA) and submitting the
New Drug Application (NDA) for Flutiform.
SkyePharma's Chief Executive, Frank Condella, said, "We are very pleased to
announce this revised agreement. Abbott has been a very supportive partner
since acquiring Kos Pharmaceuticals, which had licensed the U.S. marketing and
distribution rights for Flutiform. We welcome Abbott's increased involvement in
the required additional clinical work and NDA filing, areas where they have
substantial expertise."
SkyePharma will no longer incur the planned research and development
expenditures of approximately US$20 million (£9.8 million) on the additional
Phase III FDA-required studies. In return for Abbott incurring the additional
costs on completing the development of Flutiform, SkyePharma has agreed to
reduced milestone payments due on the acceptance of filing and approval. Taking
this into account, together with the effects on milestones of the delay in
filing announced on 6 August 2007, SkyePharma may now receive up to US$124.5
million (£61 million) in total milestones instead of the previously stated
US$165.0 million (£80.9 million). Sales-related milestones and royalty rates
remain unchanged.
Abbott continues to be responsible for managing and funding any trials needed
for additional indications, as well as any required post-marketing studies. Once
approved by the FDA, Abbott retains its exclusive rights to market Flutiform in
the United States.
SkyePharma remains responsible for the existing Phase III clinical development
program costs, which comprises the completed safety study and three efficacy
trials that are on schedule to be completed by April 2008. Additionally,
SkyePharma continues to manage the Chemistry, Manufacture and Control program
and the supply chain for Flutiform.
FlutiformTM HFA-MDI
FlutiformTM HFA-MDI is a fixed-dose combination of formoterol and the inhaled
steroid fluticasone in a metered dose inhaler ('MDI'). The investigational
product incorporates a fast onset long-acting beta-agonist (formoterol) with the
most commonly prescribed steroid (fluticasone) in combination with an
environmentally friendly aerosol propellant ('HFA') and is being developed for
asthma. FlutiformTM is aimed at the market for combination steroid and
long-acting beta-agonist inhalers which is forecast to be approximately US$10
billion worldwide (including US$8 billion in the US) by 2010, which is when we
expect FlutiformTM to be in the market in both the US and Europe.
For further information please contact:
SkyePharma PLC Frank Condella +44 20 7491 1777
Ken Cunningham
Peter Grant
Financial Dynamics (UK Enquiries) David Yates +44 20 7831 3113
Deborah Scott
Trout Group (US Enquiries) Christine Labaree +1 617 583 1308
Seth Lewis
About SkyePharma PLC
Using its proprietary drug delivery technologies, SkyePharma develops new
formulations of known molecules to provide a clinical advantage and life-cycle
extension. The Company has eleven approved products in the areas of oral,
inhalation and topical delivery. The Group's products are marketed throughout
the world by leading pharmaceutical companies. For more information, visit
www.skyepharma.com
This information is provided by RNS
The company news service from the London Stock Exchange
SkyePharma PLC announces Re Agreement
| Source: SkyePharma PLC
London, UK--(Marketwire - December 20, 2007) -