Skyepharma PLC Announces Regulatory Application


SkyePharma Announces Filing of New Drug Application
for FlutiformTM to the FDA


LONDON, UK, 23 March 2009 -- SkyePharma PLC ("SkyePharma" or the"Company")
(LSE: SKP) today announces the filing of a New Drug
Application ("NDA") for FlutiformTM (fluticasone propionate/formoterol
fumarate), SkyePharma's lead development product for the maintenance
treatment of asthma in patients 12 years of age and older, with the
U.S. Food and Drug Administration.

Primary endpoints were met in all of the clinical programmes required
for the submission of the NDA, comprising a long-term safety study and
four efficacy studies, covering nearly 2,300 patients.

FlutiformTM HFA-MDI is a fixed-dose combination of an inhaled
corticosteroid (ICS) fluticasone and formoterol, long-acting beta
agonist (LABA) in a metered dose inhaler.  ICS/LABA combinations are
the fastest growing segment of the global asthma/COPD market, which was
worth an estimated U.S. USD28.8 billion in 2007 globally.

Dr. Ken Cunningham, CEO of SkyePharma said, "The submission of the NDA
for FlutiformTM is a major milestone for SkyePharma.  We
believe that FlutiformTM, when approved, will provide physicians and
asthma patients with an additional treatment option to better manage
this serious, chronic condition."

SkyePharma will announce its results for the year ended 31
December 2008 on 26th March 2009.

For further information please contact:

SkyePharma PLC      Ken Cunningham  +44 20 7491 1777
                    Peter Grant

Financial Dynamics  David Yates     +44 20 7831 3113
                    Jonathan Birt


About SkyePharma PLC

Using its proprietary drug delivery technologies, SkyePharma develops
new formulations of existing products to provide a clinical advantage
and life-cycle extension. The Company has twelve 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.


About FlutiformTM

FlutiformTM HFA-MDI is a fixed-dose combination of fluticasone
and formoterol in a metered dose inhaler ("MDI"). The product
incorporates the most commonly prescribed inhaled anti-inflammatory
corticosteroid (fluticasone propionate) and a fast onset long-acting
beta-agonist (formoterol fumarate) in combination with an
environmentally-friendly aerosol propellant hydrofluoroalkane ("HFA")
and is being developed for asthma. FlutiformTM is licensed in
the U.S. to Abbott Respiratory LLC (formerly known as Kos Life
Sciences, Inc.), a wholly owned subsidiary of Abbott.


                    This information is provided by RNS
          The company news service from the London Stock Exchange

END

Contacts: RNS Customer Services 0044-207797-4400 Email Contact http://www.rns.com

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