SOURCE: SkyePharma PLC

January 21, 2010 10:59 ET

Skyepharma PLC announces - Regulatory Update

London, UK--(Marketwire - January 21, 2010) -


SKYEPHARMA PLC - FlutiformTM U.S. NDA Update


LONDON, UK, 21 January 2010 - SkyePharma PLC (LSE: SKP) today announces
the receipt of a Complete Response Letter from the U.S. Food and Drug
Administration (FDA) in respect of the New Drug Application (NDA)
for FlutiformTM (fluticasone propionate/formoterol fumarate), an
investigational treatment for persistent asthma in patients 12 years of
age and older. 


The FDA stated that it could not approve the NDA in its present
form and raised a number of substantive issues to be addressed, which,
if undertaken, would involve significant additional clinical work
including work to provide the additional data on dosing as previously
disclosed. 


Discussions will be sought with the FDA as soon as possible
to determine what steps would need to be taken before the application
can be approved.  Further information on the impact of the additional
work on timing and costs will be announced once clarification has been
obtained.


The review issues are not expected to have an impact upon the
development of FlutiformTM in Europe, (where the European Marketing
Authorisation Application remains on track to be filed in Q1, 2010) or
in Japan (where Phase 2 studies are expected to be completed this
year).


Net Cash

As at 31 December 2009 the Group had net cash and cash equivalents of
GBP27 million (compared with GBP22.1 million as at 30 June 2009).  The
results for the year ended 31 December 2009 are scheduled to be
announced on 25 March 2010. 



For further information please contact:


SkyePharma PLC


Ken Cunningham, Chief Executive Officer +44 207 491 1777
Peter Grant, Chief Financial Officer


Financial Dynamics

Debbie Scott/Stephanie Cuthbert         +44 207 831 3113




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 Group 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.

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

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