SOURCE: SkyePharma PLC

November 12, 2009 02:00 ET

Skyepharma PLC - Interim Management Statement

LONDON--(Marketwire - November 12, 2009) -


LONDON, UK, 12 November - SkyePharma PLC (LSE: SKP) today publishes its
Interim Management Statement ("IMS") including an update on key
matters since the announcement of interim results on 21 August 2009.

Trading update

Trading continues to be in line with the Board's expectations.  As
anticipated, the second half of 2009 is benefiting from the cost
reductions which have already been implemented and the continuing
effect of price increases which were negotiated in the first
half of the year on a number of manufactured products.

Unrealised foreign exchange gains and losses on the translation of net
debt have so far had a cumulative negative impact on the Group's
results for the year, although the effect on actual cash flows is
minimised through the use of natural hedges.


As reported in the 2009 interim results, as at 30 June 2009, the Group
had GBP23.8 million in cash and facilities and sufficient funds for the
foreseeable future.  Since then GBP5.0 million net cash was received in
July from the settlement with Novartis and a sub-contractor on the
termination of the Foradil® Certihaler® contract and, in October,
a milestone of GBP1.5 million was received following the initiation
of Phase III trials by a long-standing licensing partner on an
undisclosed product. Cash usage since 30 June 2009 has been in line
with the Board's expectations.

Product and pipeline update


As previously announced, the Group's European development and marketing
partner, Mundipharma International Corporation Limited, has
successfully completed the final Phase III clinical study for the
European development of FlutiformTM.  The European Marketing
Authorisation Application is on track to be filed as planned in Q1

As previously disclosed, a meeting has been held with the Food & Drug
Administration ("FDA") in the United States and it has been confirmed
that it will be necessary to provide more data on dosing to support the
New Drug Application ("NDA").  The NDA remains under review, which the
FDA is scheduled to complete in Q1 2010, with a PDUFA (Prescription
Drug User Fee Act) goal date of 20 January 2010.  Once the FDA has
completed its review of the NDA, further discussions will be arranged
to agree the detailed protocols for the additional clinical work
needed to provide the data on dosing. It is expected, therefore,
that the additional clinical work will not begin before Q2 2010,
although preparations are already underway. As a result it is unlikely
that Flutiform will be approved and launched in the United States
before 2012.

In Japan, Kyorin is making good progress with recruitment for two Phase
II clinical studies and the development programme remains on track.

The Group continues to hold discussions with a view to transferring the
responsibility for the FlutiformTM supply chain to a third
party.  Discussions with one party have ceased and those with other
parties are at a preliminary stage.


In Q3 2009 sales of Solaraze® in all territories maintained the strong
growth seen in the first half of 2009.

Requip® Once-a-day

In Q3 2009 sales of Requip® Once-a-day were GBP31 million compared
with GBP15 million for Q3 2008 with most of this growth coming from


In April 2009, Lodotra®, the novel night-time release formulation of
low dose prednisone, utilising SkyePharma's proprietary GeoclockTM
technology and developed with Nitec Pharma AG, was launched in Germany
by Merck KGaA (Nitec's licensee for Germany and Austria). Nitec
concluded a distribution agreement with Mundipharma for the rest
of Europe and further European launches are expected during
2010.  Nitec continues to work towards registration in the United
States, and announced positive results in September from the second and
final pivotal Phase III trial (a 12-week, multicentre, double blind
trial involving 350 patients).  The NDA filing with the
FDA is targeted to take place in Q2 2010.


Somnus Therapeutics Inc has recently successfully completed two Phase I
studies of the controlled release sleep maintenance drug SKP-1041,
which also employs SkyePharma's proprietary GeoclockTM technology.
Plans are being prepared for a Phase II study expected to begin in

Dr Ken Cunningham, CEO of SkyePharma, commented, "We continue to trade
in line with the Board's expectations for the full year, with our focus
on tight control of costs helping our second half
performance.  Flutiform is on track in Japan and Europe, with
Phase III studies by our European partner, Mundipharma, successfully
meeting their primary endpoints.  We are also working to ensure that
additional dosing data requested by the FDA can be gathered in a timely

For further information please contact:

SkyePharma PLC

Ken Cunningham, Chief Executive Officer +44 207 491 1777

Peter Grant, Chief Financial Officer

Financial Dynamics

Jonathan Birt/Susan Quigley             +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

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