12th Nov 2009 07:00
SKYEPHARMA PLC - INTERIM MANAGEMENT STATEMENT
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.
Cash
As reported in the 2009 interim results, as at 30 June 2009, the Group had £23.8 million in cash and facilities and sufficient funds for the foreseeable future. Since then £5.0 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 £1.5 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
Flutiform™
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 Flutiform™. The European Marketing Authorisation Application is on track to be filed as planned in Q1 2010.
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 Flutiform™ supply chain to a third party. Discussions with one party have ceased and those with other parties are at a preliminary stage.
Solaraze®
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 £31 million compared with £15 million for Q3 2008 with most of this growth coming from Europe.
Lodotra™
In April 2009, Lodotra®, the novel night-time release formulation of low dose prednisone, utilising SkyePharma's proprietary Geoclock™ 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.
SKP-1041
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 Geoclock™ technology. Plans are being prepared for a Phase II study expected to begin in 2010.
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 way."
For further information please contact:
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SkyePharma PLC |
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Ken Cunningham, Chief Executive Officer |
+44 207 491 1777 |
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Peter Grant, Chief Financial Officer |
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Financial Dynamics |
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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 www.skyepharma.com.
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