Skyepharma PLC - Interim Management Statement
Trading
Overall trading continues to be in line with the Board’s expectations, with no significant changes in the financial position or outlook for 2011 since the preliminary announcement. As previously reported, a milestone of £1.5 million has been received from GlaxoSmithKline on commencement of Phase III trials of an inhalation product incorporating some of the Group’s technology and this has offset the effect of a slower than anticipated start of some contract development and manufacturing projects.
Pipeline and product updates
The review of the European Marketing Authorisation Application (“MAA”) for Flutiform™ is progressing and preparations are continuing for its potential launch in H2 2011.
Good progress continues to be made with two Phase III clinical trials of Flutiform™ in Japan. The target remains to file the New Drug Application (“NDA”) during the fiscal year ending March 2013 and, subject to receiving approval, launch during the fiscal year ending March 2015.
In the United States, the Board’s strategy continues to be to seek a potential partner to finance any substantive additional work required whilst seeking clarity on the requirements for the approval of Flutiform™. In April 2011, the U.S. Food and Drug Administration (“FDA”) announced that it will require manufacturers of existing marketed products containing long-acting beta agonists (LABA) to conduct substantial, long-term, post-approval clinical studies to further evaluate the safety of these products. The FDA’s announcement did not provide guidance on how these requirements might apply to products not yet on the market, such as Flutiform™. The FDA has previously advised that, if Flutiform™ is approved, there would be a requirement for a post-marketing, long-term safety study. Clarification will be sought on any post-marketing commitment as part of continuing discussions with the FDA to confirm the scope of work required for approval of Flutiform™ in the United States.
As previously announced, generic versions of the lower-dose formulations of Sular® were approved and launched in the U.S. in January 2011 and this is adversely impacting sales of Sular®. In March 2011, a fire at a packaging sub-contractor destroyed several batches of Sular® and Triglide® supplied to Shionogi Pharma, Inc. (“Shionogi”) and packaging operations were severely disrupted. Shionogi is taking steps to refill the supply chain and has informed the Group that it intends to maintain both products on the market. In view of these challenges, the Board believes that a positive outcome, whilst being sought, may be less certain for Sular® than for Triglide®.
Dr Axel Müller, Chief Executive Officer of SkyePharma, said: “We are continuing to make preparations for the European launch of Flutiform™, subject to approval, with our partner Mundipharma, and the completion of the FDA review of EXPAREL™ is expected in Q3 2011. We are also increasing our focus on business development with a view to strengthening our pipeline of projects and maximising the Group’s drug delivery capabilities and technologies.”
For further information please contact:
SkyePharma PLC
Axel Müller, 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. 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.
Mo Noonan
Senior Manager
Financial Dynamics
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