27th Oct 2008 07:00
SKYEPHARMA PLC - INTERIM MANAGEMENT STATEMENT
LONDON, UK, 27 October 2008 - SkyePharma PLC (LSE: SKP) today publishes its Interim Management Statement ("IMS") which is based on trading in the period 1 July 2008 to 30 September 2008, and a business update since the interim results announced on 28 August 2008.
Highlights
As announced on 23 October 2008, the clinical work required for filing of the New Drug Application for Flutiform™ in the United States has been completed successfully and the New Drug Application ("NDA") is on track for filing with the US Food & Drug Administration ("FDA") in Q1 2009.
As announced on 25 September 2008, SkyePharma finalised the new terms of the 2024 and 2025 convertible bonds, deferring the earliest dates at which the bondholders may call for repayment (initial put dates) to November 2013 and December 2014 respectively, and completed the placing and open offer, raising £18.4 million (net of expenses of the fund raising).
As in the first half of the year, revenues since 1 July 2008 continue to show significant growth compared with the 2007 run rate, primarily driven by increases in contract research and development, an increase in royalty income following the launches of Pulmicort® HFA-MDI, Sular® and Requip® Once-a-day, and higher manufacturing revenues, mainly from Sular®.
As anticipated, the Company's expenditure on research & development is reducing as the Flutiform™ Phase III programme for the NDA concludes.
Administration expenses have remained in line with the run rate of the first six months of the year.
The unrealised exchange gain included in net finance charges has substantially reduced from that included in the results for the six months ended 30 June 2008, primarily due to the strengthening of the US dollar against sterling.
Dr Ken Cunningham, CEO of SkyePharma, said: "This has been a period of significant progress for SkyePharma during which we have completed a successful fund raising and restructured our finances. Last week we announced excellent top line results from the final Phase III efficacy study for Flutiform™ and we look forward to the NDA filing in the United States in Q1 2009. With growing revenues from across our portfolio and declining costs for the development of Flutiform™, we continue to focus on moving SkyePharma towards long term profitable growth."
Products and pipeline updates
Flutiform™
Excellent progress continues to be made with the development of Flutiform™. As previously reported, primary endpoints have been 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. The NDA is on track to be filed in the United States in Q1 2009.
The development programme for Flutiform™ also continues to make good progress in Europe, with positive results previously reported from three Phase III studies involving 589 patients. The additional higher dose strength efficacy study is now underway. The target date for filing the Marketing Authorisation Application for Europe remains the third quarter of 2009.
Discussions are continuing on seeking to transfer the management and some of the risks and responsibilities of the supply chain for Flutiform™.
Foradil® Certihaler™
Negotiations are in progress with a potential marketing and distribution partner with a view to launching the approved Foradil® Certihaler™ in the United States in 2009.
Lodotra™
Nitec Pharma AG ("Nitec") now expects European approvals within a few months, with the launch in Germany by Merck KGaA taking place shortly thereafter. Nitec is working on a program for US registration and the filing with the FDA is anticipated to take place in 2010.
Paxil CR™
Following the launch by Mylan Pharmaceuticals Inc of a generic version of Paxil CR™ in May 2008, generic erosion has been, as expected, quite rapid. By the end of August 2008, approximately 80% of new prescriptions and approximately 75% of total prescriptions were being written for the generic form of the product.
Pulmicort® HFA-MDI
Pulmicort® HFA-MDI, containing AstraZeneca's inhaled corticosteroid Pulmicort® (budesonide), has recently gained approval in the UK and has now been approved and launched in a large number of the markets in which the CFC MDI formulation of Pulmicort® had previously been sold.
Requip® Once-a-day
Requip® Once-a-day continues to be rolled out as an enhanced replacement for the immediate release, three times a day formulation for the treatment of Parkinson's disease. Requip® Once-a-day has now been launched in the United States (as Requip® XL) and most European countries.
Sales in Q3 2008 were £15m.
Solaraze®
Solaraze® is showing good growth in all key territories. Following launch in Australia in the third quarter of 2007, Solaraze® has already achieved market share of nearly 50%. A new 50g tube has recently been launched in the UK and Germany.
Sular®
The new formulation of Sular® which was launched in March 2008 by Sciele Pharma, Inc., a Shionogi company ("Sciele"), has achieved a significant level of conversion from the old formulation of Sular®. Generic formulations of the 40mg, 30mg and 20mg dosages of the old formulation of Sular® were approved in July 2008; however, a generic formulation of the 10mg dose of the old Sular® has not been approved. Shionogi & Co., Ltd completed its acquisition of Sciele on 9 October 2008.
Triglide
Triglide (fenofibrate), an oral treatment for elevated blood lipid disorders, continues to be sold in the United States by Sciele, alongside Fenoglide™, a fenofibrate product in-licensed from LifeCycle Pharma A/S ("LifeCycle"). 2008 first half sales showed substantial growth compared with the same period in 2007, although based on recent IMS data there has been some decline in new prescriptions.
Xatral® OD
There have been no developments for Xatral® OD since the interim results announcement on 28 August 2008.
ZYFLO CR® (zileuton) Extended-Release Tablets
Critical Therapeutics launched ZYFLO CR® in the United States together with its co-promotion partner, Dey, L.P., at the end of September 2007. Critical Therapeutics is continuing to work on a potential solution to the previously announced product release specification issues on a number of batches. Based on the current level of sales of ZYFLO CR® and the release of additional supplies in August and September 2008, Critical Therapeutics estimates that wholesale distributors and retail pharmacies will have a sufficient inventory of ZYFLO CR® to continue to provide product to patients throughout the fourth quarter of 2008. The previously announced merger between Critical Therapeutics and Cornerstone BioPharma Holdings, Inc is targeted to close in the fourth quarter of 2008. SkyePharma has had positive discussions with Cornerstone about the continuing business relationship once the merger with Critical Therapeutics closes.
SKP-2045
Work on the previously announced collaborative feasibility project with Dr. Reddy's has been stopped pending further assessment.
SKP-1041
Progress continues to be made with the development of the sleep maintenance product, SKP-1041, licensed to Somnus, in line with the Board's expectations. This product is a new, controlled release, formulation of zaleplon, a non-benzodiazepine hypnotic agent, utilising SkyePharma's proprietary GeoClock™ technology. It is designed to treat insomniacs who have difficulty maintaining sleep but do not have difficulty with sleep onset.
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, Finance Director |
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Financial Dynamics (London enquiries) |
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David Yates / Jonathan Birt |
+44 207 831 3113 |
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Trout Group (US enquiries) |
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Seth Lewis / Brandon Lewis |
+1 617 583 1308 |
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 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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