17th Jul 2009 07:00
SKYEPHARMA PLC - Settlement of Formoterol Certihaler™ Termination
LONDON, UK, 17 July 2009 - SkyePharma PLC (LSE: SKP) today announces that it has reached agreement with Novartis Pharma AG ("Novartis") and with a subcontractor on immediate termination of the contracts relating to formoterol Certihaler™. The agreements follow the decision not to proceed with US commercialisation of formoterol Certihaler™ as announced in December 2008.
The net effect of the termination agreements will result in an exceptional gain to SkyePharma in the 2009 accounts of approximately £5 million leading to a net cash benefit in the second half of 2009 of a similar amount. The cessation of production resulted in a £5.9 million exceptional charge in the Group's 2008 accounts mainly relating to asset write-downs. Following the termination, SkyePharma retains exclusive rights for the SkyeHaler™ device, used in the formoterol Certihaler™, which was approved in the United States in December 2006 for use as a multi-dose dry powder inhaler.
As previously announced, discussions on commercialising formoterol Certihaler™ with a third party ceased following recommendations by the Joint Advisory Committees of the US Food and Drug Administration ("FDA") that the benefits of long-acting beta2-agonists administered alone did not outweigh the risks in current asthma indications.
SkyePharma is seeking other potential applications for its proprietary SkyeHaler™ dry powder inhaler. SkyeHaler™ is a multi-dose reservoir device suitable for acute and chronic therapies with a dose counter and an end of life lock out mechanism.
Dr Ken Cunningham, Chief Executive, said: "It was disappointing that formoterol Certihaler™ could not be commercialised, but we are pleased to have reached a settlement which includes a substantial cash receipt as well as enabling us to seek alternative uses for the SkyeHaler™ device, which remains one of very few dry powder inhaler devices which have been incorporated in an approved product in the United States."
Interim results
Please note that the Group will release its interim results for the six months ending 30 June 2009 on Friday 21 August 2009 and not Thursday 27 August 2009 as previously announced.
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 |
+44 207 831 3113 |
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Susan Quigley |
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.
Certihaler™ is a trademark of Novartis.
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