7 Mar 2011 07:00
SkyePharma receives notification of discontinuation of PULMICORT® pMDI production
LONDON, UK, 7 March 2011 - SkyePharma PLC (LSE: SKP) today announces that AstraZeneca has informed it of a decision to discontinue production of PULMICORT (budesonide) 100 and 200 µg/dose HFA pMDI (pressurised metered dose inhaler) due to complex manufacturing issues related to technical aspects of the device. It is not being withdrawn and supplies already manufactured or in the supply chain are continuing to be distributed until exhausted.
SkyePharma developed the formulation for PULMICORT® pMDI using its proprietary formulation technology and earns a mid-teens royalty on AstraZeneca's net sales of the product. Royalties from this product in the first half of 2010 and full year 2009 comprised about 5% of SkyePharma's revenues. This decision only impacts AstraZeneca's PULMICORT pMDI device which is a unique combination of device components.
It is expected that the decision will lead to the termination of SkyePharma's agreements with AstraZeneca for PULMICORT® pMDI. Following any termination of these agreements, certain rights for the product will revert or be licensed to SkyePharma and the Company intends to explore whether a sublicense of these rights may be of interest to other parties.
Axel Müller, Chief Executive Officer of SkyePharma, said:
"AstraZeneca's decision to cease manufacture of PULMICORT® pMDI because of problems related to the device is disappointing. However, it is one of 12 approved and marketed products which use our technology and we anticipate continued progress in our pipeline of development products this year, including FlutiformTM, which is currently being assessed by European regulators."
For further information please contact:
SkyePharma PLC |
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Axel Müller, Chief Executive Officer | +44 207 881 0524 |
Peter Grant, Chief Financial Officer |
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Singer Capital Markets Limited | |
Shaun Dobson / Claes Spång | +44 203 205 7500 |
Financial Dynamics |
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Jonathan Birt /Sue 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.