Product Update

SKYEPHARMA PLC - UPDATE ON FLUTIFORM™ EUROPE

LONDON, UK, 23 December 2011 - SkyePharma PLC (LSE: SKP) today announces that the decentralised procedure ("DCP") for the regulatory review of Flutiform™ has been referred to the European Medicines Agency ("EMA") and its Committee for Medicinal Products for Human Use ("CHMP") for arbitration. As part of the arbitration process, all members of the CHMP are involved in the evaluation and will work together to make a decision by a majority vote on the final regulatory position of Flutiform™.

The arbitration procedure is part of the DCP and is initiated when a unanimous decision of the Reference Member State ("RMS") and Concerned Member States ("CMSs") cannot be reached in relation to granting a marketing authorisation for a medicine in Europe.

As announced on 18 October 2011, although the UK, the RMS and almost all CMSs were in agreement that the product was approvable, a complete consensus had not been achieved by Day 210 of the DCP. The procedure then moved into a referral process during which the RMS and CMSs sought a consensus on the final regulatory position. The referral process has now concluded and although the RMS and almost all CMSs continue to be in agreement that Flutiform™ is approvable, the complete consensus required for a positive outcome of the referral process has not been achieved.

SkyePharma's authorised distributor, Mundipharma International Limited ("Mundipharma"), has been informed by the UK Medicines and Healthcare products Regulatory Agency ("MHRA") that the DCP for the regulatory review of Flutiform™ has, therefore, been referred to the EMA and the CHMP for arbitration.

SkyePharma and Mundipharma are confident in the efficacy and safety profile of Flutiform™, which is supported by the clinical evidence. The Marketing Authorisation Application consisted of a substantial package of data including the results of eight phase I/II studies and nine Phase III studies conducted in a population of 4,500 patients of whichover 1,900 patients received Flutiform™.

Dr. Axel Müller, Chief Executive Officer of SkyePharma, said: "Although this regulatory delay is disappointing for SkyePharma and potential patients we remain confident in the efficacy and safety profile of Flutiform™ and will continue to work closely with our partner, Mundipharma, to seek its approval in Europe as soon as possible."

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About SkyePharma

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.