SKP.L Regulatory News (SKP)

SKYEPHARMA PLC - INTERIM MANAGEMENT STATEMENT

LONDON, UK, 12 May 2010 - Ahead of its Annual General Meeting later today, SkyePharma PLC (LSE: SKP) publishes its Interim Management Statement. This provides an update on key matters since the preliminary announcement of annual results issued on 25 March 2010. 

Trading

The Group has made a good start to the year and trading continues to be in line with the Board's expectations, with no significant changes in the financial position or outlook since the preliminary announcement.

The Group is maintaining its focus on tight control of costs and expects to continue to benefit from cost reductions already achieved and from increased prices negotiated during 2009.

Pipeline and Product updates

The Group's European marketing partner, Mundipharma International Corporation Limited, filed the European Marketing Authorisation Application ("EMAA") for Flutiform™ in March 2010. The file was accepted for review this month.

The development of Flutiform™ for Japan continues in line with expectations, with preparations underway for the initiation of Phase III clinical trials.

A meeting will be held with the US Food & Drug Administration ("FDA") to discuss what steps would need to be taken before the New Drug Application ("NDA") for Flutiform™ in the United States could be approved.

On 1 April 2010, Nitec Pharma AG, the Group's licensee for Lodotra®, announced that it had merged with Horizon Therapeutics, Inc. The combined entity is known as Horizon Pharma Inc. ("Horizon"). Horizon has completed a Phase III trial for Lodotra® for the treatment of the signs and symptoms of rheumatoid arthritis. This pivotal study, conducted in the United States, met its primary end point demonstrating that patients treated with Lodotra® experienced a statistically significant improvement in ACR-20 response when compared with patients treated with placebo. Horizon anticipates it will submit an NDA for Lodotra® to the FDA in the second half of 2010. The Group will receive a low mid single digit percentage royalty on net sales in the United States and is manufacturing the product at its plant in Lyon, France. In Europe, Lodotra® was launched in Germany in 2009 and is expected to be launched in further European countries in 2010.

Notification has been received of an Abbreviated New Drug Application ("ANDA") relating to Solaraze® in the United States. Information is being collected and analysed with a view to deciding whether it would be appropriate to take action against the ANDA filer.

Following the disposal of the Injectable Business (now Pacira Pharmaceuticals Inc.) in 2007, the Group is entitled to contingent milestone payments and a 3 percent share of net sales of EXPAREL™ (formerly DepoBupivacaine™). Pacira has announced that it expects to file for regulatory approval of EXPAREL™ in the United States and Europe during 2010.

Dr Ken Cunningham, Chief Executive Officer of SkyePharma, said, "The Group has made a promising start to the year and we are particularly encouraged by the filing of Flutiform™ in Europe, where we believe it has significant potential as a new option for clinicians and patients. The Group continues to benefit from last year's restructuring and manufacturing price increases, which will help to offset costs being incurred to prepare the Flutiform™ supply chain for a potential European launch during 2011."

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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.