SOURCE: SkyePharma PLC

April 23, 2007 03:00 ET

Skyepharma PLC announces Regulatory Approval

London, UK -- (MARKET WIRE) -- April 23, 2007 --

   Once-Daily REQUIP(TM) LP Extended-Release Tablets Approved in France

LONDON, UK, Monday, April 23, 2007 - SkyePharma PLC (LSE:SKP; NASDAQ: SKYE) today announces that regulatory approval has been received in France for ropinirole prolonged release tablets (which will be marketed as REQUIP™ LP (1) in France). The new prolonged release tablet of ropinirole is taken once daily, and is indicated for the treatment of Parkinson's disease (PD). SkyePharma's partner for the product, GlaxoSmithKline has also received approval in Slovakia, Slovenia, Latvia, Estonia and Canada, and plans to gain further marketing authorisations in other countries.

On 13 April, SkyePharma announced that the United States Food and Drug Administration had accepted for filing the application by GSK for approval to market the product in the US. REQUIP™ LP has been designed to provide a steady rate of absorption in the body to help reduce blood plasma fluctuations over 24 hours.

Frank Condella, CEO of SkyePharma, commented: "We are pleased to announce the French approval of REQUIP™ LP, a significant step in the roll-out of ropinirole prolonged release tablets across the Continent. In the coming months, we expect to gain additional European approvals and will continue the roll-out of this important product across other member states of the European Union."

For further information please contact:

SkyePharma PLC                     Frank Condella         +44 20 7491 1777
                                   Ken Cunningham
                                   Peter Grant

Financial Dynamics (UK Enquiries)  David Yates            +44 20 7831 3113
                                   Deborah Scott

Trout Group (US Enquiries)         Christine Labaree      +1 617 583 1308
                                   Seth Lewis


NOTES TO EDITORS

About Ropinirole

Ropinirole is a non-ergot dopamine agonist currently marketed as REQUIP® (ropinirole HCl) Tablets, an immediate-release formulation. It has an indication in the U.S. for the treatment of the signs and symptoms of idiopathic Parkinson's disease and is administered three times a day. REQUIP™ LP uses SkyePharma's proprietary Geomatrix™ technology and has been designed to be given once daily and to have a simpler and faster titration schedule.

Our partner GSK conducted two pivotal studies to support of the registration of ropinirole prolonged release tablets in Europe. One study was a ropinirole monotherapy study in early PD, and the other was an adjunct study with levodopa (L-dopa) in advanced PD. These studies confirmed the efficacy of ropinirole prolonged release tablets, in terms of symptomatic control to allow patients to continue their daily activities.

About Parkinson's Disease

Parkinson's disease is a chronic, progressive and debilitating neurological condition that impairs the body's ability to move and balance. Researchers have determined that Parkinson's disease involves pathways in the brain responsible for motor control that are functioning improperly. Patients with Parkinson's disease experience a reduction in dopamine, a key chemical in the brain that communicates messages about movement, resulting in the symptoms of Parkinson's disease. These symptoms may include bradykinesia (slower-than-normal voluntary movements), rigidity (stiffness), tremor (involuntary shaking) and postural instability (trouble with balance).

In Europe, an estimated 800,000 people live with PD, with about 75,000 new cases diagnosed every year.(i) The correct medication is key to helping them maintain a good quality of life and minimising long-term side effects. As with many diseases, compliance is a significant barrier to positive patient outcomes in PD.

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 Company has ten approved products in the areas of oral, inhalation and topical delivery that are marketed throughout the world by leading pharmaceutical companies.

For more information, visit www.skyepharma.com

About GlaxoSmithKline

GlaxoSmithKline, with U.S. operations in Philadelphia and Research Triangle Park, N.C., is one of the world's leading research-based pharmaceutical and health care companies.

1. In the other member states of the European Union, the product suffixes under consideration are REQUIP-MODUTAB™, REQUIP™ XL, or REQUIP DEPOT™. REQUIP, MODUTAB AND DEPOT are trademarks of the GlaxoSmithKline group of companies.

i European Federation of Pharmaceutical Industries and Associations: Disease Burden in Europe. http://www.efpia.org/Content/Default.asp?PageID=133 (Accessed April 2007).


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