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The Food And Drug Administration Has Accepted SkyePharma PLC Partner GlaxoSmithKline’s Application For REQUIP XL 24-Hour Extended Release Tablets


SkyePharma PLC (LSE:SKP; NASDAQ: SKYE) today announces that the United States Food and Drug Administration has accepted for filing the application by its partner, GlaxoSmithKline (NYSE: GSK), for REQUIP XL 24-Hour Extended-Release Tablets, the proposed brand name for a once-daily formulation of ropinirole for treating Parkinson’s disease. It has been designed to provide a steady rate of absorption in the body to help reduce blood plasma fluctuations over 24 hours.

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 XL 24-Hour uses SkyePharma’s proprietary GeoMatrix technology and has been designed to be given once daily and to have a simpler and faster titration schedule.

On 3 April 2007, GlaxoSmithKline announced positive results of the Ropinirole 24-Hour Efficacy and Safety Evaluation in PD-Adjunct (EASE-PD Adjunct) study, which were published in the 3 April issue of Neurology. In that study, adding REQUIP XL 24-Hour once daily to Parkinson’s patients’ existing levodopa (L-dopa) therapy significantly reduced “off” time by an average of more than 2 hours per day when compared with baseline prior to treatment, thus allowing these patients to continue their daily activities for a longer period of time.

REQUIP is indicated for Parkinson’s disease and Restless Legs Syndrome in the U.S. Parkinson’s disease makes up about 40 percent of current REQUIP sales in the U.S. If approved for Parkinson’s disease, future sales of REQUIP XL 24-Hour will generate low mid-single digit royalties for SkyePharma.

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).

More than one million people in the United States have Parkinson’s disease, and it is estimated that nearly 60,000 new cases are diagnosed in the U.S. each year. Most people develop Parkinson’s disease between the ages of 40 and 70, but the disease can also develop at an earlier age.

Commenting on today’s announcement, Frank Condella, CEO of SkyePharma, said: “This is an important step towards gaining approval in the US for REQUIP XL 24-Hour which we believe has the potential to be a significant product for SkyePharma. Dopamine agonists are increasingly recommended by doctors as a first-line therapy for patients suffering from Parkinson’s disease and this new, once-daily version of REQUIP could deliver significant benefits for these patients and may improve compliance.”


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