SOURCE: SkyePharma PLC

April 13, 2007 02:01 ET

SkyePharma PLC announces Once-Daily REQUIP® (ropinirole HCl) XL 24-Hour™ Extended-Release Tablets Accepted for Filing by U.S. FDA

London, UK -- (MARKET WIRE) -- April 13, 2007 --

        Once-Daily REQUIP(R) (ropinirole HCl) XL 24-Hour(TM)
     Extended-Release Tablets Accepted for Filing by U.S. FDA

LONDON, UK, APRIL 13, 2007 - 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."

 

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	

GSK European 
Analyst/Investor 
inquiries:	         Anita Kidgell	           +44 20 8047 5542
      	                 Sally Ferguson   	   +44 20 8047 5543
     	                 David Mawdsley	           +44 20 8047 5564

NOTES TO EDITORS

About the EASE-PD Study

The EASE-PD Adjunct study was a multi-center, double-blind, placebo-controlled study, conducted in patients with idiopathic Parkinson's disease not adequately controlled with L-dopa. Subjects were randomized (1:1) to receive REQUIP XL 24-Hour once daily (n=202) or placebo (n=191) in addition to L-dopa for 24 weeks. The primary endpoint was mean change from baseline in awake time spent "off" (measured via patient diaries). "Off" time describes the return of Parkinson's symptoms as a patient's medication wears off. REQUIP XL 24-Hour decreased patients' awake time spent "off" by an average of 2.1 hours per day, while placebo decreased awake time spent "off" by 0.3 hours per day compared to baseline prior to treatment.

The study also included a wide variety of motor and non-motor secondary endpoints, including "on" time which refers to the time during which medication is working and providing benefit, and "on" time without troublesome dyskinesia which refers to "on" time without involuntary movements interfering with function or causing discomfort, a common problem in Parkinson's disease. REQUIP XL 24-Hour significantly increased both "on" time and "on" time without troublesome dyskinesia by 1.6 hours per day (a greater than 12 percent increase) and reduced the percentage of "off" time by more than 12 percent compared to baseline. REQUIP XL 24-Hour also improved sleep problems associated with Parkinson's disease, as measured by the Parkinson's Disease Sleep Scale total score.

There were other motor and non-motor secondary endpoints in the study that were statistically significant. However, there were no significant differences between REQUIP XL 24-Hour and placebo in PDQ-39 subscales of social support, cognition or bodily discomfort. Additionally, there was no significant difference between REQUIP XL 24-Hour and placebo on the Epworth Sleepiness Scale total score signifying no increase in daytime sleepiness.

In the EASE-PD Adjunct study, once daily use of REQUIP XL 24-Hour was generally well tolerated. The withdrawal rate due to adverse events was low and similar between the two groups (REQUIP XL 24-Hour 5 percent versus placebo 5 percent). The most common adverse events reported in patients taking REQUIP XL 24-Hour (n=202) versus placebo (n=191) were dyskinesia (13 percent versus 3 percent), nausea (11 percent versus 4 percent), dizziness (8 percent versus 3 percent), somnolence (7 percent versus 4 percent), hallucinations (6 percent versus 1 percent), and orthostatic hypotension (5 percent versus 2 percent).

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 nine 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.

About REQUIP Tablets (Immediate-Release Formulation)

Prescription REQUIP is not for everyone. REQUIP Tablets may cause patients to fall asleep or feel very sleepy during normal activities such as driving; or to faint or feel dizzy, nauseated, or sweaty when they stand up. Patients should tell their doctor if they experience these problems or if they drink alcohol or are taking other medicines that make them drowsy. Patients should also tell their doctor if they or their family notices that they develop any unusual impulses or behaviors, such as pathological gambling or hypersexuality. Hallucinations may occur at anytime during treatment. REQUIP may potentiate the side effects of L-dopa. Side effects include nausea, dizziness, drowsiness or sleepiness, headache, and dyskinesia (uncontrolled movements). Most patients were not bothered enough to stop taking REQUIP. This is not a complete list of side effects and should not take the place of discussions with patients' healthcare providers. Their doctor or pharmacist can give patients a more complete list of side effects. Patients should talk to their doctor about any side effects they may have.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected.


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