Skyepharma

hab mir nun eine portion angeschnallt. der titel steht zwar seit längerer zeit in einem abwärtskanal. aber hoffen auf bessere zeiten darf man ja.

Gestern kam noch die nachfolgende meldung über den radar. der titel ist aber noch immer im down-kanal.

LONDON (AFX) - Skyepharma PLC said its partner Critical Therapeutics, Inc has received FDA acceptance for its New Drug Application for the twice-daily, controlled-release formulation of Zileuton.

Zileuton is a drug developed for the prevention and chronic treatment of asthma in adults and children above 12 years of age.

Critical Therapeutics expects to launch Zileuton in the second half of 2007. The anticipated PDUFA date is 31 May 2007, and the company expects the product to generate revenues in the next 12 months. newsdesk@afxnews.com tfn-mum-jro/slm

heute gehts wieder mal schön aufwärts. ist ja auch bitter notwendig. seit der top-meldung von letztem dezember lief nicht mehr gerade viel gutes.

der flotte aufwärtstrend von gestern setzt sich heute fort. es scheint als haben da plötzlich irgendwelche fondshäuser gemerkt, dass die nachricht von letztem dezember sich vermutlich positiv auf die bilanz auswirken wird.

Am montagnacht kam noch die nachfolgende news rein. dem kurs hatte es leider nicht viel genützt. aber wenigstens die beiden einzigen analysten hatten ihr rating von buy auf strong buy erhöht. Mittlerweile wird damit gerechnet, dass ab 08 ein positiver ebitda erwirtschaftet wird.

Once Daily, Extended-Release Ropinirole Improves Parkinson's Symptoms in
Patients not Optimally Controlled With Levodopa

'Off' Time Reduced By an Average of More Than Two Hours Per Day


RESEARCH TRIANGLE PARK, N.C., April 2 /PRNewswire/ -- Adding the once
daily, investigational medication REQUIP(R) (ropinirole HCl) XL 24-Hour(TM)

Extended-Release Tablets to Parkinson's patients' existing levodopa (L-dopa)

therapy significantly reduced 'off' time, allowing patients to continue their

daily activities for a longer period of time. 'Off time' describes the return

of Parkinson's symptoms as a patient's medication wears off. The Ropinirole

24-Hour Prolonged Release Randomized, Controlled Study in Advanced Parkinson

Disease (EASE-PD Adjunct Study) results, published in the April 3 issue of

Neurology, show that adjunct treatment with REQUIP XL 24-Hour significantly

reduced 'off' time by an average of more than two hours per day when compared

to baseline prior to treatment.

"'Off' time is a common phenomenon for Parkinson's patients. When
symptoms like slowness of movement, tremor and rigidity return due to wearing

off of the patient's medication, it can be problematic, causing difficulty
with simple activities and movement in patients with Parkinson's disease,"
said Rajesh Pahwa, M.D., Professor of Neurology, Director, Parkinson Disease

and Movement Disorder Center, University of Kansas Medical Center, Kansas
City, Kan., and lead investigator of the EASE-PD Adjunct study. "These study

results are significant, and show that with the investigational REQUIP XL 24-

Hour added to L-dopa, patients can have more than two additional hours per
day, on average, without experiencing the disabling symptom of 'off ' time."

REQUIP(R) (ropinirole HCl) Tablets, the immediate-release (IR)
formulation, is dosed three times daily. REQUIP XL 24-Hour has been designed

to be given once daily and to have a simpler and faster titration schedule.
In addition, it has been designed to provide a steady rate of absorption in
the body to help reduce blood plasma fluctuations over 24 hours. In the EASE-

PD Adjunct Study, REQUIP XL 24-Hour has been shown to be effective in treating

both motor and non-motor symptoms of Parkinson's disease as an addition to L-

dopa. GlaxoSmithKline sponsored this study as part of the clinical
development program for the investigational 24-hour extended-release tablet

dosage formulation of REQUIP. REQUIP XL 24-Hour is the proposed brand name
for a once-a-day formulation of ropinirole for treating Parkinson's disease

using SkyePharma Plc's (Nasdaq: SKYE; LSE: SKP) proprietary GeoMatrix

technology.

About the 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 (n=202) or placebo (n=191) in addition to L-dopa,

once daily for 24 weeks. The primary endpoint was mean change from baseline
in awake time spent 'off' (measured via patient diaries). 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.

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

publication that were statistically significant. However, there were no

significant differences between REQUIP XL 24-Hour compared to 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).

A Progressively Disabling 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).

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.

About REQUIP Tablets (Immediate-Release Formulation)

The currently marketed REQUIP Tablets, a non-ergot dopamine agonist, 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.

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.

About SkyePharma PLC

SkyePharma develops pharmaceutical products benefiting from world-leading

drug delivery technologies. 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.


Contacts:
Robin Gaitens Patricia Li
GlaxoSmithKline Cohn & Wolfe
919-483-2839 212-798-9772

SOURCE GlaxoSmithKline

/CONTACT: Robin Gaitens of GlaxoSmithKline, +1-919-483-2839; or Patricia Li
of Cohn & Wolfe, +1-212-798-9772, for GlaxoSmithKline
/Web site: https://www.gsk.com
/Web site: https://www.skyepharma.com/




(END) Dow Jones Newswires

02-04-07 2007GMT