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GlaxoSmithKline (GSK) and SkyePharma Inc. (SKYE) Gain on Requip XL Drug Approval


6/16/2008 6:18:22 AM

LONDON, UK, 16 June 2008 -- SkyePharma PLC (LSE:SKP.L - News) today announces that the United States Food and Drug Administration (FDA) has approved GlaxoSmithKline's (NYSE:GSK - News) Requip® XL(TM) (ropinirole extended-release tablets). Requip® XL(TM) is the first and only once-daily oral non-ergot dopamine agonist indicated for Parkinson's disease. The product is expected to be available in U.S. pharmacies in mid-July 2008.

The new Requip® XL(TM) formulation uses SkyePharma's patented Geomatrix(TM) technology. This innovative tri-layer formulation allows for continuous delivery of ropinirole over 24 hours to provide smooth blood levels. Extended-release ropinirole offers physicians and patients a simple titration regimen; it also offers a convenient, once- daily dosing schedule compared to other oral dopamine agonists, which are dosed multiple times a day.

Requip® XL(TM) is currently approved in 23 countries in Europe for the treatment of Parkinson's disease. SkyePharma will receive low-mid single digit royalties on sales.

The pivotal study showed that adding Requip® XL(TM) to patients' existing levodopa ("L-dopa") therapy reduced the amount of "off" time experienced by patients with Parkinson's disease by more than two hours per day on average, compared with baseline. "Off" time is experienced by patients with Parkinson's disease when their medication wears off and their symptoms return. "Many patients require multiple doses of one or more medications to control their Parkinson's symptoms, which makes taking their medicines correctly and at the right times challenging. In addition, patients with Parkinson's disease may have trouble completing routine activities of daily living and self-care," said clinical investigator Rajesh Pahwa, M.D., professor of Neurology and director of the Parkinson's Disease and Movement Disorder Centre at the University of Kansas Medical Centre in Kansas City. "Requip® XL(TM) provides continuous delivery of ropinirole over 24 hours to provide smoother blood levels without the peaks and troughs that multiple daily doses typically deliver. It is an important once-daily treatment option for patients with Parkinson's disease."

Frank Condella, Chief Executive Officer of SkyePharma added: "We are delighted by today's FDA approval of Requip® XL(TM) which uses our unique Geomatrix(TM) technology. This represents yet another successful collaboration between SkyePharma and GSK and demonstrates the clinical value of our drug delivery technologies."

FDA approval was based primarily on results from the EASE-PD (Efficacy And Safety Evaluation in Parkinson Disease) Adjunct Study, a multi-centre, double-blind, placebo-controlled study conducted in patients with idiopathic Parkinson's disease not adequately controlled with L-dopa. A total of 393 patients in the study were randomized to receive either extended-release ropinirole (n=202) or placebo (n=191) once daily for 24 weeks, in addition to L-dopa. The study's primary endpoint was the mean change from baseline at week 24 in awake time spent "off", which was measured via patient diaries. Results from the study showed that extended-release ropinirole significantly reduced "off" time by an average of 2.1 hours per day from baseline, compared with a reduction of 0.4 hours per day for placebo.

Once-daily use of extended-release ropinirole was generally well tolerated in the study. The withdrawal rate due to adverse reactions was low and similar between groups (6 percent extended-release ropinirole vs. 5 percent placebo). The most common adverse reactions reported in patients taking extended-release ropinirole compared with placebo were dyskinesia (13 percent vs. 3 percent), nausea (11 percent vs. 4 percent), dizziness (8 percent vs. 3 percent), hallucination (7 percent vs. 3 percent), somnolence (7 percent vs. 4 percent), abdominal pain/discomfort (6 percent vs. 3 percent) and orthostatic hypotension (5 percent vs. 1 percent).

For further information please contact:

SkyePharma PLC Frank Condella +44 20 7491 1777 During office hours Ken Cunningham Peter Grant Financial Dynamics (UK Enquiries) David Yates +44 20 7831 3113 Outside office hours Deborah Scott Trout Group (US Enquiries) Christine Labaree +1 617 583 1308 Seth Lewis

About SkyePharma PLC

Using its proprietary drug delivery technologies, SkyePharma develops new formulations of existing products to provide a clinical advantage and life-cycle extension. The Company 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 http://www.skyepharma.com.

About GlaxoSmithKline

Requip® XL(TM) was developed and is marketed by GlaxoSmithKline, one of the world's leading research-based pharmaceutical and healthcare companies. For more information regarding Requip® XL(TM), please see the Complete Prescribing Information available at http://www.gsk.com. More information on GlaxoSmithKline is available at the company's website at http://www.gsk.com.

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