GlaxoSmithKline: reformulation of Parkinson's drug set for success

13th April 2007
By Charlotte Mackey
http://www.pharmaceutical-business-r...5-CEA8387044C3

A once-daily formulation of GlaxoSmithKline's Parkinson's disease drug Requip (ropinirole) has been filed for approval with the FDA. The improved dosing regimen of Requip XR will be successful in reducing pill burden and although generic ropinirole will be a major barrier to entry, GSK's sales and marketing experience will ensure the reformulation captures substantial market share.
Parkinson's disease (PD) is a progressive, degenerative condition of the central nervous system characterized by tremor at rest, rigidity and bradykinesia (slowness of movement). PD is one of the most common neurodegenerative diseases and is estimated to affect 1.4 million individuals across the seven major markets. There remains considerable need for more effective PD therapies, particularly to treat the early and late stages of the disease.

GlaxoSmithKline's extended-release formulation of Requip, a dopamine agonist for the treatment of PD, will be marketed as a once-daily pill offering greater patient convenience. It is expected that as with the immediate release formulation, Requip XR will be approved for all stages of PD. Requip XR for the treatment of restless legs syndrome was also filed with the FDA in October 2006.

The launch of Requip XR will have a substantial impact on the market, despite the availability of generic ropinirole towards the end of 2007 which represents a major barrier to entry. Parkinson's disease sales of Requip XR are forecast to reach $373 million in 2011 following launch in Q1 2007.

A key advantage of Requip XR is the improved convenience conferred by once-daily dosing over current dopamine agonist treatments, which are generally of a three times daily dosing. Moreover, the convenient dosing of Requip XR is likely to be viewed more favorably than Schwarz's recently launched Neupro patch: while the once-daily patch is a convenient method of delivery over multiple daily doses, a once-daily tablet is simpler still. In addition, Requip XR is expected to provide smoother plasma levels of ropinirole which may lead to a reduction in side effects associated with high drug levels caused by pulsed administration.

Ultimately, however, the commercial success of Requip XR will be driven by prescriber loyalty to the Requip brand and GSK's impressive sales and marketing strength. Uptake will benefit from the pharma giant's significant neurology sales force and its considerable experience in successfully switching patients from IR to XR formulations of its brands, as exemplified by GSK's other successful CNS brand, Paxil.

SkyePharma Submits New Version of Requip for Approval

Posted on: Friday, 13 April 2007, 12:00 CDT
http://www.redorbit.com/news/health/...ource=r_health

The FDA has accepted SkyePharma's application for a new extended release version of Requip for the treatment of Parkinson's disease.

SkyePharma said Requip extended release has been designed to provide a steady rate of absorption in the body to help reduce blood plasma fluctuations over 24 hours. The drug uses SkyePharma's GeoMatrix technology and has been designed to be given once daily and to have a simpler and faster titration schedule. The drug is manufactured by GlaxoSmithKline.

GlaxoSmithKline previously reported positive results from a safety and efficacy evaluation of Requip. In that study, Requip XL 24-hour once daily was added to Parkinson's patients' existing levodopa therapy which significantly reduced "off" time by an average of more than 2 hours per day when compared with baseline prior to treatment.

If approved for Parkinson's disease, future sales of Requip will generate low mid-single digit royalties for SkyePharma.

Commenting on the announcement, Frank Condella, CEO of SkyePharma, said: "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."

Source: Datamonitor