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Drug Names(s): Requip OCR, Ropinirole OCR, Ropinirole ER, Requip LP extended-release, Requip CR (RLS)
Description: Requip extended release is an oral once-daily formulation of GlaxoSmithKline's Requip, a dopamine agonist (ie. it stimulates the dopamine receptor). The new formulation utilizes SkyePharma's Geomatrix technology.
The Requip 24-hour formulation (XL) is for Parkinson's Disease and the Requip 14-hour formulation (CR) is for Restless Leg Syndrome.
Deal Structure: Under the terms of a September 1999 agreement with GlaxoSmithKline, SkyePharma is responsible for all development activities for Requip OCR up to regulatory filing, in collaboration with GlaxoSmithKline. As part of the agreement, GlaxoSmithKline made an equity investment of 4.9 million in SkyePharma and will pay milestone payments at intervals up to product approval, including an upfront payment. In December 2001 and June 2003, SkyePharma and GlaxoSmithKline amended the 1999 license for Requip OCR to take account of additional activities that had been undertaken by SkyePharma. Under the terms of the amendments, the timeline of certain milestone payments was renegotiated together with additional development revenues to reimburse SkyePharma for the additional activities. On commercialization of Requip OCR, SkyePharma will receive royalties on future product sales. GlaxoSmithKline will take responsibility for preparing and pursuing all necessary regulatory approvals.
Until 2009, all...See full deal structure in Biomedtracker
Partners: Vectura Group
Requip XL News
Pink Sheet FDA delays action date for Requip XL
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