June 16, 2008 / 11:37 AM / 10 years ago

UPDATE 1-Glaxo, SkyePharma gain on Requip XL drug approval

(Adds further analyst comment, sales forecast)

LONDON, June 16 (Reuters) - Shares in GlaxoSmithKline (GSK.L) and SkyePharma SKP.L both advanced on Monday following news Glaxo had finally won U.S. approval for its drug Requip XL as a treatment for Parkinson’s disease.

The once-daily medicine uses SkyePharma’s Geomatrix technology to give continuous delivery of the drug over 24 hours.

Shares in SkyePharma, the smaller company, had jumped 19.8 percent to 6.59 pence by 1115 GMT, while Glaxo shares were 1 percent higher at 10.85 pounds.

“We continue to contend that SkyePharma remains a fundamentally solid business that is now under management by a proactive team that should ensure profitability for the company by 2009,” says Landsbanki analyst Shawn Manning in a note.

The U.S. launch of Requip XL, which is already approved in Europe, is expected by mid-July. Its U.S. approval had been delayed because the U.S. Food and Drug Administration had further questions about the product.

    An older version of Requip that must be taken three times a day is already approved for Parkinson’s and restless leg syndrome. Requip had worldwide sales of 94 million pounds ($183.4 million) in the first quarter, with U.S. revenues accounting for 60 million of the total.

    Last month, U.S. regulators approved generic versions of that original Requip medicine for the treatment of restless leg but not Parkinson‘s.

    Dresdner Kleinwort analysts said the U.S. green light for Requip XL had been expected some time in the second quarter. They forecast sales of all formulations of Requip peaking at 360 million pounds in 2010. (Reporting by Rhys Jones and Ben Hirschler, editing by Will Waterman)

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