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Horizant gets post-shingles pain indication in US

FDA approval comes as XenoPort and partner GlaxoSmithKline remain in dispute over commercial activities to promote drug

XenoPort and partner GlaxoSmithKline have won approval to extend the indications for their restless legs syndrome (RLS) treatment Horizant to also include persistent pain after a shingles infection.

The US FDA approved Horizant (extended-release gabapentin enacarbil) for the management of post-herpetic neuralgia (PHN) in adult patients on the strength of data from three clinical trials that showed the drug controlled pain at a maintenance dose of 600mg twice-daily.

It is estimated that around 1m patients develop shingles each year in the US, with 20 per cent of them going on to develop PHN, defined as pain that persists for a month or more after the shingles lesions heal.

While the new post-herpetic neuralgia indication will expand the number of patients eligible to receive the drug, it remains to be seen whether the approval will help heal a rift between XenoPort and GSK.

Horizant started shipping in the US in June 2011 for restless legs syndrome, when it became the only non-dopamine agonist medicine licensed for the condition in the country. Prescriptions have been disappointing however, and towards the end of last year XenoPort entered into a dispute with GSK over its commercial efforts for the drug.

XenoPort had received around $195m in licensing and milestone payments when the complaint was filed - another $10m is due with the approval in PHN - and stood to receive up to $290m more on the achievement of undisclosed sales levels of Horizant.

GSK does not break down Horizant sales in its financial results, but XenoPort's first-quarter Securities & Exchange Commission (SEC) filing suggests that sales in the first quarter of 2012 were just $1.3m "as recorded by GSK".

The biotech company is seeking to terminate its agreement with GSK on the grounds of a breach of contract, while the multinational has responded with a lawsuit insisting it is meeting its commitments. The agreement remains in place for the time being, according to the SEC filing.

XenoPort has a licensing agreement with Astellas for marketing of the Horizant product under the Regnite brand in Japan and five other Asian territories, and a launch in Japan for RLS is scheduled for the third quarter of this year.

8th June 2012

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