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Sucampo-Takeda to file for US approval of Amitiza as OBD treatment

Sucampo shares up after positive phase III trial results

Sucampo Pharmaceuticals and Takeda's Amitiza (lubiprostone) has met the primary endpoint in a phase III trial in the treatment of opioid-induced bowel dysfunction (OBD).

News of the positive results prompted a surge in Sucampo's share price at the end of last week, as a joint statement from the two companies indicated they would now press ahead with filing for regulatory approval in the US in the coming months.

Amitiza is already sold in the US as a treatment for chronic constipation and irritable bowel syndrome with constipation, with sales of around $170m in the first nine months of 2011.

It is estimated that 4.5m patients in the US suffer from OBD, so extending Amitiza's indications to include this use could dramatically increase sales.

In the phase III trial, patients with chronic, non-cancer pain - excluding those taking methadone - were randomised to receive either lubiprostone or placebo twice-daily for a 12-week period. The overall spontaneous bowel movement (SBM) response rate was the primary endpoint of the study.

The response rate for lubiprostone-treated patients was 26.9 per cent compared to 18.6 per cent for the placebo group, which was a statistically significant increase.

"If approved, lubiprostone could be the first orally-administered medicine with the indication for OBD," said Sucampo's chairman and CEO Ryuji Ueno.

"If approved, lubiprostone could be the first orally-administered medicine with the indication for OBD, providing another option for patients who need it and further differentiating lubiprostone from the competition," Ueno added.

Sucampo is in the final stages of an arbitration process seeking to revise the terms of its partnership with Takeda for Amitiza.

The company has claimed that Takeda has not generated an appropriate level of sales for Amitiza, and is reportedly trying to reclaim full ownership of the product. A verdict is expected later this quarter.

6th February 2012

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