Sucampo Pharmaceuticals of Bethesda, Md.,has received a final binding decision on its claims in the dispute with its partner, Takeda Pharmaceutical: the International Court of Arbitration, International Chamber of Commerce (ICC) did not agree with Sucampo's claims and did not award any attorneys' fees or costs.
The decision confirms that the collaboration agreement and all of its terms, rights and conditions for Amitiza(lubiprostone) will remain in force until it expires in October 2020, including the royalty rate arrangement. The royalty revenue to Sucampo was $41.5 million in 2011 and $10.9 million in the first quarter of 2012. Amitiza was approved for the treatment of chronic idiopathic constipation (CIC) in adults in 2006 and for the treatment of irritable bowel syndrome with constipation (IBS-C) in adult women in 2008, and is the only FDA-approved medicine for either indication.
"Amitiza is a brand whose safety and efficacy has been proven over six years and six million patients. Through this arbitration process, we have gained a greater understanding that there is significant potential to further increase Amitiza's value, make the product available to currently underserved patients, and maximize its net sales revenue by optimizing its marketing and commercialization efforts,” said Ryuji Ueno, chairman and CEO of Sucampo. "We anticipate filing a supplemental new drug application in the near-term for the treatment of opioid-induced constipation which, if approved, would be the third indication for Amitiza."