Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that it has received a final binding decision on its claims in the dispute with its partner, Takeda Pharmaceutical Company Limited. 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. Sucampo is disappointed with the ICC’s decision.
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. AMITIZA is the only FDA-approved medicine for either of these indications.
“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.” commented Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo’s Chairman and Chief Executive Officer. “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.”
Dr. Ueno continued, “Beyond North America, we believe there are many significant opportunities for the AMITIZA franchise to grow, including through expanded indications and approvals in new territories. Yesterday, we received approval from the Japanese Health Ministry for AMITIZA in chronic constipation (excluding constipation caused by organic diseases). We anticipate that our partner, Abbott Japan Co. Ltd., will launch AMITIZA in Japan in the fourth quarter. We have also completed the Marketing Authorization Application for AMITIZA in the United Kingdom and expect approval in the second half of this year.