Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited jointly announced that both parties have entered into a collaboration and license agreement for Lubiprostone (generic name) which was developed by Sucampo in the US as a novel compound with new mechanism of action for the treatment of chronic constipation and constipation-predominant Irritable Bowel Syndrome (IBS).

Under the agreement, the right to market the product in the US and Canada will be granted to Takeda, while Sucampo reserves the co-promotion right in these countries. Takeda's wholly-owned US subsidiary, Takeda Pharmaceuticals North America Inc. (TPNA) will sell this product once the product is approved by the US Food and Drug Administration (FDA). The option for marketing right in other territories including Japan and Europe will also be granted to Takeda. Takeda and Sucampo also agreed on the exclusive manufacturing and supply of Lubiprostone by R-Tech Ueno, Ltd (Tokyo, Japan), a member of Sucampo Group.

Sucampo has the potential to receive up to $210 million in initial and milestone payments, some of which are contingent upon the successful achievement of several milestones. Furthermore, as a part of the collaboration, Takeda will fund a major part of development costs not only for chronic constipation and constipation-predominant IBS but also for other indications in the gastroenterology field. Takeda will also make royalty payments to Sucampo after the product is launched. Further details are not disclosed.

Lubiprostone, an orally-administered formulation, was discovered by Ryuji Ueno, MD, PhD, PhD, chief scientific officer of Sucampo and is being developed by Sucampo for the treatment of chronic constipation and constipation-predominant IBS, based on its molecular mechanism of action as a chloride channel opener, which causes an increase in intestinal fluid secretion. In the US, the phase III studies for chronic constipation were completed and a New Drug Application (NDA) is under preparation, while for constipation-predominant IBS, the phase II studies were completed and the development stage is expected to enter phase III soon.

"This collaboration and license agreement is a major milestone for Sucampo," said president and CEO, Sachiko Kuno, PhD. "We are greatly encouraged by this strategic alliance with Takeda, which already established an excellent reputation in its ability to promote market-leading product in the US, and the synergies that will result from the combined efforts of Takeda and Sucampo, all of which will maximize market opportunity for Lubiprostone."

"We are extremely excited about entering into an agreement with Sucampo in which we will be granted the right to market Lubiprostone by Takeda", said Yasuchika Hasegawa, President and COO of Takeda. "Regarding IBS, there are at the present not so many products available and there is a definite need for new drugs that are both effective and safe. We believe that Lubiprostone will enable us to offer new treatment options for patients suffering from chronic constipation and constipation-predominant IBS".