Sucampo/Takeda Collaboration and License

November 1, 2004:

"Sucampo Pharmaceuticals, Inc. (Bethesda, Maryland, 'Sucampo') and Takeda Pharmaceutical Company Limited (Osaka, Japan, 'Takeda') jointly announced today that both parties have entered into a collaboration and license agreement for Lubiprostone (generic name) which was developed by Sucampo in the U.S. 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 U.S. and Canada will be granted to Takeda, while Sucampo reserves the co-promotion right in these countries. Takeda's wholly-owned U.S. subsidiary, Takeda Pharmaceuticals North America Inc. ('TPNA') will sell this product once the product is approved by the U.S. 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."

May 16, 2005:

"SUCAMPO RECEIVES $20 MILLION FROM TAKEDA FOR DEVELOPMENT MILESTONE

BETHESDA, MD (May 16, 2005) – Sucampo Pharmaceuticals, Inc. (Sucampo), a leader in functional fatty acid research and development, today announced that it received $20 million from its business partner, Takeda Pharmaceutical Company Ltd. (Takeda), as payment for achieving a development milestone – initiation of a Phase III clinical trial of lubiprostone to treat patients with constipation-predominant irritable bowel syndrome (IBS-C).
Lubiprosotone, one of the Sucampo’s proprietary agents, is a new class of functional fatty acid that produces chloride channel-opening activity. Sucampo began clinical development of lubiprostone in 1999.

The company filed its first New Drug Application (NDA) with the U.S. Food And Drug Administration (FDA) for a chronic idiopathic constipation (CIC) indication for the agent on March 31, 2005. That submission generated the first milestone incentive payment for the company under its October 2004 partnering agreement with Takeda. Sucampo has the potential to receive up to $210 million total from Takeda if it successfully hits the milestones outlined in the agreement.

Under the agreement, Takeda and its U.S. subsidiary, Takeda Pharmaceuticals North America (Lincolnshire, Il), hold the marketing rights for lubiprostone in the U.S. for gastroenterology indications. In return, and in addition to the upfront and milestone payments, Takeda is supporting a major part of the cost to develop the agent in U.S. for treatment of CIC, IBS-C and other indications in the gastroenterology area. Sucampo, which holds co-marketing rights for the agent, will share royalty revenue with Takeda when lubiprostone sales start."