Staff Writer

Sucampo Pharma Ltd. has secured a Japanese partner for its bowel drug lubiprostone (Amitiza) in a deal that will provide the company with an up-front payment of $10 million, bolstering the company's current cash.

A unit of Bethesda, Md.-based Sucampo Pharmaceuticals Inc., the company entered into a license and commercialization agreement with Abbott Japan Co. Ltd. for Amitiza in Japan.

Under the deal, Sucampo could receive additional milestone payments, beyond the $10 million up-front payment, based on achieving specified development and commercialization goals. Sucampo plans to initiate Phase III testing of lubiprostone for chronic idiopathic constipation in Japan in the second quarter.

The company hopes to file for Japanese approval of lubiprostone in 2011.

Kate de Santis, vice president of investor relations and corporate communications at Sucampo, noted that the FDA's approval last year of Amitiza triggered a relatively large $50 million milestone payment from Takeda Pharmaceuticals, its U.S. partner for Amitiza.

But she told BioWorld Today that the company "is not expecting any big milestones this year" of that size from either of its partners.

In a conference call with investors, company management did not disclose the amount of the other potential payments that could come from partner Abbott Japan.

Sucampo also is in talks with potential partners in Europe, where it hopes to receive marketing authorization for Amitiza.

Leerink Swann analyst Gary Nachman wrote in a research note that the company's balance sheet remains strong with the $10 million up-front payment coming on top of the $121 million in cash that the company had at the end of 2008. In addition, Nachman said that sales for Amitiza appear to be growing faster than IMS sales data would suggest.

According to Sucampo, Product royalty revenue from U.S. sales of Amitiza increased by $6.9 million, or 25.1 percent, to $34.4 million for 2008 and by $1 million, or 12.4 percent, to $9.7 million for fourth-quarter 2008.

Calling 2008 a successful year, Ryuji Ueno, chairman and CEO of Sucampo, told investors that the company's "financial position is sound, sales are growing and the R&D pipeline is advancing."

He also said that the company is conserving its cash while continuing to invest in R&D.

Indeed, Sucampo had a successful year overall in 2008 but saw revenues fall off in the last three months of that year due to increased research and development expenses, according to company financial results released Thursday.

R&D expenses increased substantially for the full year 2008 and in the fourth quarter compared to the previous period in 2007. Those expenses were due primarily to the ongoing clinical development of Amitiza and two other products in development, cobiprostone and SPI-017.

A Phase II trial of cobiprostone has completed enrollment and efficacy data are expected in mid-2009. That product is being studied for the prevention of ulcers that are induced by NSAID medication for arthritis pain

Sucampo also initiated dosing in its Phase I trial of SPL-017 in Japan for the treatment of peripheral arterial disease.

In addition, the company is studying Amitiza as a potential treatment for opioid-induced bowel dysfunction (OBD) and has completed enrollment in its two pivotal Phase III trials of the drug in OBD, as well as its follow-on safety extension study.

Results are expected in the third quarter for the two pivotal studies, and additional data from the follow-on extension safety study by the end of the year.