Pharmaceutical firms sign licence agreement for Rescula eye drops

Rescula eye drops are to be licensed across the world by Sucampo Pharmaceuticals Incorporated's wholly-owned subsidiary Sucampo Manufacturing & Research AG and R-Tech Ueno Ltd.

These eye drops contain the active pharmaceutical ingredient unoprostone isopropyl.

They are designed to lower intraocular pressure (IOP) in patients with primary open-angle glaucoma and ocular hypertension who have proven to be intolerant of or unresponsive to other medicines that lower IOP.

Sucampo currently had the rights to license the eye drops in the US and Canada, but the new agreement means this will expand across the rest of the world, except for in Japan, Korea, Taiwan and China.

"We are very excited about this agreement, as we believe that unoprostone isopropyl has significant potential in several markets," said Dr Ryuji Ueno, chairman and chief executive officer at Sucampo Pharmaceuticals.

According to the NHS, about 480,000 people have chronic open-angle glaucoma in England and other forms of the condition are less common.

Sucampo Pharmaceuticals acquires SAG

Sucampo Pharmaceuticals, Inc., or SPI, a biopharmaceutical company, has announced the acquisition of Sucampo AG, or SAG, a patent-holding company and its wholly-owned subsidiary, Sucampo AG Japan, or SAGJ. The acquisition enables SPI to secure control and ownership of the patents and other intellectual property underlying SPI's current and future prostone products including Amitiza, cobiprostone, SPI-017, and other compounds. It also eliminates future royalty and milestone payment obligations to third-party companies outside of SPI and its wholly-owned subsidiaries, and removes certain mandatory funding requirements for the development of early-stage compounds that would otherwise be needed to maintain rights to the promising drug candidates generated by the prostone technology platform. The total purchase price is $80.0 million, consisting of a cash payment of $28.1 million at closing, and a 7-year subordinated unsecured promissory note of $51.9 million. In addition, the purchase price will be increased by an amount equal to 15%, up to a maximum of $40.0 million, of any cash that may be received by SPI in connection with the current arbitration proceedings initiated by SPI against Takeda Pharmaceutical Company Limited. Besides SAG's intellectual property rights, SPI acquires about $26.2 million in net assets at SAG consisting mainly of cash. Net cash out-flow upon signing of the acquisition was therefore $1.9 million and as a result, management does not expect any significant financial impact on SPI's operations or future initiatives. Manatt, Phelps & Phillips, LLP served as special counsel to the Audit Committee and Houlihan Lokey served as financial advisor to the Audit Committee. Anthony Celeste, SPI's lead independent director, said, "In addition to the control and ownership of the intellectual property underlying the company's products and pipeline candidates, the acquisition advances SPI toward its goal of becoming a global, fully integrated biopharmaceutical company, simplifies our company's organization and certain of its operations, and further aligns the interests our company with those of its co-founders and majority shareholders."

Sucampo, Takeda bowel-drug study shows mixed data

* Drug fails in one trial, succeeds in another

* To continue another follow-on trial

* Sucampo shares up 8 pct

Sucampo Pharmaceuticals Inc (SCMP.O) and a unit of Japan's Takeda Pharmaceutical (4502.T) said two identical late-stage trials of their experimental drug for opioid-induced bowel dysfunction (OBD) showed mixed results, with one study meeting the main goal and the other failing.

The study named OBD0631 met the main goal of showing a statistically significant change in the frequency of spontaneous bowel movements at the eighth week of treatment when the drug, lubiprostone, was compared to a dummy drug.

However, another trial, named OBD0632, failed to achieve the same goal.

Sucampo will continue another follow-on safety study in 445 patients who would receive one 24-mcg gel capsule of lubiprostone twice a day for nine months. It expects data from this study in late 2009.

If the follow-on study is successful, Sucampo expects to submit the data to U.S. health regulators in 2010.

Sucampo shares were up 8 percent at $7.00 in trading after the bell. They closed at $6.50 Tuesday on Nasdaq.

Sucampo Board of Directors Issues Statement Regarding Sales Performance by Takeda Pharmaceuticals North America for AMITIZA

BETHESDA, Md.-Sucampo Pharmaceuticals, Inc., (NASDAQ:SCMP), an international biopharmaceutical company, today announced that, at its Board of Directors meeting, the Board received a report from management regarding AMITIZA® sales. In response, the Board of Directors expressed its disappointment with the level of U.S. AMITIZA sales being generated by Takeda Pharmaceuticals North America, a wholly owned subsidiary of Takeda Pharmaceutical Co. Ltd. Sucampo is looking into ways to address the situation and is engaged in ongoing discussions with Takeda to explore ways to improve AMITIZA sales. In addition, Sucampo intends to exercise its rights to pursue a performance audit under its contract with Takeda.

Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman and Chief Executive Officer, said, “We remain hopeful that we can find a solution to this situation that results in a positive outcome for both companies.”

Sucampo Pharmaceuticals Inc. Reports Operating Results (10-Q)

Sucampo Pharmaceuticals Inc. (SCMP) filed Quarterly Report for the period ended 2009-03-31.

Sucampo Pharmaceuticals Inc. is an emerging pharmaceutical company focused on the discovery development and commercialization of proprietary drugs based on prostones a class of compounds derived from functional fatty acids that occur naturally in the human body. Sucampo is focused on developing prostones for the treatment of gastrointestinal respiratory vascular and central nervous system diseases and disorders. Sucampo Pharmaceuticals Inc. has a market cap of $284.1 million; its shares were traded at around $6.79 with a P/E ratio of 12.6 and P/S ratio of 2.5.

Highlight of Business Operations:

Research and development revenue was $5.5 million for the three months ended March 31, 2009 compared to $6.1 million for the three months ended March 31, 2008, a decrease of $584,000 or 9.6%. This decrease was primarily due to reduced revenue recognized in respect to the pediatric, renal, hepatic and OBD trials for Amitiza funded by Takeda, offset in part by $374,000 in revenue recognized from the initial $10.0 million upfront payment received under the agreement with Abbott in Japan. The revenue from the upfront and development milestone payments from Abbott in Japan are being recognized using a percentage of completion model through the estimated date of approval of CIC by the regulatory authorities of Japan.

Total research and development expenses for the three months ended March 31, 2009 were $10.0 million compared to $11.2 million for the three months ended March 31, 2008, a decrease of $1.2 million or 11.2%. During the three months ended March 31, 2008, we incurred filing and data purchase costs of approximately $2.5 million, which were necessary to submit our European regulatory filings. No such expenditure was recorded during the three months ended March 31, 2009. The increase in the SPI-017 costs reflect the costs associated with the ongoing phase 1 trial for SPI-017 for peripheral arterial disease in Japan as well as non-clinical expenses for the exploration of other indications.

Milestone royalties — related parties expense was $500,000 for the three months ended March 31, 2009, reflecting the 5% royalty payment we owed to SAG as a result of the $10.0 million upfront payment we received from Abbott. We expensed $1.0 million for the three months ended March 31, 2008, reflecting a payment to SAG in connection with our European regulatory filings. We are required to pay $1.0 million for the first foreign regulatory filing, in each of the three following territories covered by the license agreement with SAG: North, Central and South America (including the Caribbean); Asia; and the rest of the world. Our European filings represented the first such filing for the rest-of-the-world territory.

We recorded a tax provision of $401,000 and a tax benefit of $5.6 million for the three months ended March 31, 2009 and 2008, respectively. The tax provision for the three months ended March 31, 2009 mainly pertained to taxable income generated by our U.S. subsidiary. Our other subsidiaries based in Japan and Europe incurred pre-tax losses for the three months ended March 31, 2009, for which no tax benefit was recognized. The tax benefit recorded for the three months ended March 31, 2008 was primarily due to a reversal of U.S. deferred tax asset valuation allowances of $4.8 million based on a $50.0 million milestone payment from Takeda and expected increase of product royalty income. As of March 31, 2009, we had an outstanding non-current income tax liability of $525,240 for uncertain tax positions which represented the aggregate tax effect of differences between tax return positions and the amounts otherwise recognized in the our condensed consolidated financial statements. The liability for uncertain tax positions as of March 31, 2009 was mainly a result of our interpretation of nexus in certain states related to revenue sourcing for state income tax purposes.

Net cash provided by operating activities was $7.3 million for the three months ended March 31, 2009. This reflected a net loss of $1.8 million, which included a non-cash unrealized loss on settlement rights of $2.4 million, offset in part by a $2.7 million unrealized gain on trading securities, an increase in deferred revenue of $7.2 million, and an increase in accounts payable of $1.4 million and a $1.4 million increase in prepaid and income taxes receivable and payable, net. The increase in deferred revenue primarily related to a $10.0 million upfront payment from Abbott upon execution of the license and commercialization agreement by Sucampo Japan in February 2009.

Net cash used in operating activities was $380,000 for the three months ended March 31, 2008. The net income of $505,000 was offset primarily by a non-cash reversal of deferred tax asset valuation allowances of $5.6 million, an increase in product royalties receivable of $2.6 million related to product royalty revenue for Amitiza, an increase in prepaid and income taxes receivable and payable of $1.8 million, an increase in accounts payable of $1.4 million and a decrease in accrued liabilities of $1.6 million.