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

March 08, 2011 | About:
10qk

10qk

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Sucampo Pharmaceuticals Inc. (SCMP) filed Annual Report for the period ended 2010-12-31.

Sucampo Pharmaceuticals Inc. has a market cap of $169.1 million; its shares were traded at around $4.04 with and P/S ratio of 2.7.

Highlight of Business Operations:

As of March 1, 2011, there were outstanding 15,659,917 shares of the registrant s class A common stock, par value $0.01 per share, and 26,191,050 of the registrant s class B common stock, par value $0.01 per share.

In September 2010, we submitted a marketing authorization application to the Japanese Pharmaceuticals and Medical Devices Agency for lubiprostone at a dosage strength of 24 micrograms for the indication of CIC. The submission includes the results of a pivotal phase 3 efficacy trial of lubiprostone in Japanese CIC patients which met its primary endpoint with statistical significance (p<0.001) and demonstrated a safety profile consistent with previously reported clinical lubiprostone data. The primary endpoint of this trial was a change in the number of SBMs at the end of the first week of treatment. This pivotal, double-blinded, placebo-controlled trial evaluated 124 Japanese CIC patients each of whom received one lubiprostone 24-mcg, or placebo, capsule twice daily for 28 days. These top-line pivotal phase 3 efficacy results were reported in June 2010. The September 2010 submission was updated in December 2010 with the complete results of the phase 3 long-term, open-label multicenter safety trial in 209 Japanese CIC patients. Top-line results from that safety trial, which were reported by us in November 2010, demonstrated that lubiprostone was safe and well-tolerated. The data from the phase 3 safety and efficacy trials have been submitted to a scientific conference, to be held in the U.S. in May 2011, for disclosure. If AMITIZA is approved for sale in Japan, it will be the first new drug indicated for constipation in Japan in more than ten years. Currently, constipation patients in Japan are treated with laxatives, which generate annual sales of approximately $326.0 million. Magnesium oxide is a leading laxative treatment for constipation in Japan and, in 2009, generated annual sales of approximately $129.0 million. The constipation market grew by approximately 6.0% from 2008 to 2009. Future market growth is expected to continue and fueled by an increasingly older population and changes in eating and lifestyle habits.

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10qk
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