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Sucampo Leverages Prostones Expertise, Files IPO

By Lucy Sannes, Ph.D.
Sannes & Associates
Vicki Glaser, Contributing Editor to Pharma DD, contributed to this article.

October 26, 2006

2006 has been a landmark year for Bethesda, Maryland-based Sucampo Pharmaceuticals, beginning with U.S. FDA approval of its lead drug Amitiza (lubiprostone) in January, followed by an IPO filing in June.   

This emerging company has leveraged its drug discovery and development expertise in the area of prostones to commercialize the only prescription product for the treatment of chronic idiopathic constipation (CIC) in adults and to establish a pipeline of compounds that target various gastrointestinal and liver disorders, respiratory diseases, and vascular and central nervous system disorders.  

Sucampo sealed its first major corporate partnership in October 2004, when Takeda Pharmaceutical Co. (Osaka, Japan) agreed to a 16-year collaboration and license agreement for Amitiza in the US and Canada.  

The cornerstone of Sucampo’s portfolio is a class of compounds called the prostones, which derive from functional fatty acids natural to the human body. Research on these compounds, led by Sucampo’s co-founder, CSO, and COO, Dr. Ryuji Ueno, suggests that they function as activators of cellular ion channels. As a result, the company is pursuing the therapeutic potential of prostones based on their ability to promote fluid secretion and to enhance cell protection. These mechanisms could have particular relevance for age-related diseases such as common gastrointestinal disorders, chronic obstructive pulmonary disease, non-alcoholic fatty liver disease, stroke, Alzheimer’s disease, and peripheral arterial and vascular disease.  

Sucampo’s first FDA-approved product, Amitiza, targets the adult population suffering from CIC—persistent constipation (occurring for at least 12 weeks, not necessarily consecutive, over the course of a year) with no identifiable cause. Symptoms of CIC include straining, hard stools, bloating, and abdominal pain or discomfort.  

Approximately 42 million Americans experience some type of constipation, and nearly one-third of those, or approximately 12 million people in the US , have CIC. Americans spend an estimated $350–$400 million annually on over-the-counter laxatives.¹  

In the US , constipation accounts for more than 2.5 million physician visits and 92,000 hospital visits each year. It occurs more frequently in women and in older adults.²  

In October, results presented at the annual meeting of the American College of Gastroenterology showed that 60% of patients with CIC who were given Amitiza had a spontaneous bowel movement within 24 hours of treatment, and 80% within 48 hours. Additional findings supported long-term, significant symptom relief lasting up to 12 months.  

Amitiza is a selective type-2 chloride channel activator. It increases intestinal fluid secretion, thereby softening stool and facilitating its passage through the gastrointestinal tract and alleviating constipation-related symptoms. The oral drug is approved for the treatment of CIC in adults, including those over age 65. Phase IV post-marketing studies will evaluate its effectiveness in pediatric patients with CIC and in patients with accompanying hepatic or renal failure.  

Sucampo exercised the co-promotion option under the 2004 agreement with Takeda in early 2006, and the two companies officially launched Amitiza in April.  

Amitiza competes with other available therapies for constipation that include dietary and lifestyle changes, laxatives, and Novartis’ Zelnorm (tegaserod). Zelnorm is a serotonin-4 (5-HT4) receptor selective agonist that is approved for short-term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation, and for treatment of chronic idiopathic constipation in patients less than 65 years of age.   

The success of Zelnorm illustrates the attractive market potential for Amitiza. For 2005, Novartis reported worldwide sales of $418 million for Zelnorm/Zelmac, of which $357 million represents Zelnorm sales in the US (a 43% increase over US Zelnorm sales in 2004, the year it was approved by the FDA).  

Sucampo is also studying the efficacy of Amitiza in constipation associated with IBS, which affects 10–15% of the population in North America.³ Sucampo has completed Phase II trials in IBS and has ongoing Phase II studies in opioid-induced bowel dysfunction.  

Sucampo’s second prostone in clinical development is SPI-8811, which it is developing as both an oral and an inhaled drug The oral form targets gastrointestinal and liver disorders, with a Phase II trial for the prevention and treatment of nonsteroidal anti-inflammatory drug-induced ulcers slated to begin in early 2007. In addition, Sucampo is evaluating oral SPI-8811 for the treatment of portal hypertension and non-alcoholic fatty liver disease. Sucampo has also reported plans to initiate a Phase IIb dose-ranging trial in 2007 to evaluate SPI-8811 for the treatment of gastrointestinal disorders associated with cystic fibrosis. The inhaled formulation of SPI-8811 will target respiratory symptoms associated with cystic fibrosis and chronic obstructive pulmonary disease.  

SPI-017, a prostone drug in late preclinical development, will be delivered intravenously for the treatment of peripheral artery disease in a Phase I trial scheduled for early 2007. Additionally, Sucampo’s oral formulation of SPI-017 for the treatment of Alzheimer’s disease will enter the clinic in mid- to late-2007.  
Sucampo’s pipeline of prostone drugs targets a broad range of indications and therapeutic areas with significant unmet medical need and highly desirable market opportunities. With an approved product already demonstrating the safety and potential for therapeutic benefit of this novel class of compounds, Sucampo aims to expand Amitiza’s approved indications and to explore the efficacy of related prostones and alternative delivery methods.
 

1. Study Shows Zelnorm Effective and Well Tolerated for Treating Chronic Constipation. Market Wire, May 2003; http://findarticles.com/p/articles/mi_pwwi/is_200305/ai_mark02053902.
2. Lembo A and Camilleri M. Chronic constipation. N Engl J Med. 2003;349(14):1360–1368.
3. Saito YA,  Schoenfeld P, Locke GR 3^rd. The epidemiology of irritable bowel syndrome in North America : a systematic review. Am J Gastroenterol. 2002;97(8):1910–1915.

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