Chronic Idiopathic Constipation - Sucampo Submits New Drug Application for Lubiprostone, an Investigational Compound

Main Category: GastroIntestinal / Gastroenterology
Article Date: 01 Apr 2005 - 15:00 PDT

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Takeda Pharmaceutical Company Limited ("Takeda",) announced today its partner, Sucampo Pharmaceuticals, Inc., submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) on March 31, 2005 to market lubiprostone, a novel compound with a unique mechanism of action, for the treatment of chronic idiopathic constipation and associated symptoms in adults. Based on an agreement reached in October 2004, Takeda will market lubiprostone, once approved, in U.S. and Canada through their US subsidiary.

Lubiprostone, administered orally, has been shown to work locally in the GI tract by activating specific chloride channels (a protein that carries chloride) on cells lining the small intestine and increase intestinal fluid secretion. Increased fluid level softens the stool, promotes spontaneous bowel movements, and reduces abdominal discomfort, pain and bloating.

" This NDA submission marks a significant product milestone in Sucampo's history. We believe lubiprostone could provide an important new treatment option for the millions of people who suffer from chronic constipation and its symptoms," said Sachiko Kuno, Ph.D., president and chief executive officer of Sucampo. " Our studies suggest that the unique mechanism of action of lubiprostone may offer a more targeted approach to managing the symptoms of constipation."

"We are very pleased with this NDA submission by our partner Sucampo, as it surely will support the realization of our ongoing commitment to providing new and innovative options to physicians and their patients," said Yasuchika Hasegawa, president and chief operating officer, Takeda.

For the NDA application, Sucampo has provided results from two Phase 3 pivotal efficacy studies, results of a randomized withdrawal (RW) study and three long-term safety studies, including two 12-month safety studies. These pivotal studies demonstrated that lubiprostone produced rapid and sustained effects in treating the symptoms of constipation, performing significantly better than placebo in men and women over age 18 for all constipation variables tested. Further, results from the RW study indicated no rebound effect after treatment discontinuation.

In addition, a Phase 2 trial was completed that studied lubiprostone for constipation-predominant irritable bowel syndrome (IBS-C), and lubiprostone is expected to enter Phase 3 soon. Lubiprostone also is being evaluated for other bowel dysfunctions and GI disturbances.

Sucampo and Takeda reached an agreement that provided Takeda marketing rights in North America, as well as the option for marketing rights in other territories, including Japan and Europe. The manufacturing and supply of lubiprostone has been granted to R-Tech Ueno, Ltd (Tokyo, Japan), a member of Sucampo Group.

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About Constipation and Chronic Constipation

Constipation, defined as infrequent and difficult passage of stool, is one of the most common disorders suffered by Americans. It affects between 2% and 27% of the population in Western countries. In the U.S., it results in more than 2.5 million visits to physicians, 92,000 hospitalizations annually. (*1) Factors contributing to the development ofconstipation include a diet low in soluble and insoluble fiber,inadequate exercise,bowel disorders, neuromuscular disorders and poor abdominal pressure/muscular atrophy. Other contributing factors include side effects from medication, particularly narcotic analgesics, antidepressants, anticholinergics, antispasmodics and antihistamines. Chronic constipation is a disorder of colon motility which is present for at least 3 months and results in infrequent bowel movements and demonstrated difficulty in evacuating stools.

About Irritable Bowel Syndrome (IBS)

IBS is a chronic, recurrent disorder characterized by the multiple symptoms of abdominal pain and discomfort, bloating, and extreme changes of bowel habits such as constipation and/or diarrhea. IBS is considered to be one of the most common gastrointestinal disorders. It is reported that approximately 30 million people in North America meet the diagnostic criteria for IBS. (*1) There are currently few choices of treatment available for the multiple symptoms of IBS. According to the American Gastroenterological Association, the cause of IBS is not known. It is said that this disease could be caused by lifestyle or psychological stress, though the cause of the disease is not known. Patients diagnosed with IBS are commonly classified as having constipation-predominant IBS, diarrhea-predominant IBS or alternating IBS (alternating between constipation and diarrhea). The condition causes a great deal of discomfort and distress for its sufferers. While not life threatening, it can significantly interfere with daily activities and reduce their quality of life.

About Sucampo

Sucampo Pharmaceuticals, Inc. is a pharmaceutical company focusing on that concentrates on developing compounds from its proprietary functional fatty acid technology platform, which consists of exclusive rights in the Americas to a portfolio of more than 650 patents. The company, founded in 1996 by Dr. Ryuji Ueno and Dr. Sachiko Kuno in Bethesda, MD, focuses principally on developing novel therapies for gastrointestinal, liver and circulatory indications, and is strategically selecting and developing candidates for other indications. Sucampo's functional fatty acid platform is based on the discoveries of Company Founder, Dr. Ryuji Ueno. To learn more about Sucampo, visit http://www.sucampo.com.

About Takeda

Takeda Pharmaceutical Company Limited is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the industry's leaders worldwide, Takeda is committed to strive toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Takeda is actively dedicated to enhance its pipeline for future growth through alliance as well as in-house R&D activities.

(*1) New England Journal of Medicine 2003; 349: 1360-8 Lembo A, Camilleri M / "Chronic Constipation"

(*2) The American Journal of Gastroenterology 2002 ; 97(8) : 1910-1915 Saito Y, et al /"The Epidemiology of Irritable Bowel Syndrome in North America: A Systematic Review"

http://www.takeda.co.jp

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