– Agreement will enhance promotion of product in gastroenterology and primary care –
Deerfield, Ill., and Lake Forest, Ill., (February 26, 2007) – Takeda Pharmaceuticals North America, Inc. (“Takeda”) and TAP Pharmaceutical Products Inc. (“TAP”) today announced an agreement with TAP to promote Sucampo Pharmaceuticals, Inc.’s (“Sucampo”) AMITIZA® (lubiprostone) approved for the treatment of chronic idiopathic constipation in adults in the United States. Developed by Sucampo, AMITIZA has been jointly promoted by Sucampo and Takeda since its approval by the U.S. Food and Drug Administration in January 2006.
The agreement was signed and became effective January 31, 2007, with TAP detailing to begin March 2, 2007. The agreement is renewable by mutual agreement upon expiry of the initial term on March 31, 2009. Takeda will pay a detailing fee to TAP. Other conditions of the agreement were not disclosed.
TAP will now promote AMITIZA to gastroenterologists and primary care physicians to whom they are currently promoting Prevacid® (lansoprazole), and will replace the contract sales force currently used by Takeda. Takeda’s sales force will continue to promote AMITIZA to gastroenterologists and primary care physicians as well.
“With this agreement, Takeda and Sucampo gain an experienced partner and will be able to leverage TAP’s premier gastroenterology and primary care sales forces to help bring AMITIZA to the significant number of adults in the U.S. suffering from chronic idiopathic constipation,” said Mark Booth, president of Takeda Pharmaceuticals North America, Inc. “This is a good strategic fit for Takeda as we continue to build our U.S. presence.”
“This partnership will leverage both companies’ strong primary and specialty care sales organizations to better serve the unique needs of our patients,” said Alan MacKenzie, president of TAP Pharmaceutical Products Inc. “It allows TAP to build upon its longstanding commitment to and expertise in serving the primary care and gastroenterology communities.”
“The combination of Takeda and TAP adds a new dimension to the U.S. distribution strategy for AMITIZA,” said Sucampo Founder and Chief Executive Officer Ryuji Ueno, M.D., Ph.D., Ph.D. “We believe this new arrangement, which now includes TAP’s sales force, will enhance the delivery of the message of AMITIZA to physicians and patients.”
About Chronic Idiopathic Constipation
Constipation is one of the most common digestive complaints, affecting more than 42 million adults in the United States. It is the cause of 2.5 million visits to physicians and 92,000 hospitalizations annually. Chronic idiopathic constipation is defined by the infrequent or difficult passage of the stool for a period of at least three months. “Idiopathic” means the cause of the constipation is unknown and not due to an underlying illness or medication. It is estimated that 12 million people in the United States can be characterized as suffering from chronic idiopathic constipation. The signs and symptoms associated with chronic idiopathic constipation include abdominal discomfort, bloating, straining and hard or lumpy stools.
About AMITIZA® (lubiprostone)
AMITIZA is indicated for the treatment of chronic idiopathic constipation in the adult population. AMITIZA should not be used in patients with a known hypersensitivity to any components of the formulation and in patients with a history of mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be evaluated prior to initiating AMITIZA treatment.
The safety of AMITIZA in pregnancy has not been evaluated in humans. In guinea pigs, lubiprostone has been shown to have the potential to cause fetal loss. AMITIZA should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with AMITIZA and should be capable of complying with effective contraceptive measures.
AMITIZA should not be administered to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment. If the diarrhea becomes severe, patients should consult their health professional.
In clinical trials, the most common adverse event was nausea (31%). Other adverse events (≥5% of patients) included diarrhea (13%), headache (13%), abdominal distention (7%), abdominal pain (7%), flatulence (6%), sinusitis (5%) and vomiting (5%).
For full prescribing information, visit www.amitiza.com .
AMITIZA® is a registered trademark of Sucampo Pharmaceuticals, Inc.
AMITIZA is the only prescription medicine approved for adults with chronic idiopathic constipation, including those over 65 years. The product was developed by Sucampo Pharmaceuticals, Inc., and has been co-promoted and co-marketed in the United States by Takeda since its approval by the U.S. Food and Drug Administration in January 2006.
Takeda Pharmaceuticals North America, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. In the United States, Takeda currently markets products for diabetes, insomnia, wakefulness and gastroenterology. Through the Takeda Global Research & Development Center, Inc. the company has a robust pipeline with compounds in development for diabetes, cardiovascular disease and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about the company and its products, visit www.tpna.com .
TAP Pharmaceutical Products, Inc.
TAP Pharmaceutical Products Inc., located in Lake Forest, Ill., is a joint venture between Abbott headquartered in Abbott Park, Ill., and Takeda Pharmaceutical Company Limited, of Osaka, Japan. TAP markets Prevacid® (lansoprazole) and Lupron Depot® (leuprolide acetate for depot suspension). For more information about TAP Pharmaceutical Products, Inc., and its products, visit the company's Web site at www.tap.com .
Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is an emerging pharmaceutical company based in Bethesda, Md. Sucampo was founded in 1996 by Sachiko Kuno, Ph.D., the company's President and Chair of the Board of Directors, and Ryuji Ueno, M.D., Ph.D., the company's Chief Executive Officer and Chief Scientific Officer. Sucampo focuses on the development and commercialization of drugs based on prostones, a class of compounds derived from functional fatty acids that occur naturally in the human body. The therapeutic potential of prostones was first identified by Dr. Ueno. In January 2006, Sucampo received marketing approval from the FDA for its first product, AMITIZA, for the treatment of chronic idiopathic constipation in adults. In October 2004, Sucampo entered into an agreement with Takeda Pharmaceutical Company Limited (Osaka, Japan) to co-promote and market AMITIZA in the United States and Canada. Sucampo's specialized sales force complements the efforts of Takeda by focusing on institutional and long-term care facilities. Sucampo has recently completed two pivotal Phase 3 clinical trials of AMITIZA for the treatment of irritable bowel syndrome with constipation (IBS-C) and expects preliminary results in Q1 2007. Phase 3 pivotal clinical trials for the treatment of opioid-induced bowel dysfunction (OBD) are expected to commence in early to mid 2007. To learn more about the company and its products, visit www.sucampo.com .
Any statements in this press release about future expectations, plans, and prospects for Sucampo, including statements containing the words "estimates," "believes," "anticipates," "plans," "expects," "will," and similar expressions, constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, many of which are outside of our control. In addition, the forward-looking statements included in this press release represent our views as of February 26, 2007. Subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to February 26, 2007.
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