Sucampo And Takeda Announce Filing Of Supplemental New Drug Application For AMITIZA (Lubiprostone) In Opioid-induced Constipation

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) (SPI) and Takeda Pharmaceuticals U.S.A. Inc. (TPUSA) today announced the filing of a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) seeking approval for a new indication for AMITIZA® (lubiprostone) for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.

The filing is based on results from three Phase 3, well-controlled studies of 12 weeks’ duration in patients taking opioids chronically for non-cancer pain, as well as a long-term, open-label safety study, which provide additional support for use in this population.

“We believe that the data provided in the sNDA application demonstrate that lubiprostone could provide a potential oral treatment option for patients with OIC,” said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman and CEO of SPI. “We are seeking priority review of this application, as we believe physicians and their patients are in need of new therapies to address OIC that may not affect opioid analgesia. If approved, this would be the third indication for the lubiprostone franchise and allow more patients access to this medicine.”

Opioid-induced constipation is one of the most common side effects of opioid-based medicines, which are used in the management of chronic pain. OIC affects the majority of patients treated chronically with opioids. Some patients discontinue opioid therapy and thereby endure pain rather than suffer from the constipation the opioids cause.

“This submission is an important milestone for both companies,” said Charlie Baum, Vice President, U.S. Medical Affairs, Takeda. “It is critical that we continue to identify and respond to unmet needs of patients with constipation, including OIC.”

About Lubiprostone

AMITIZA (lubiprostone) is a chloride channel activator indicated for the treatment of chronic idiopathic constipation (24 mcg twice daily) in adults and for irritable bowel syndrome with constipation (8 mcg twice daily) in women 18 years of age and older by the FDA in the United States. AMITIZA (lubiprostone) is approved in Japan for the treatment of chronic constipation (excluding constipation caused by organic diseases) and in Switzerland for chronic idiopathic constipation.

Important Safety Information

Lubiprostone is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating healthcare provider to confirm the absence of such an obstruction prior to initiating lubiprostone treatment.

The safety of lubiprostone in pregnancy has not been evaluated in humans. Lubiprostone 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 lubiprostone and should be capable of complying with effective contraceptive measures.

Patients taking lubiprostone may experience nausea. If this occurs, concomitant administration of food with lubiprostone may reduce symptoms of nausea. Patients who experience severe nausea should inform their healthcare provider.

Lubiprostone should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment and inform their healthcare provider if the diarrhea becomes severe.

Patients taking lubiprostone may experience dyspnea within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Patients who experience dyspnea should inform their healthcare provider. Some patients have discontinued therapy because of dyspnea.

In clinical trials of lubiprostone (24 mcg twice daily vs. placebo; N=1113 vs. N=316) in patients with chronic idiopathic constipation (CIC), the most common adverse reactions (incidence > 4%) were nausea (29% vs. 3%), diarrhea (12% vs. <1%), headache (11% vs. 5%), abdominal pain (8% vs. 3%), abdominal distension (6% vs. 2%), and flatulence (6% vs. 2%).

In clinical trials of lubiprostone (8 mcg twice daily vs. placebo; N=1011 vs. N=435) in patients with irritable bowel syndrome with constipation (IBS-C), the most common adverse reactions (incidence > 4%) were nausea (8% vs. 4%), diarrhea (7% vs. 4%), and abdominal pain (5% vs. 5%).

Reduce the dosage in CIC patients with moderate and severe hepatic impairment. Reduce the dosage in IBS-C patients with severe hepatic impairment.

About Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc., an international pharmaceutical company, is focused on the discovery, development and commercialization of proprietary drugs based on prostones. The therapeutic potential of prostones, which occur naturally in the human body as a result of enzymatic (15-PGDH) transformation of certain fatty acids, was first identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals' Chairman and Chief Executive Officer. Dr. Ueno founded Sucampo Pharmaceuticals in 1996 with Sachiko Kuno, Ph.D., founding Chief Executive Officer and currently Advisor, International Business Development, and a member of the Board of Directors. For more information, please visit www.sucampo.com.

AMITIZA is a registered trademark of Sucampo Pharmaceuticals, Inc

Sucampo Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, future financial and operating results, and other statements that are not historical facts. The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the impact of pharmaceutical industry regulation and health care legislation; Sucampo's ability to accurately predict future market conditions; dependence on the effectiveness of Sucampo's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the US and internationally and the exposure to litigation and/or regulatory actions.

No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Sucampo undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this presentation should be evaluated together with the many uncertainties that affect Sucampo's business, particularly those mentioned in the risk factors and cautionary statements in Sucampo's Form 10-K for the year ended Dec. 31, 2011, which the Company incorporates by reference.

Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research & Development Center, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology, gastroenterology, and cardiovascular treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for metabolic and cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.

This press release contains forward-looking statements. Forward-looking statements include statements regarding Takeda's plans, outlook, strategies, results for the future, and other statements that are not descriptions of historical facts. Forward-looking statements may be identified by the use of forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "assume," "continue," "seek," "pro forma," "potential," "target," "forecast," "guidance," "outlook" or "intend" or other similar words or expressions of the negative thereof. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are cautioned not to unduly rely on such forward-looking statements.

Takeda Forward-Looking Statement

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding Takeda's business, including general economic conditions in Japan, the United States and worldwide; (2) competitive pressures and developments; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) actions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates in development; and (8) integration activities with acquired companies.

The forward-looking statements contained in this press release speak only as of the date of this press release, and Takeda undertakes no obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If Takeda does update or correct one or more of these statements, investors and others should not conclude that Takeda will make additional updates or corrections.

Copyright Business Wire 2010

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