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Sucampo Pharmaceuticals, Inc. (SCMP), Takeda Pharmaceutical Co. Ltd. (TKPYY)'s New Drug Application For AMITIZA® Dealt A Huge Setback



3/14/2014 3:40:40 PM

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Sucampo and Takeda Announce Update on Liquid Formulation Program for AMITIZA(R) (lubiprostone)

BETHESDA, Md., March 14, 2014 (GLOBE NEWSWIRE) -- Sucampo Pharma Americas, LLC, a wholly owned subsidiary of Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), and its development and commercialization partner's subsidiary Takeda Pharmaceuticals U.S.A., Inc. (Takeda) today announced that the New Drug Application (NDA) for the liquid formulation of AMITIZA(R) (lubiprostone) will not be filed in the second half of 2014. In preliminary pre-NDA meeting comments, the FDA informed Sucampo that it would require additional data to characterize pharmacokinetics (PK) of the new formulation.

Sucampo and Takeda announced topline results from a pharmacodynamic, PK and tolerability study of a liquid formulation of AMITIZA in adults with chronic idiopathic constipation (CIC). The study showed directional improvement in spontaneous bowel movement (SBM) frequency in favor of liquid AMITIZA compared to placebo, but did not reach statistical significance. The safety profile observed in this study was consistent with previous clinical studies of AMITIZA. As a result of this outcome in conjunction with the FDA feedback, Sucampo and Takeda are now assessing next steps, which may include formulation modification. The companies are also evaluating potential impact to the timing of initiation of the second pivotal trial in the global, multicenter Phase 3 program for pediatric functional constipation in children aged 6 months to less than 6 years, as the liquid formulation would be required for this study.

"As we have previously disclosed, our goals in developing a liquid formulation of AMITIZA are to help meet the needs of patients who will not take AMITIZA in its capsule form, as well as to support our pediatric clinical program," said Peter Greenleaf, Sucampo's Chief Executive Officer. "The FDA feedback and study results provide useful direction as we seek to develop an alternative formulation of AMITIZA for a wider range of patients who may need it."

About (AMITIZA) lubiprostone

AMITIZA (lubiprostone) 24 mcg capsules twice daily is approved to treat Chronic Idiopathic Constipation (CIC) in adults. "Idiopathic" means the cause of the constipation is unknown and not due to an underlying illness or medication. AMITIZA 24 mcg twice daily is also approved to treat constipation caused by opioids, a type of prescription pain medicine, in adults with chronic, noncancer pain. The effectiveness of AMITIZA has not been established if you are taking a diphenylheptane opioid (e.g., methadone). AMITIZA 8 mcg capsules twice daily is approved to treat Irritable Bowel Syndrome with Constipation (IBS-C) in women 18 years of age and older.

Sucampo and Takeda are developing a liquid formulation of AMITIZA for patients who will not take a capsule, such as certain pediatric and long-term care patients.

Important Safety Information

AMITIZA (lubiprostone) is not for everyone. If you know or suspect you have a bowel blockage, do not take AMITIZA. If you are unsure, your healthcare provider (HCP) should evaluate your condition before starting AMITIZA. You should not take AMITIZA if you have severe diarrhea.

Some patients taking AMITIZA may experience nausea or diarrhea. If nausea occurs, take AMITIZA with food and water, if it becomes severe, tell your HCP. If your diarrhea becomes severe, stop taking AMITIZA and tell your HCP.

Within an hour of taking AMITIZA, a sensation of chest tightness and shortness of breath may occur. These symptoms usually go away within three hours, but may recur with repeated use. Tell your HCP if you experience these symptoms.

The most common side effects of taking AMITIZA (24 mcg) twice daily are nausea, diarrhea, headache, abdominal pain, abdominal distension, and gas for patients treated for CIC; nausea and diarrhea for patients treated for Opioid-Induced Constipation. The most common side effects of taking AMITIZA (8 mcg) twice daily for IBS-C are nausea, diarrhea, and abdominal pain. These are not all the side effects associated with AMITIZA.

Tell your HCP if you are taking a diphenylheptane opioid (e.g. methadone).

AMITIZA has not been studied in pregnant women. Based on animal studies, AMITIZA may cause fetal harm. AMITIZA should only be used during pregnancy if the potential benefits justify the potential risk to the fetus. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your HCP to evaluate the risks to the fetus. Tell your HCP if you are nursing and monitor infants for diarrhea.

Tell your HCP if you have liver problems.

For further information, please visit www.sucampo.com/products for complete Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

About Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc. is focused on the discovery, development and commercialization of drugs based on ion channel activators knows as prostones. Discovered by the company's scientific co-founder, Ryuji Ueno, M.D., Ph.D., Ph.D., prostones are naturally occurring fatty acid metabolites with unique physiological activities. Sucampo has two marketed products -- AMITIZA and RESCULA(R) -- and a pipeline of prostone-based product candidates in clinical development. A global company, Sucampo is headquartered in Bethesda, Maryland, and has operations in Japan, the United Kingdom and Switzerland. For more information, please visit www.sucampo.com.

The Sucampo logo and the tagline, The Science of Innovation, are registered trademarks of Sucampo AG. AMITIZA is a registered trademark of Sucampo AG. RESCULA is a registered trademark of R-Tech Ueno, Ltd, and has been licensed to Sucampo AG.

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 U.S. 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 most recent Form 8-K and 10-K, which Sucampo incorporates by reference.

Follow us on Twitter (@Sucampo_Pharma). Follow us on LinkedIn (Sucampo Pharmaceuticals).

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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.takeda.us.

Takeda Forward-Looking Statement

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.

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.

CONTACT: Silvia Taylor
Senior Vice President, Investor Relations and
Corporate Communications
Sucampo Pharmaceuticals, Inc.
1-240-223-3718
staylor@sucampo.com

Roseanne Durril
Takeda Pharmaceuticals U.S.A., Inc.
1-224-554-1474
roseanne.durril@takeda.com

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