DGAP-News: Sucampo to Present Data on AMITIZA(R)

Sucampo Pharmaceuticals, Inc. 13.09.2013 01:00 --------------------------------------------------------------------------- BETHESDA, Md., 2013-09-13 01:00 CEST (GLOBE NEWSWIRE) -- Sucampo AG ('SAG'), a wholly owned subsidiary of Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP) ('Sucampo'), announced today that it will present four posters evaluating the overall efficacy and tolerability of AMITIZA(r) (lubiprostone) as a treatment for chronic idiopathic constipation (CIC). These posters contain data demonstrating the efficacy and tolerability of AMITIZA regardless of age, gender, and race, a pooled analysis of the most frequent adverse events associated with AMITIZA, and an evaluation of the efficacy of AMITIZA in patients suffering from refractory constipation. Sucampo will present these data during the Annual Meeting of the Swiss Society of Gastroenterology in Basel, Switzerland on Friday, September 13, 2013. 'AMITIZA has been proven to be effective in treating a wide range of patients suffering from CIC,' said Ryuji Ueno, MD, PhD, PhD, SAG's President and Chief Scientific Officer. 'We are excited to present these data on AMITIZA, the world's first chloride channel activator, to gastroenterologists in Switzerland.' AMITIZA increases intestinal fluid secretion, softens stools and increases motility in the intestine, thereby facilitating the passage of stool and alleviating symptoms associated with CIC. The following posters will be presented between 1:30-2:00 p.m. CEST (7:30-8:00 a.m. ET) at the Annual Meeting of the Swiss Society of Gastroenterology at the Basel Congress Center in Basel, Switzerland on Friday, September 13, 2013: -- Long-Term Efficacy of Lubiprostone Demonstrated in Patients with Constipation Regardless of Age, Gender or Race -- Taryn R. Joswick, BS, PMP, Gayle R. Dolecek, PD, MPH, Peter Lichtlen MD, PhD, Ryuji Ueno, MD, PhD, PhD, Poster G9 -- Lubiprostone Treatment Improves Constipation and Related Symptoms in Patients Refractory to Other Constipation Therapies -- Taryn R. Joswick, BS, PMP, Raymond M. Panas, PhD, Peter Lichtlen MD, PhD, Ryuji Ueno, MD, PhD, PhD, Poster G10 -- Lubiprostone Demonstrates Efficacy in Adult Patients with Constipation Regardless of Age, Gender or Race -- Taryn Joswick, BS, PMP, Gayle R. Dolecek, PD, MPH, Raymond M. Panas PhD, Ryuji Ueno, MD, PhD, PhD, Poster G11 -- Pooled Analysis of the Most Frequent Adverse Events Associated with the Use of Lubiprostone -- Taryn R. Joswick, BS, PMP, Gayle R. Dolecek, PD, MPH, Ryuji Ueno, MD, PhD, PhD, Poster G12 Sucampo will also be present in the exhibition hall with a booth located at E38. Additional information about the Annual Meeting of the Swiss Society of Gastroenterology can be found at http://www.sgg-sgvc-congress.ch/. About AMITIZA AMITIZA (lubiprostone) capsules are indicated in Switzerland for the treatment of chronic idiopathic constipation (CIC) in adults aged 18 and above. Sucampo began active commercialization of AMITIZA in Switzerland for CIC in the second quarter of 2013. Short Prescribing Information (Switzerland) Before prescribing AMITIZA please consult the full Prescribing Information (www.swissmedicinfo.ch). Composition: Soft capsule, 24 ug lubiprostone. Indication: treatment of chronic idiopathic constipation in adults aged 18 and above. Dosage: One 24 ug capsule should be taken twice daily with food. The need for continued therapy must be assessed at regular intervals by stopping treatment. Contraindication: must not be used for patients with a medical history of known or suspected mechanical gastrointestinal obstructions or with known oversensitivity to the active ingredient or one of the excipients. Precaution: Patients may experience nausea. If this occurs, concomitant administration of food may reduce symptoms. AMITIZA should not be prescribed to patients that have severe diarrhoea. Patients should be aware of the possible occurrence of diarrhoea during treatment and inform their health care provider if diarrhoea becomes severe. No dosage adjustment is required for patients with mild hepatic impairment. For patients with moderate to severe hepatic impairment (Child-Pugh classification B or C), the initial dosage should be decreased to 24 micrograms (1 capsule once a day with breakfast or supper). If the initial dose is tolerated and an adequate response has not been obtained after an appropriate interval, the dose can be increased to full dosing (one capsule twice daily) with appropriate monitoring of patient response. Patients may experience dyspnea within an hour of first dose. This symptom generally resolves within hours, but may recur with repeat dosing. Patients who experience dyspnea should inform their doctor. Interaction: It is unlikely that lubiprostone will cause interactions with other medications. Pregnancy and lactation: AMITIZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Breast-feeding during use of AMITIZA is not recommended. Side effects: Most common in clinical studies (in over 10% of patients) were nausea, diarrhoea and headaches. Other side effects (in over 1% of patients) were abdominal pain, abdominal distension, flatulence, vomiting, dizziness, peripheral oedema, fatigue, chest discomfort or pain, dyspnea, abdominal discomfort, dyspepsia, and dry mouth. Although dyspnea is not classified as severe, some patients discontinued treatment. Packaging: Soft capsules in HDPE bottles of 56 (B) with seal and rayon filler. State of information: May 2013. Sucampo AG, Zug. About Sucampo Sucampo AG, based in Zug, Switzerland, is a wholly-owned subsidiary of Sucampo Pharmaceuticals, Inc., a global biopharmaceutical company focused on innovative research, discovery, development and commercialization of proprietary drugs based on prostones. The therapeutic potential of prostones was first discovered by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo's Chairman, Chief Executive Officer, Chief Scientific Officer, and co-founder. Prostones, naturally occurring fatty acid metabolites that have emerged as promising compounds with unique physiological activities, can be targeted for the treatment of unmet or underserved medical needs. For more information, please visit www.sucampo.com. 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). Twitter LinkedIn CONTACT: Silvia Taylor Senior Vice President, IR, PR, and Corporate Communications 1-240-223-3718 staylor@sucampo.com News Source: NASDAQ OMX 13.09.2013 Dissemination of a Corporate News, transmitted by DGAP - a company of EQS Group AG. The issuer is solely responsible for the content of this announcement. DGAP's Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de --------------------------------------------------------------------------- Language: English Company: Sucampo Pharmaceuticals, Inc. Switzerland Phone: Fax: E-mail: Internet: ISIN: US8649091068 WKN: End of Announcement DGAP News-Service ---------------------------------------------------------------------------