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Sucampo Pharmaceuticals, Inc. (SCMP) Announces Publication of NICE Recommendation for AMITIZA(R) (Lubiprostone)


7/23/2014 12:48:33 PM

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BETHESDA, Maryland and ABINGDON, Oxfordshire, July 23, 2014 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global biopharmaceutical company, today announced that the United Kingdom's National Institute of Health and Care Excellence (NICE) has published the technology appraisal guidance recommending the use of AMITIZA® (lubiprostone) in the treatment of chronic idiopathic constipation (CIC) and associated symptoms in adults who have failed laxatives.

The NICE guidance recommends AMITIZA as an option for treating CIC for adults in whom treatment with at least 2 laxatives from different classes, at the highest tolerated recommended doses for at least 6 months, has failed to provide adequate relief and for whom invasive treatment for constipation is being considered.

"We are pleased that NICE has published its recommendation for AMITIZA today, as this will make AMITIZA more widely accessible to patients in the U.K. who may benefit from it," stated Peter Greenleaf, Chief Executive Officer of Sucampo. "Through more than eight years of experience and eight million prescriptions dispensed globally, AMITIZA has been demonstrated to be an effective treatment option with a well-tolerated safety profile. Today's NICE recommendation for AMITIZA is an important step in allowing us to fulfill Sucampo's mission of meeting unmet patient needs in the U.K., and on a global basis."

NICE regulations require that clinical commissioning groups, National Health Service England and local authorities comply with NICE recommendations within three months of the date of publication. Specifically, the NICE guidance for AMITIZA states that "if a patient has chronic idiopathic constipation and the doctor responsible for their care thinks that lubiprostone is the right treatment, it should be available for use, in line with NICE's recommendations."1

"Constipation places a significant burden on the U.K. healthcare system, resulting in over 60,000 hospitalizations annually,"2 said Dr. Ramesh Arasaradnam, University Hospitals Coventry and Warwickshire NHS Trust and University of Warwick. "For many of the patients who are refractory to standard laxatives, effectively treating with lubiprostone in primary care could negate the need to progress to a secondary or tertiary care referral."

According to June Rogers, MBE, Team Director of PromoCon*, "Chronic constipation has a detrimental impact on the quality of life of thousands of patients, particularly in the elderly. PromoCon is delighted that this guidance recognizes the burden of chronic constipation, as we believe that providing innovative medicines in primary care will improve the healthcare of CIC patients."

AMITIZA was approved by the Medicines and Healthcare Products Regulatory Agency in September 2012 for the treatment of CIC and associated symptoms in adults, when response to diet and other non-pharmacological measures (e.g. educational measures, physical activity) are inappropriate, and was made commercially available in the U.K. in December 2013.

For the full guidance from NICE on the usage of AMITIZA in the U.K., please visit http://www.nice.org.uk/guidance/TA318

About Chronic Idiopathic Constipation

Constipation is characterized by infrequent and difficult passage of stool and becomes chronic when a person suffers specified symptoms (such as, but not limited to, straining, hard stools, and sensation of incomplete evacuation) for a period of three months with symptom onset at least six months prior to diagnosis.3 Chronic constipation is idiopathic if it is not caused by other diseases or by the use of medications. CIC is a debilitating condition that affects millions worldwide with an estimated 300,000 patients under the care of a general practitioner in the U.K.4-5 and approximately 84,000 who have failed two previous laxatives.5 Of these, one-third are men for which there are currently few products broadly reimbursed in the U.K.6

About AMITIZA (lubiprostone)

In the U.K., AMITIZA (24 mcg twice daily) is indicated for the treatment of CIC and associated symptoms in adults, when response to diet and other non-pharmacological measures (e.g., educational measures, physical activity) are inappropriate.

Important Safety Information (U.K.)

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.

There are no or limited data from the use of lubiprostone in pregnant women. Patients who become pregnant or are planning a pregnancy should be advised to consider the risks and benefits of continued AMITIZA therapy during pregnancy.

Nausea is the most commonly reported adverse drug reaction observed in pivotal clinical studies of AMITIZA, with 23.6% of patients experiencing at least one treatment related nausea event; however, of those patients, 93% reported only a single event during treatment with AMITIZA. Of all reported nausea events, 93.7% were mild to moderate in severity, and 4.0% discontinued treatment as a result of nausea. Administration of AMITIZA with food has been shown to reduce symptoms of nausea.

AMITIZA should not be prescribed to patients that have severe diarrhoea. Patients should be aware of the possible occurrence of diarrhoea during treatment. Patients should be instructed to inform their physician if severe diarrhoea occurs.

Dyspnea or chest discomfort/pain (usually described as a sensation of chest tightness and/or difficulty taking in a breath) has been reported shortly after taking AMITIZA, and some patients have discontinued treatment. These symptoms generally resolve within a few hours of dosing, but recurrence has been frequently reported with subsequent doses. If these symptoms occur, the patient should seek medical advice before resuming treatment.

The safety of AMITIZA has been investigated in 301 patients in 3 pivotal clinical studies. During the pivotal clinical studies conducted on AMITIZA, a number of ADRs have been reported. The most common ADR reported by patients taking AMITIZA was nausea, with diarrhoea and headache also being commonly reported. Treatment-emergent adverse events led to premature study discontinuation for 8% of patients in the pivotal clinical studies.

Please visit http://www.amitiza.co.uk for complete Prescribing Information and for further information.

About Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc. is focused on the discovery, development and commercialization of medicines to meet the major unmet medical needs of patients on a global basis. Sucampo has two marketed products – AMITIZA® and RESCULA® – and a pipeline of product candidates in clinical development. A global company, Sucampo is headquartered in Bethesda, Maryland, and has operations in Japan, Switzerland and the U.K. For more information, please visit www.sucampo.com.

The Sucampo logo is the registered trademark and the tagline, The Science of Innovation, is a pending trademark 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.

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

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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.

*PromoCon provides a national service, working as part of Disabled Living, Manchester to improve the life for all people with bladder or bowel problems by offering product information, advice and practical solutions to both professionals and the general public.

References:

1. National Institute for Health and Care Excellence Technology Appraisal Guidance 318, "Lubiprostone for treating chronic idiopathic constipation." Issued: July 2014.

2. Hospital Episode Statistics 2012/13: Admitted Patient Care. November 2013.

3. Rome Foundation. Rome III Diagnostic Criteria for Functional Gastrointestinal Disorders. Available at: http://www.romecriteria.org/assets/pdf/19_RomeIII_apA_885-898.pdf. Accessed 28 May 2014.

4. National Horizon Scanning Centre. Prucalopride (Resolor) for chronic constipation Birmingham: National Horizon Scanning Centre (NHSC). Horizon Scanning Technology Briefing. 2008.

5. Shafe AC. The LUCK study: Laxative Usage in patients with GP-diagnosed Constipation in the UK, within the general population and in pregnancy. An epidemiological study using the General Practice Research Database (GPRD). Therap Adv Gastroenterol. (2011) 4(6): 343-363.

6. Muller-Lissner S, Tack J, Feng Y, et al. (2013) Levels of satisfaction with current chronic constipation treatment options in Europe - an internet survey. Aliment Pharmacol Ther. 37(1): 137-145.

CONTACT: Sucampo Pharmaceuticals, Inc. Silvia Taylor Senior Vice President, Investor Relations and Corporate Communications 1-240-223-3718 staylor@sucampo.com For U.K. and European Media Inquiries: Creston Health Lolita McGee, Danielle Guildford-Sharp or Kim Lemon +44-(0)-20-8747-2099

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