AMITIZA(R) (Lubiprostone) Receives NICE Recommendation

By GlobeNewswire,  June 17, 2014, 08:06:00 PM EDT


BETHESDA, Md., June 17, 2014 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global biopharmaceutical company, today announced that the United Kingdom's (U.K.) National Institute of Health and Care Excellence (NICE) has released a Final Appraisal Determination with guidance for the recommendation of the use of AMITIZA® (lubiprostone) in the treatment of chronic idiopathic constipation (CIC) and associated symptoms in adults who have failed laxatives.

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.1 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.2-3 and approximately 84,000 who have failed two previous laxatives.3 Of these, one-third are men for which there are currently few products broadly reimbursed in the U.K.4

"With more than eight million prescriptions dispensed globally over the past eight years, AMITIZA has demonstrated to be an effective treatment option with a well-tolerated safety profile, and we believe in the value AMITIZA offers to CIC patients in the U.K. who are unresponsive to the treatments that are currently available," stated Peter Greenleaf, Chief Executive Officer of Sucampo. "We are pleased by the NICE recommendation as this will make AMITIZA more widely accessible to patients in the U.K. who may benefit from it, thus continuing our mission of meeting unmet patient needs on a global basis."

This guidance by NICE's appraisal committee recommends lubiprostone as an option for the treatment of patients who are considered to be the most difficult to treat, having failed at least two previous laxatives at maximum tolerated doses for a period of six months, and for whom invasive procedures are being considered.

"Constipation places a significant burden on the U.K. healthcare system, resulting in over 60,000 hospitalizations annually5," 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 here.

About AMITIZA (lubiprostone)

AMITIZA (lubiprostone) is a prostone, a locally acting chloride channel activator, indicated in the United States for the treatment of CIC (24 mcg twice daily) in adults and opioid-induced constipation (OIC) in adults with chronic, non-cancer pain (24 mcg twice daily). The effectiveness in patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established. AMITIZA is also indicated in the U.S. for irritable bowel syndrome with constipation (8 mcg twice daily) in women 18 years of age and older in the U.S. In Japan, AMITIZA (24 mcg twice daily) is indicated for the treatment of chronic constipation (excluding constipation caused by organic diseases). 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. In Switzerland, AMITIZA (24 mcg twice daily) is indicated for the treatment of CIC in adults.

Important Safety Information

  • AMITIZA (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 (HCP) to confirm the absence of such an obstruction prior to initiating AMITIZA treatment.

     
  • Patients taking AMITIZA may experience nausea. If this occurs, concomitant administration of food with AMITIZA may reduce symptoms of nausea. Patients who experience severe nausea should inform their HCP.

     
  • AMITIZA should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment. Patients should be instructed to discontinue AMITIZA and inform their HCP if severe diarrhea occurs.

     
  • Patients taking AMITIZA 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 HCP. Some patients have discontinued therapy because of dyspnea.

     
  • In clinical trials of AMITIZA (24 mcg twice daily vs placebo; N=1113 vs N=316, respectively) in patients with 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 AMITIZA (24 mcg twice daily vs. placebo; N=860 vs. N=632) in patients with OIC, the most common adverse reactions (incidence > 4%) were nausea (11% vs 5%) and diarrhea (8% vs 2%).

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

     
  • Concomitant use of diphenylheptane opioids (e.g., methadone) may interfere with the efficacy of AMITIZA.

     
  • The safety of AMITIZA in pregnancy has not been evaluated in humans. Based on animal data, AMITIZA may cause fetal harm. AMITIZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when AMITIZA is administered to a nursing woman. Advise nursing women to monitor infants for diarrhea.

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

Please see the Full Prescribing Information here. For further information on AMITIZA, please visit www.sucampo.com/products.

About Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc. is focused on the discovery, development and commercialization of drugs based on ion channel activators known as prostones. Prostones are naturally occurring fatty acid metabolites with unique physiological activities. Sucampo has two marketed products - AMITIZA® and RESCULA® - 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, 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.

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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. 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.

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

3. 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.

4. 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.

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

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 HealthLolita McGee, Danielle Guildford-Sharp or Kim Lemon
         +44-(0)-20-8747-2099

Source: Sucampo Pharmaceuticals, Inc.

This article appears in: News Headlines

Referenced Stocks: SCMP


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