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AMITIZA(R) (Lubiprostone) Receives NICE Recommendation

Wed, 06/18/2014 - 9:26am

BETHESDA, Md. - Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global biopharmaceutical company, 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(R) (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.

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