Sucampo Announces Approval of Supplemental Application for Updates to AMITIZA; Stock Halted Following News

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that the Companyreceived a supplement approval from the U.S. Food and Drug Administration(FDA) that removes pregnancy “warnings and precautions” and clarifiesinformation regarding the use of AMITIZA^® (lubiprostone) by pregnant and/ornursing women. In addition, the FDA expanded the labeling text of theMechanism of Action section in the prescribing information for AMITIZA.AMITIZA is approved for the treatment of chronic idiopathic constipation (CIC)in adults (24 mcg twice daily) and irritable bowel syndrome with constipation(IBS-C) in women 18 years of age and older (8 mcg twice daily).The Company also announced today that the FDA has extended the PrescriptionDrug User Fee Act (PDUFA) goal date for the Agency's priority review of thesupplemental new drug application (sNDA) filing seeking approval for anadditional indication for lubiprostone for the treatment of opioid-inducedconstipation (OIC) in patients with chronic, non-cancer pain. Sucampo wasnotified that its November 16, 2012 submission of FDA-requested supportiveanalyses has been designated as a major amendment to the application. Sincethe receipt date of this additional information is within three months of thePDUFA date, the FDA has decided to extend the goal date by three months toprovide time for a full review of the submission. The extended user fee goaldate is late April, 2013. No new clinical trials or studies have beenrequested by the FDA.Sucampo has accepted the following FDA-approved labeling changes, which willbe effective immediately: 1. All pregnancy-related Warnings and Precautions (Section 5.1 of the label) have been removed. This includes deletion of the sentence: “Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with AMITIZA and should be capable of complying with effective contraceptive measures.” 2. Section 8 of the product labeling, “Use in Specific Populations,” was updated to include additional animal data and a Clinical Consideration section, with the pregnancy category remaining unchanged. 3. Previous labeling statements regarding the potential for serious adverse reactions in nursing infants have been removed. The revised label states that caution should be exercised when AMITIZA is administered to a nursing mother and advises “lactating women to monitor their human milk-fed infants for diarrhea while taking AMITIZA.” 4. The Mechanism of Action section (Section 12.1) of the label now reads as follows: “Lubiprostone is a locally acting chloride channel activator…activation of ClC-2 by lubiprostone has been shown to stimulate recovery of mucosal barrier function and reduce intestinal permeability (bolding added to indicate label addition) via the restoration of tight junction complexes in ex vivo studies of ischemic porcine intestine.”