“On February 7, 2012 the FDA issued an action date of June 5, 2012 under PDUFA and granted Priority Review designation for the NDA for Crofelemer 125 mg tablets for the proposed indication of the control and symptomatic relief of diarrhea in patients with human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) on anti-retroviral therapy. The FDA recently notified the Company that it requires additional time for review of the New Drug Application (NDA) for Crofelemer 125 mg tablets and has extended the June 5, 2012 goal date by three months. The extended user fee goal date is September 5, 2012. We look forward to working with the FDA to complete the review of the NDA by the extended PDUFA goal date.
“On February 21, 2012 the Company initiated TARGET 3 - a Phase 3 study to evaluate the efficacy and safety of repeat treatment with rifaximin 550 mg TID (three times daily) for 14 days in subjects with irritable bowel syndrome with diarrhea who respond to an initial treatment course with rifaximin 550 mg TID for 14 days. We are working to enroll a number of subjects sufficient to randomize approximately 800 subjects (400 subjects per treatment group) into the double blind retreatment phase of the study. The study will be conducted in approximately 250 sites throughout the United States. The Company continues to anticipate that from study initiation it could take approximately 24 months to complete the trial, submit a response to the Complete Response Letter and secure a FDA decision regarding approvability.
“During the first quarter of 2012 the Company also continued to make progress in the development of oral RELISTOR, budesonide foam, the next generation formulation of rifaximin for potential additional indications and Lumacan. Detailed results of the 804-patient Phase 3 trial to evaluate the efficacy and safety of oral methylnaltrexone bromide for the treatment of opioid–induced constipation (OIC) in subjects with chronic, non–cancer pain are to be presented at Digestive Disease Week on May 22, 2012. The highly statistically significant results of this study constitute the basis of the New Drug Application the Company is targeting to submit to the FDA during the third quarter of 2012. We anticipate completing patient enrollment in our two budesonide foam Phase 3 trials by the end of 2012. In December 2011 we initiated a pharmacokinetic study to assist in the characterization of three prototype tablet formulations of rifaximin. The study progressed during the first quarter of 2012 and currently we intend to move forward with a suitable next generation rifaximin candidate or candidates with the initiation of a clinical trial by the end of 2012. Work continued to progress on the development of Lumacan formulation prototypes. We intend to test various formulation prototypes in the clinic during 2012. We believe that Lumacan, if approved, has the potential to significantly improve the earlier detection and diagnosis of colon cancer.
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