“We continue to anticipate an action by the FDA by the end of the first quarter of 2013 on our 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.
Both the FDA and Salix are continuing to work collaboratively to progress this important product through its full review. To date, this collaboration has resulted in substantial progress in handling topics important to crofelemer as well as to future botanical products in general. The primary focus of our collaboration is the production and control of the crofelemer active pharmaceutical ingredient in order to ensure compliance with the manufacturing and product quality requirements of the Federal Food, Drug & Cosmetic Act. Both Salix and the FDA are committed to a robust level of cooperation and data exchange with the goal of providing crofelemer to patients suffering from the very important unmet need of the indication for which we are seeking approval. Our efforts to date have advanced both the chemical and the regulatory science methods available to ensure the quality and clinical usefulness of crofelemer and, potentially, other products that are of botanical origin.
“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 (IBS-D) who respond to an initial treatment course with rifaximin 550 mg TID for 14 days. During the third quarter we continued 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. We initiated patient enrollment in TARGET 3 during the first half of 2012 and currently anticipate securing a FDA decision regarding approvability during the first half of 2014. We continue to strengthen our intellectual property relating to rifaximin for the treatment of IBS-D. A method of treatment patent regarding XIFAXAN550 for the treatment of IBS-D should issue November 13, 2012 and should provide protection until 2029.