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Salix Pharmaceuticals Reports 2Q2012 Results

Carolyn Logan, President and Chief Executive Officer, stated, “Our second quarter growth was driven primarily by XIFAXAN 550, APRISO and RELISTOR. XIFAXAN continues to grow sequentially, with prescriptions, on a milligram basis, increasing 4% for the second quarter of 2012 compared to the first quarter of 2012. APRISO also continued to exceed the Company’s expectations during the quarter. APRISO prescriptions increased 6% during the second quarter of 2012 compared to the first quarter of 2012. RELISTOR prescriptions increased 11% during the second quarter of 2012 compared to the first quarter of 2012.

“Salix continued to execute its plan and to progress in the commercial and product development arenas during the second quarter of 2012. Our expanded 192-member office-based sales force is focused primarily on gastroenterologists, colorectal surgeons and hepatologists. One 96-member division of the sales force is promoting XIFAXAN 550, RELISTOR and APRISO. The second 96-member division of the sales force is promoting SOLESTA, XIFAXAN 550, MOVIPREP/OSMOPREP, and APRISO. Our 40-member institutional sales force is promoting XIFAXAN 550, RELISTOR and DEFLUX.

“As previously announced, the FDA notified the Company that it required additional time for review of the supplemental New Drug Application (sNDA) for RELISTOR (methylnaltrexone bromide) injection for subcutaneous use for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain and extended the April 27, 2012 goal date by three months to July 27, 2012. On July 27, 2012 the FDA issued a Complete Response Letter (CRL) requesting additional clinical data. Salix has requested an End-of-Review meeting with the Division of Gastroenterology and Inborn Errors Products to better understand the contents of the letter.

“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. On April 20, 2012 the FDA notified the Company that it required additional time for review of the New Drug Application (NDA) for Crofelemer 125 mg tablets and extended the June 5, 2012 goal date by three months to September 5, 2012. We anticipate receiving the FDA’s decision regarding the NDA by the extended PDUFA goal date.

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